LONGBOARD LIFE
We are committed to improving the quality of life for individuals with devastating neurological conditions. Our team works together to create a company culture and welcoming environment we are proud to be a part of. We are looking for dynamic, talented, and passionate people to join our team.
View open positions here
Life at Longboard
Our Mission
We are committed to transforming the lives of patients, families, and caregivers impacted by neurological and rare diseases.
Our Vision
A world where devastating neurological conditions are no longer devastating.
Our Values
Open Positions
Longboard Pharmaceuticals is an equal-opportunity employer offering a competitive benefit package. Our open positions are listed below. To apply, please click on the position of interest.
If the position you are looking for is not listed, please check back in the future.
Job Title: Site Engagement and Enrollment Manager, APAC
Reporting To: Site Engagement and Enrollment Lead
Department: R&D: Clinical Operations
People Manager: No
Location: Remote, in APAC
Position Summary
The Site Engagement and Enrollment Lead is responsible to lead the development and effective partnership building to deliver the company portfolio, including the engagement with external and external partners to develop and execute site performance success and provide a level of service to make Longboard a top choice for sites to partner. This role is also a key contributor to the delivery and patient allocation that is designed to meet regulatory requirements based in understanding healthcare environment and site capabilities. The Site Engagement and Enrollment Lead will ensure a superior site experience to drive patient enrollment and retention. They will provide leadership with oversight, accountability, and responsibility for site strategy implementation which has direct impact on enrollment optimization.
This is a unique opportunity to build and develop site partnerships and design integrated study level enrollment plans in collaboration with the clinical study teams. The Site Engagement and Enrollment Lead will also build strong cross-functional relationships with internal and external stakeholders to ensure all input is factored into defining patient recruitment strategies and that there is close collaboration in the execution of those strategies for each study duration. They will ensure that enrollment plans and processes enable trial participation, and include novel capabilities to increase access to, and engagement with, clinical trials for diverse representative populations.
For international roles, Longboard partners with local Employer of Record (EOR) Velocity Global to manage salary/benefits of international employees. Benefits are country-specific but generally include medical, vision, and dental insurance, parental leave, mental health support, and more.
Responsibilities include but may not be limited to:
- Develop and cultivate strategic long-term relationships with key sites. Establish and manage executive-level relations with site decision makers and influencers.
- Oversight of all site strategy, engagement and optimization activities related to internal and external projects teams.
- Ensure that multiple novel ideas on site engagement and optimization to improve clinical trials quality and delivery are generated and considered in alignment with broader strategic initiatives.
- Provide leadership with oversight, accountability and responsibility for site strategy implementing integrated enrollment plans. Define strategic and tactical activities and deliverables that the cross functional program teams will implement to ensure successful study recruitment.
- Collaboration with Program Teams setting and tracking site specific metrics, collaborating with internal stakeholders to prioritize key partnership sites and activities, and reporting of key achievements.
- Leads collaboration with program teams and management to identify, develop and execute on study specific opportunities to drive site performance.
- Collaborates with internal stakeholders to review potential site facing vendors and platforms to identify potential opportunities and develop initial onboarding and utilization strategy.
- Collaborates with outsourced partners to provide input into site lists and assures operational efficiencies are utilized and implemented.
- Serves at the Company primary liaison to activities and initiative relative to site facing programs
- Responsible for real time cross-functional collaboration to share performance predictions, develop solution programs and identify potential risk to delivery to drive quick response
- Leads collaboration with Program Teams and management to identify, develop and execute on study specific opportunities to drive site performance.
Minimum Requirements
- Bachelor’s degree required, advanced degree preferred
- 8-10+ years in clinical research, site engagement, or enrollment management within the pharmaceutical or biotechnology industry, preferred
- High level of proficiency in English (ideally English as a primary language)
- Have reliable home internet
- Can work a schedule that sometimes overlaps with a typical US East Coast work day (9am – 5pm GMT)
- Proven track record in a leadership role, demonstrating successful management of enrollment strategies, team leadership, and achievement of enrollment goals
- In-depth understanding of clinical trial operations, enrollment processes, regulatory requirements, and ethical considerations within the pharmaceutical industry
- Strong leadership abilities with experience in leading and managing teams, setting strategic direction, and driving performance
- Excellent managerial and interpersonal skills are crucial
- Exceptional communication skills to effectively engage with diverse stakeholders including site staff, investigators, cross-functional teams, and external partners.
- Ability to build and maintain strong professional relationships is vital
- Proficiency in data analysis, metrics interpretation, and the ability to develop and execute strategic plans for site engagement and enrollment improvement
- Knowledge and understanding of regulatory compliance standards and ethical guidelines governing clinical research studies
- Flexibility to adapt to changing environments and ability to navigate challenges and solve problems efficiently
- Experience in managing budgets and resources effectively, optimizing expenditure while ensuring successful enrollment outcomes
- Travel up to 25%
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Job Title: Site Engagement and Enrollment Manager, Europe
Reporting To: Site Engagement and Enrollment Lead
Department: R&D: Clinical Operations
People Manager: No
FLSA Status: Exempt
Location: Remote
Position Summary
The Site Engagement and Enrollment Lead is responsible to lead the development and effective partnership building to deliver the company portfolio, including the engagement with external and external partners to develop and execute site performance success and provide a level of service to make Longboard a top choice for sites to partner. This role is also a key contributor to the delivery and patient allocation that is designed to meet regulatory requirements based in understanding healthcare environment and site capabilities. The Site Engagement and Enrollment Lead will ensure a superior site experience to drive patient enrollment and retention. They will provide leadership with oversight, accountability, and responsibility for site strategy implementation which has direct impact on enrollment optimization.
This is a unique opportunity to build and develop site partnerships and design integrated study level enrollment plans in collaboration with the clinical study teams. The Site Engagement and Enrollment Lead will also build strong cross-functional relationships with internal and external stakeholders to ensure all input is factored into defining patient recruitment strategies and that there is close collaboration in the execution of those strategies for each study duration. They will ensure that enrollment plans and processes enable trial participation, and include novel capabilities to increase access to, and engagement with, clinical trials for diverse representative populations.
For international roles, Longboard partners with local Employer of Record (EOR) Velocity Global to manage salary/benefits of international employees. Benefits are country-specific but generally include medical, vision, and dental insurance, parental leave, mental health support, and more.
Responsibilities include but may not be limited to:
- Develop and cultivate strategic long-term relationships with key sites. Establish and manage executive-level relations with site decision makers and influencers.
- Oversight of all site strategy, engagement and optimization activities related to internal and external projects teams.
- Ensure that multiple novel ideas on site engagement and optimization to improve clinical trials quality and delivery are generated and considered in alignment with broader strategic initiatives.
- Provide leadership with oversight, accountability and responsibility for site strategy implementing integrated enrollment plans. Define strategic and tactical activities and deliverables that the cross functional program teams will implement to ensure successful study recruitment.
- Collaboration with Program Teams setting and tracking site specific metrics, collaborating with internal stakeholders to prioritize key partnership sites and activities, and reporting of key achievements.
- Leads collaboration with program teams and management to identify, develop and execute on study specific opportunities to drive site performance.
- Collaborates with internal stakeholders to review potential site facing vendors and platforms to identify potential opportunities and develop initial onboarding and utilization strategy.
- Collaborates with outsourced partners to provide input into site lists and assures operational efficiencies are utilized and implemented.
- Serves at the Company primary liaison to activities and initiative relative to site facing programs
- Responsible for real time cross-functional collaboration to share performance predictions, develop solution programs and identify potential risk to delivery to drive quick response
- Leads collaboration with Program Teams and management to identify, develop and execute on study specific opportunities to drive site performance.
Minimum Requirements
- Bachelor’s degree required, advanced degree preferred
- 8-10+ years in clinical research, site engagement, or enrollment management within the pharmaceutical or biotechnology industry, preferred
- High level of proficiency in English (ideally English as a primary language)
- Have reliable home internet
- Can work a schedule that generally overlaps with a typical US East Coast work day (9am – 5pm GMT)
- Proven track record in a leadership role, demonstrating successful management of enrollment strategies, team leadership, and achievement of enrollment goals
- In-depth understanding of clinical trial operations, enrollment processes, regulatory requirements, and ethical considerations within the pharmaceutical industry
- Strong leadership abilities with experience in leading and managing teams, setting strategic direction, and driving performance
- Excellent managerial and interpersonal skills are crucial
- Exceptional communication skills to effectively engage with diverse stakeholders including site staff, investigators, cross-functional teams, and external partners.
- Ability to build and maintain strong professional relationships is vital
- Proficiency in data analysis, metrics interpretation, and the ability to develop and execute strategic plans for site engagement and enrollment improvement
- Knowledge and understanding of regulatory compliance standards and ethical guidelines governing clinical research studies
- Flexibility to adapt to changing environments and ability to navigate challenges and solve problems efficiently
- Experience in managing budgets and resources effectively, optimizing expenditure while ensuring successful enrollment outcomes
- Travel up to 25%
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Job Title: Site Engagement and Enrollment Manager, North America
Reporting To: Site Engagement and Enrollment Lead
Department: R&D: Clinical Operations
People Manager: No
FLSA Status: Exempt
Location: Remote or Hybrid (2-3 days a week) out of San Diego office
Position Summary
The Site Engagement and Enrollment Lead is responsible to lead the development and effective partnership building to deliver the company portfolio, including the engagement with external and external partners to develop and execute site performance success and provide a level of service to make Longboard a top choice for sites to partner. This role is also a key contributor to the delivery and patient allocation that is designed to meet regulatory requirements based in understanding healthcare environment and site capabilities. The Site Engagement and Enrollment Lead will ensure a superior site experience to drive patient enrollment and retention. They will provide leadership with oversight, accountability, and responsibility for site strategy implementation which has direct impact on enrollment optimization.
This is a unique opportunity to build and develop site partnerships and design integrated study level enrollment plans in collaboration with the clinical study teams. The Site Engagement and Enrollment Lead will also build strong cross-functional relationships with internal and external stakeholders to ensure all input is factored into defining patient recruitment strategies and that there is close collaboration in the execution of those strategies for each study duration. They will ensure that enrollment plans and processes enable trial participation, and include novel capabilities to increase access to, and engagement with, clinical trials for diverse representative populations.
Responsibilities include but may not be limited to:
- Develop and cultivate strategic long-term relationships with key sites. Establish and manage executive-level relations with site decision makers and influencers.
- Oversight of all site strategy, engagement and optimization activities related to internal and external projects teams.
- Ensure that multiple novel ideas on site engagement and optimization to improve clinical trials quality and delivery are generated and considered in alignment with broader strategic initiatives.
- Provide leadership with oversight, accountability and responsibility for site strategy implementing integrated enrollment plans. Define strategic and tactical activities and deliverables that the cross functional program teams will implement to ensure successful study recruitment.
- Collaboration with Program Teams setting and tracking site specific metrics, collaborating with internal stakeholders to prioritize key partnership sites and activities, and reporting of key achievements.
- Leads collaboration with program teams and management to identify, develop and execute on study specific opportunities to drive site performance.
- Collaborates with internal stakeholders to review potential site facing vendors and platforms to identify potential opportunities and develop initial onboarding and utilization strategy.
- Collaborates with outsourced partners to provide input into site lists and assures operational efficiencies are utilized and implemented.
- Serves at the Company primary liaison to activities and initiative relative to site facing programs
- Responsible for real time cross-functional collaboration to share performance predictions, develop solution programs and identify potential risk to delivery to drive quick response
- Leads collaboration with Program Teams and management to identify, develop and execute on study specific opportunities to drive site performance.
Minimum Requirements
- Bachelor’s degree required, advanced degree preferred
- 8-10+ years in clinical research, site engagement, or enrollment management within the pharmaceutical or biotechnology industry, preferred
- Proven track record in a leadership role, demonstrating successful management of enrollment strategies, team leadership, and achievement of enrollment goals
- In-depth understanding of clinical trial operations, enrollment processes, regulatory requirements, and ethical considerations within the pharmaceutical industry
- Strong leadership abilities with experience in leading and managing teams, setting strategic direction, and driving performance
- Excellent managerial and interpersonal skills are crucial
- Exceptional communication skills to effectively engage with diverse stakeholders including site staff, investigators, cross-functional teams, and external partners.
- Ability to build and maintain strong professional relationships is vital
- Proficiency in data analysis, metrics interpretation, and the ability to develop and execute strategic plans for site engagement and enrollment improvement
- Knowledge and understanding of regulatory compliance standards and ethical guidelines governing clinical research studies
- Flexibility to adapt to changing environments and ability to navigate challenges and solve problems efficiently
- Experience in managing budgets and resources effectively, optimizing expenditure while ensuring successful enrollment outcomes
- Travel up to 25%
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $150,000.00 – $170,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
- Hybrid work schedule out of our La Jolla office, 2-3 days a week
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Job Title: Clinical Research Associate (CRA or Senior CRA; In-House)
Reporting To: Director, Clinical Line Management
Department: R&D: Clinical Operations
People Manager: No
Location: Remote, based in Europe.
Position Summary
The Clinical Research Associate (CRA) supports global and regional clinical trial managers and trial leaders in the planning, designing, executing, monitoring, and reporting of clinical trials. The In-House Clinical Research Associate partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to, essential document collection and review; investigative site recruitment & feasibility; FDA/GCP/ICH and regulatory compliance; data management and query resolution; document and SOP review; study document/plan development and review; maintenance and close-out of in-house site management activities; and clinical operations support activities and tasks.
For international roles, Longboard partners with local Employer of Record (EOR) Velocity Global to manage salary/benefits of international employees. Benefits are country-specific but generally include medical, vision, and dental insurance, parental leave, mental health support, and more.
Responsibilities include but may not be limited to:
This role will be based in Europe.
- Supports the global and regional clinical trial managers and trial leaders in the planning, execution, and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP, and applicable regulatory guidelines
- Performs an array of assigned duties including investigator site recruitment/feasibility; essential document collection and review; ICF review; study document/plan development and review; maintenance and close-out of in-house site management activities in accordance with the protocol; review and compliance with standard operating procedures (SOPs); ICH/GCP guidelines and all applicable regulatory requirements
- Assists in the review and approval of monitoring reports
- May conduct co-monitoring or observational visits at investigational sites
- Assists with the preparation and finalization of investigators’ contracts, budgets, and payments
- Obtain, review (to ensure completeness, accuracy, and regulatory compliance), and process essential regulatory, and administrative documents, and Informed Consent Forms (ICFs)
- Works with Technical Operations and/or CTAs to Initiate investigational product shipments as needed and ensures that supplies are adequate/appropriate for assigned studies and sites
- Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product), and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities
- Ongoing interaction with clinical operations team members and Investigator site staff to obtain and relay key study issues, status updates, and other study information to the clinical trial team and management
- Participates in the development and improvement of department processes, best practices, and tools and templates related to clinical trial management and operations
- Participates in the review and development of CRFs and CRF guidelines
- Performs in-house review of CRF data for completeness and accuracy, and resolves data management/query issues with study sites and vendors as needed
- Reviews data to identify protocol deviations and risks to subject safety/data integrity
- Works with CTAs to obtain licensing for study tools and assessments
- Evaluates the execution of the study protocol at the site level. Uses judgment and experience to evaluate the overall performance of site and site staff to provide recommendations regarding site-specific actions; immediately communicates/escalate serious issues to the study team
- Work with assigned CTAs and CROs to ensure study activities are documented via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and the Study Monitoring Plan
- Supports and monitors clinical trials to ensure sponsor and investigator obligations are met and in compliance with the currently approved protocol/amendment(s); applicable study procedures; applicable federal and local regulatory requirements; GCP; and company policy and procedures
- Supports the oversight of all activities listed and ensures all duties/documents/protocols/etc. meet Longboard’s expectations, and delivers them in accordance with the sponsor’s expectations, trial protocol, ICH/GCP guidelines, and applicable SOPs (local/US/international)
- Verifies that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents
- Performs other work-related duties as assigned or required
Minimum Requirements
- Bachelor’s degree, preferred
- 5+ years of relevant and progressive experience with clinical trials
- High level of proficiency in English (ideally English as a primary language)
- Have reliable home internet
- Can work a schedule that sometimes overlaps with a typical US East Coast work day (9am – 5pm GMT)
- Experience in all stages of clinical trial conduct (study start-up, maintenance, database lock, etc.) and a strong understanding of clinical trial processes, protocols, and medical terminology
- Prior experience in management and monitoring of CRO and investigative sites, preferred
- Experience with patient recruitment, non-compliance, safety, document management, an investigational product, IP accountability
- Strong written and verbal communication and computer literacy (e.g., Microsoft Word, Excel, PowerPoint, Outlook); strong experience utilizing CTMS, EDC, TMS, and related software
- Knowledge of ICH GCP, IRB/IEC, and local regulatory authority drug research & development regulations
- Motivated to work in a fast-paced, high-accountability environment
- Experience with bio-samples, storage of 3rd party data, and preferred
- Experience in Longboard’s focused therapeutic areas, preferred
- Travel up to 35%
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Clinical Research Associate – Longboard Pharmaceuticals, Inc. – Career Page (applytojob.com)
Job Title: Clinical Research Associate (CRA or Senior CRA; In-House)
Reporting To: Director, Clinical Line Management
Department: R&D: Clinical Operations
People Manager: No
Location: Remote, based in Australia
Position Summary
The Clinical Research Associate (CRA) supports global and regional clinical trial managers and trial leaders in the planning, designing, executing, monitoring, and reporting of clinical trials. The In-House Clinical Research Associate partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to, essential document collection and review; investigative site recruitment & feasibility; FDA/GCP/ICH and regulatory compliance; data management and query resolution; document and SOP review; study document/plan development and review; maintenance and close-out of in-house site management activities; and clinical operations support activities and tasks.
For international roles, Longboard partners with local Employer of Record (EOR) Velocity Global to manage salary/benefits of international employees. Benefits are country-specific but generally include medical, vision, and dental insurance, parental leave, mental health support, and more.
Responsibilities include but may not be limited to:
This role will be based in Australia.
- Supports the global and regional clinical trial managers and trial leaders in the planning, execution, and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP, and applicable regulatory guidelines
- Performs an array of assigned duties including investigator site recruitment/feasibility; essential document collection and review; ICF review; study document/plan development and review; maintenance and close-out of in-house site management activities in accordance with the protocol; review and compliance with standard operating procedures (SOPs); ICH/GCP guidelines and all applicable regulatory requirements
- Assists in the review and approval of monitoring reports
- May conduct co-monitoring or observational visits at investigational sites
- Assists with the preparation and finalization of investigators’ contracts, budgets, and payments
- Obtain, review (to ensure completeness, accuracy, and regulatory compliance), and process essential regulatory, and administrative documents, and Informed Consent Forms (ICFs)
- Works with Technical Operations and/or CTAs to Initiate investigational product shipments as needed and ensures that supplies are adequate/appropriate for assigned studies and sites
- Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product), and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities
- Ongoing interaction with clinical operations team members and Investigator site staff to obtain and relay key study issues, status updates, and other study information to the clinical trial team and management
- Participates in the development and improvement of department processes, best practices, and tools and templates related to clinical trial management and operations
- Participates in the review and development of CRFs and CRF guidelines
- Performs in-house review of CRF data for completeness and accuracy, and resolves data management/query issues with study sites and vendors as needed
- Reviews data to identify protocol deviations and risks to subject safety/data integrity
- Works with CTAs to obtain licensing for study tools and assessments
- Evaluates the execution of the study protocol at the site level. Uses judgment and experience to evaluate the overall performance of site and site staff to provide recommendations regarding site-specific actions; immediately communicates/escalate serious issues to the study team
- Work with assigned CTAs and CROs to ensure study activities are documented via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and the Study Monitoring Plan
- Supports and monitors clinical trials to ensure sponsor and investigator obligations are met and in compliance with the currently approved protocol/amendment(s); applicable study procedures; applicable federal and local regulatory requirements; GCP; and company policy and procedures
- Supports the oversight of all activities listed and ensures all duties/documents/protocols/etc. meet Longboard’s expectations, and delivers them in accordance with the sponsor’s expectations, trial protocol, ICH/GCP guidelines, and applicable SOPs (local/US/international)
- Verifies that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents
- Performs other work-related duties as assigned or required
Minimum Requirements
- Bachelor’s degree, preferred
- 5+ years of relevant and progressive experience with clinical trials
- High level of proficiency in English (ideally English as a primary language)
- Have reliable home internet
- Can work a schedule that often includes early morning calls to communicate with the California headquarters
- Experience in all stages of clinical trial conduct (study start-up, maintenance, database lock, etc.) and a strong understanding of clinical trial processes, protocols, and medical terminology
- Prior experience in management and monitoring of CRO and investigative sites, preferred
- Experience with patient recruitment, non-compliance, safety, document management, an investigational product, IP accountability
- Strong written and verbal communication and computer literacy (e.g., Microsoft Word, Excel, PowerPoint, Outlook); strong experience utilizing CTMS, EDC, TMS, and related software
- Knowledge of ICH GCP, IRB/IEC, and local regulatory authority drug research & development regulations
- Motivated to work in a fast-paced, high-accountability environment
- Experience with bio-samples, storage of 3rd party data, and preferred
- Experience in Longboard’s focused therapeutic areas, preferred
- Travel up to 35%
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Clinical Research Associate – Longboard Pharmaceuticals, Inc. – Career Page (applytojob.com)
Job Title: Associate Director/Director, Clinical Line Management
Reporting To: VP, Clinical Operations
Department: R&D: Clinical Operations
People Manager: Yes
Location: Remote, based in Europe
Position Summary
The Associate Director/Director, Clinical Line Management will manage and oversee the human, material, system and fiscal resources to provide clinical in-house study management support services across studies and programs. The Associate Director/Director, Clinical Line Management will ensure that the assigned Clinical Research Associates (CRAs) gain the necessary skills to perform their respective job responsibilities and provide line management and oversight to ensure high quality and timely service and ensuring that processes are maintained in accordance with corporate and industry best practices that meet all regulatory requirements and guidelines. The Associate Director/Director, Clinical Line Management will interact with stakeholders in a way that fosters a culture of collaboration, innovation, and a positive working environment demonstrating a professional and supportive demeanor.
For international roles, Longboard partners with local Employer of Record (EOR) Velocity Global to manage salary/benefits of international employees. Benefits are country-specific but generally include medical, vision, and dental insurance, parental leave, mental health support, and more.
Responsibilities include but may not be limited to:
This role will be based in Europe.
- Team management in accordance with organization’ s policies and applicable regulations
- Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems
- Team engagement in accordance with Company Mission, Vision, and Values
- Approve actions on human resources matters
- Participate in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process
- Conduct onboarding training for new staff in conjunction with Human Resources
- Perform routine periodic review of training records as part of compliance oversight
- Identify opportunities for team’s skill enhancement, career growth, and continuous learning for professional development
- Ensure that staff have the proper resources, systems access, and training to complete job responsibilities
- Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable
- Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training
- Manage the quality of assigned staff’s clinical work through regular review and evaluation of work product. Obtain feedback from the study team managers on the CRA’s performance.
- Conduct on-site Accompanied Sponsor Oversight Visits (OSVs) with the CRA to assess and evaluate their proficiency in conducting SOVs, identify performance gaps, and provide feedback to improve training and enhance compliance with study protocols and regulatory standards
- Chair departmental and/or CRA team meetings to provide updates on best practices, team/company goals, continuing expectations and to engage in departmental decision-making
- Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff
- Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management
- Review and approve line reports’ leave requests, expense reports other administration
- Responsible for performance management of direct reports. Motivate, guide, coach and oversee direct reports for quality and guideline compliance. Identify areas for new training or skill checks and develop strategies to promote team member adherence to company procedures, standards and performance goals.
- May act as an CRA for a defined project or to assist with milestone achievement
- May participate in Clinical Operations quality or process initiatives, including development and/or implementation of tools to improve efficiency in the conduct of clinical studies/projects
- Provide feedback to the appropriate cross-functional team members and senior management, as applicable
Minimum Requirements
- Bachelor’s degree (BA/BS) in life sciences or equivalent college program is required, and commensurate experience in the clinical research industry is a plus
- 14+ years of experience in the pharmaceutical/biotechnology industry including 6+ years management experience
- Minimum of 5 years of RA or equivalent experience
- High level of proficiency in English (ideally English as a primary language)
- Have reliable home internet
- Can work a schedule that often includes early morning/late afternoon calls to communicate with the California headquarters
- Strong knowledge of FDA and ICH regulations
- Strong leadership and mentoring skills with experience in managing staff and ability to provide training and/or mentorship to colleagues on a 1:1 basis or meeting setting
- Strong knowledge of appropriate regulations and guidelines as they pertain to clinical monitoring and GCP
- Experience and thorough understanding of essential documents involved in the management of clinical trials and use of electronic TMF platforms for archiving of essential trial documents
- Developed or have participated in the development of SOPs, work instructions, guidance documents and tracking tools
- Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail
- Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members and direct reports
- Demonstrated leadership skills with an ability to work effectively within a team matrix as well as independently
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
- Proficiency with MS Office (e.g., Outlook, Word, Excel, PowerPoint, etc.)
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Job Title: Quality Systems Sr. Manager
Reporting To: VP, Head of QA
Department: Quality Assurance
People Manager: No
FLSA Status: Exempt
Location: La Jolla, CA
Schedule: Hybrid, 2-3 days a week in office
Position Summary
This position is an integral part of the Quality Assurance & Compliance function at Longboard Pharmaceuticals. The Quality Systems position will ensure appropriate and constant support and vigilance in the areas of GLPs, GCPs, and cGMP commensurate with domestic and international regulations and guidances, and internal Standard Operating Procedures.
This position manages the oversight of Quality Management systems such as deviations, CAPA, Quality Incidents, and document generation and change control. This role will support oversight of the quality of regulatory documentation in Veeva Quality Docs, Veeva TMF and Veeva QMS. This role will provide QMS input and drive quality principles, quality metrics, and GxP training compliance. The successful candidate will independently develop quality and compliance metrics to show the state of compliance and inspection readiness. This role is accountable for the routine execution of Quality Assurance Compliance duties related to Longboard’s drug development programs, as well as oversight of the continued development, implementation, maintenance, and performance of the GxP Quality Assurance systems both within Longboard and external vendors supporting Longboard activities.
Responsibilities include but may not be limited to:
- Ensuring that the Longboard Quality Management System is compliant with applicable Regulatory and Industry Standards, and internal procedures
- Participating in Quality System process activity across multiple functions including quality system projects and initiatives
- Periodic audits/review of Trial Master Files (TMFs) for ongoing trials to ensure accuracy and completeness
- Periodic audits of third-party contractors working on behalf of Longboard
- Conducting “Lookbacks” or gap analyses of existing Clinical Files supporting completed Longboard Clinical studies to determine accuracy and completeness
- Maintaining Quality Metrics to showcase areas of improvement and state of compliance
- Training cross-functional teams on pertinent use of QMS (Quality Incident, CAPA, Change Control, GxP Training, etc.)
- Formulating and executing strategies and roadmaps within the scope of Longboard’s Quality plans
- Collaborating closely with the Clinical Operations Team, Regulatory Affairs & CMC functions to provide expert quality assurance information, address identified issues, and drive continuous improvement
- Maintaining up-to-date knowledge of relevant regulatory requirements and ensuring congruency for the rest of the team
- Supporting the development and implementation of Standards, Processes, and Procedures.
- Preparing technical material, reports, and forms using a wide variety of text editing software and managing features (formatting, editing, deleting, updating, etc.).
- Review of QA department processes and make recommendations on these processes.
Minimum Requirements
- More than 7-10 years of Biotech/Pharma experience
- Must possess thorough knowledge of GxP regulatory requirements and guidelines
- Understanding of FDA and international regulations, and quality requirements
- Proficient in, MS Office, Veeva, SAP, SharePoint, Tableau
- Soft skills specific to team building and conflict resolution
- Excellent presentation, writing, verbal, and interpersonal skills
- Effectively influences actions and opinions of others. Ability to independently perform effectively and efficiently in a fast-paced environment.
- Ability to assess procedures, policies, work instructions, and site forms to improve processes and Quality Systems
- Ability to travel up to 15% of the time
- Ability to work constructively across all functions of the organization as well as with external customers
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $ 125,000.00 – $140,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
- Hybrid work schedule out of our La Jolla office, 2-3 days a week
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Quality Systems Sr. Manager – Longboard Pharmaceuticals, Inc. – Career Page (applytojob.com)
Job Title: Associate Field Scientific Director (FSD) Australia
Position Summary
The Associate FSD is an integral member of the Medical Affairs Team responsible for collaborating with Longboard and external stakeholders, disseminating medical information, and representing Longboard as a scientific expert. Your proactive approach and effective communication skills will contribute to Longboard’s success in advancing innovative therapies in neurology and rare diseases. The Associate Field Scientific Director, reporting to the Director Global Field Medical Affairs, will integrate their scientific expertise and knowledge to build lasting relationships and medical strategy for Longboard’s pipeline.
For international roles, Longboard partners with a local Employer of Record (EOR), Velocity Global, to manage payroll and benefits. Benefits are country-specific but generally include medical, vision, and dental insurance, parental leave, mental health support, and more.
Responsibilities include, but may not be limited to:
This role can be based anywhere in Australia, provided you are legally allowed to work in the country of residence without sponsorship.
- Execute field medical initiatives to support clinical development, patient advocacy, and other Longboard stakeholders for potential future product launches.
- Build, develop and maintain credible, scientific relationships with key external stakeholders to identify and address scientific and therapeutic needs.
- Support Phase III and future clinical trials by addressing specific needs as they are identified by Longboard’s Clinical Development Team.
- In collaboration with the Director GFMA, lead individual corporate projects as assigned.
- Collect and communicate insights and competitive intelligence to Longboard stakeholders.
- Maintain in-depth scientific, pharmaceutical, and clinical knowledge of relevant therapeutic areas.
- Represent Longboard as a scientific expert at scientific conferences, advisory boards, clinical investigator meetings, and patient advocacy group meetings.
- Partner with Longboard departments to ensure accurate external delivery of medical and scientific information.
- Collaborate with key Longboard stakeholders to represent Longboard’s interests externally.
- Provide education and dissemination of medical information externally to support clinical decision-making.
Minimum Requirements
- An advanced degree (PharmD, MD, DO, PhD or equivalent)
- 3+ years of experience in field medical affairs.
- High level of proficiency in English (ideally English as a primary language)
- Possess a thorough understanding of neurological and rare diseases.
- Knowledge of relevant local regulatory guidelines for interactions with healthcare professionals, compliance, and reporting.
- Proficient interpersonal abilities and adeptness in collaborating across cross-functional teams. Skilled at effectively conveying scientific information to both Longboard and external stakeholders, including thought leaders, advocacy groups, and managed care organizations.
- History of success in maintaining relationships with key health care professionals and staff (i.e., thought leaders, advocacy leaders, medical society leadership, payers, etc.).
- Understanding of local data privacy regulations and the importance of patient data privacy.
- Excellent communication (written and verbal), organization and collaboration skills.
- Familiarity with CRMs, Microsoft Office, and other software platforms relevant to the position.
- Ability to travel up to 60% of the time in Australia.
Preferred Experience
- Prior therapeutic areas experience in epilepsy.
- Familiarity with CLIA, LDT, AdvaMed Guidelines.
- Exhibits initiative-taking and resourcefulness.
- Experience with project management, leading development of tactics that align with medical strategy.
- Experience working on clinical trials.
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Reporting To: Global Clinical Program Lead
Department: R&D: Clinical Operations
People Manager: No
FLSA Status: Exempt
Location: Remote / In-house with 25% Travel
Position Summary
The Senior Clinical Trial Manager (Sr. CTM) provides oversight of the operational aspects of the planning, execution and completion of assigned Phase I through III clinical trials including: ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines. The Sr. CTM leads the cross-functional clinical trial team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to: CRO and vendor selection, contracting, and management; inspecting and monitoring CROs; clinical trial protocols and patient recruitment; system design and activation; risk mitigation plans and assessments; reporting and metrics; and safety events and reporting.
Responsibilities include, but may not be limited to:
- Leads the clinical operations team (CRAs and CTAs) and cross-functional clinical trial in all operational aspects of one or more pivotal studies from start-up to close-out; proactively identifies and resolves operational issues ensuring alignment of activities with study timelines, budgets, SOPs, GCP, and applicable regulatory guidelines
- Manages and provides day-to-day oversight of full service CROs and third-party vendors including identification and selection of CROs/vendors, set-up, logistics, and documentation
- Responsible for the trial level clinical operations budget, invoices, and change orders, including developing and managing Statements of Work (SOW), site budgets, investigator payments, CTAs, etc.
- Participates in investigational site feasibility activities and selection of investigative sites
- Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management
- Responsible for clinical trial material (CTM) label review and approval and assisting with CTM forecasting
- Develops and maintains study timelines, enrollment dashboards and status reports for senior management
- Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality, and data integrity; escalates study-related issues appropriately in a timely manner
- Manages and contributes to the development of clinical documentation including but not limited to study protocols, Informed Consent (ICF), Study Reference Binder, Study Management Plan, Monitoring plan, Pharmacy manual, Lab manual etc.
- Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product), and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities
- Participates in IRT, EDC, and ePRO design and user acceptance testing
- Oversees team engagement with CRO regarding clinical site oversight, data entry and cleaning timelines and assists with resolving site issues
- Participates and provides input to protocol, statistical analysis plan (SAP), tables, figures, data listings, protocol deviation reporting and clinical study report reviews
- Participates in data cleaning, data listing reviews and reconciliation and data analytics
- Contributes to and may lead the development of presentations for clinical sites, team and investigator meetings
- Responsible for oversight of study budget, investigator and vendor contracts, budgets, and payments
- Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit-ready
- Performs other work-related duties as assigned or required
- Demonstrates interpersonal versatility, able to simultaneously serve as an individual contributor and a leader
- Thinks strategically and tactically
- Ability to manage trial(s) independently with minimal oversight
- Assists with mentoring less experienced Clinical Trial Managers and Clinical Operations team members; assists with team development
Qualifications
- Bachelor’s degree
- 8+ years of relevant and progressive clinical trial management experience
- Experience in full-cycle drug development
- Global phase III clinical trial experience preferred
- Strong understanding of clinical trials processes, protocols, and medical terminology
- Strong experience utilizing CTMS, EDC, TMS, and related software
- Prior experience in management and monitoring of CRO and investigative sites
- Strong experience with patient recruitment, non-compliance, safety, document management, an investigational product, IP accountability, and budget management
- Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority drug research & development regulations
- Advanced experience with bio-samples, storage of 3rd party data
- Motivated to work in a fast-paced, high accountability environment
- Travel up to 25%
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La Jolla, CA is $160,000.00-$185,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
- Hybrid work schedule out of our La Jolla office, 2-3 days a week
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Job Title: Associate Field Scientific Director (FSD), Europe
Reporting To: Director, Global Field Medical Affairs
Department: R&D Management
People Manager: No
FLSA Status: Exempt
Location: Remote
Position Summary
The Associate FSD is an integral member of the Medical Affairs Team responsible for collaborating with Longboard and external stakeholders, disseminating medical information, and representing Longboard as a scientific expert. Your proactive approach and effective communication skills will contribute to Longboard’s success in advancing innovative therapies in neurology and rare diseases. The Associate Field Scientific Director, reporting to the Director Global Field Medical Affairs, will integrate their scientific expertise and knowledge to build lasting relationships and medical strategy for Longboard’s pipeline.
For international roles, Longboard partners with a local Employer of Record (EOR), Velocity Global, to manage payroll and benefits. Benefits are country-specific but generally include medical, vision, and dental insurance, parental leave, mental health support, and more.
Responsibilities include, but may not be limited to:
This role can be based anywhere in Europe, provided you are legally allowed to work in the country of residence without sponsorship.
- Execute field medical initiatives to support clinical development, patient advocacy, and other Longboard stakeholders for potential future product launches.
- Build, develop and maintain credible, scientific relationships with key external stakeholders to identify and address scientific and therapeutic needs.
- Support Phase III and future clinical trials by addressing specific needs as they are identified by Longboard’s Clinical Development Team.
- In collaboration with the Director GFMA, lead individual corporate projects as assigned.
- Collect and communicate insights and competitive intelligence to Longboard stakeholders.
- Maintain in-depth scientific, pharmaceutical, and clinical knowledge of relevant therapeutic areas.
- Represent Longboard as a scientific expert at scientific conferences, advisory boards, clinical investigator meetings, and patient advocacy group meetings.
- Partner with Longboard departments to ensure accurate external delivery of medical and scientific information.
- Collaborate with key Longboard stakeholders to represent Longboard’s interests externally.
- Provide education and dissemination of medical information externally to support clinical decision-making.
Minimum Requirements
- An advanced degree (PharmD, MD, DO, PhD or equivalent)
- 3+ years of experience in field medical affairs.
- High level of proficiency in English (ideally English as a primary language)
- Possess a thorough understanding of neurological and rare diseases.
- Knowledge of relevant local regulatory guidelines for interactions with healthcare professionals, compliance, and reporting.
- Proficient interpersonal abilities and adeptness in collaborating across cross-functional teams. Skilled at effectively conveying scientific information to both Longboard and external stakeholders, including thought leaders, advocacy groups, and managed care organizations.
- History of success in maintaining relationships with key health care professionals and staff (i.e., thought leaders, advocacy leaders, medical society leadership, payers, etc.).
- Understanding of local data privacy regulations and the importance of patient data privacy.
- Excellent communication (written and verbal), organization and collaboration skills.
- Familiarity with CRMs, Microsoft Office, and other software platforms relevant to the position.
- Ability to travel up to 60% of the time in Europe.
Preferred Experience
- Prior therapeutic areas experience in epilepsy.
- Familiarity with CLIA, LDT, AdvaMed Guidelines.
- Exhibits initiative-taking and resourcefulness.
- Experience with project management, leading development of tactics that align with medical strategy.
- Experience working on clinical trials.
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Job Title: Director, Data Management
Reporting To: EVP, Head of Operations
Department: R&D: Clinical Operations
People Manager: Yes
FLSA Status: Exempt
Location: Remote or Hybrid out of San Diego (2-3 days a week in office)
Position Summary
We are seeking a highly experienced Director of Data Management to lead our data management team in the planning, execution, and delivery of high-quality data for our research programs. The Director of Data Management will have a strong background in clinical data management and leadership experience. Reporting to the EVP, Head of Operations, this role will serve as a member of the clinical operations leadership team.
Responsibilities include but may not be limited to:
- Oversee data management activities at vendor from CRF/database development through database lock
- Collaborate with study team during protocol development with the duration of the program in mind to ensure the operational team is poised for successful data
- Accountable for database integrity and accuracy
- Ensure the completeness, accuracy, and consistency of data so that they meet the standards of quality expected for reporting to regulatory bodies.
- Assists in identifying and resolving data management issues on assigned studies
- Responsible for ensuring data management timelines are met within assigned studies
- May assist Biostatistics in development/review of Statistical Analysis Plans
- Reviews and resolves data discrepancies for standardized data validation systems and procedures, when applicable
- Supports data management requirements and deliverables for New Drug Application (NDA)/Marketing Authorization Application (MAA), including integrated databases
- Aids in production of quality data deliverables to support regulatory submissions, publications and due diligence activities
- Reviews clinical, regulatory and other documents, as needed, to assure data integrity and quality
- Oversees and manages final data management electronic Trial Master File (eTMF) for assigned studies
- Assists with the development of standards and process documentation, including Standard Operating Procedures
- Assures compliance with industry quality standards, guidelines and procedures
- Hire, train, coach and mentor all team members under him/her; set objectives and conduct performance reviews to foster growth of staff
- Responsible for department budget process and management
- Lead all DM activities including data collection forms (CRFs, diaries and CRF completion guidelines), clinical databases, study related data management documents, SOPs, etc.
- Adhere to FDA regulations (21 CFR Part 11, GCP), ICH guidelines and internal SOPs
- Interface with CRAs and other Clinical Operations team members to ensure the quality of data collection
Minimum Requirements
- Bachelor’s degree in Life Sciences, Mathematics or related field required
- 8-10 years of progressively responsible experience within the pharmaceutical, biotech or CRO industry
- Previous experience in clinical data management, including database set-up, data validation and consistency checks, initiation, and closure of trial databases, CRF design, query resolution, review and reporting of laboratory and safety data, coding, and SAE reconciliation or equivalent
- Knowledge of medical terminology
- Knowledge of coding dictionaries (Medical Dictionary for Regulatory Activities -MedDRA, WHO Drug)
- Excellent verbal and written communication skills as well as interpersonal and organizational skills
- Proficiency with data management systems and supporting statistical programs (e.g., SAS)
- Knowledge of database design and database concepts
- Proven skill at effectively leading a cooperative team effort and organizing resources to achieve team goals
- Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs
- Excellent written and oral communication skills, including experience with production of requirements documents, technical specifications, and other components of a clinical study database development process
- Highly detail-oriented
- Solid problem-solving and decision-making skills
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $200,000.00 – $220,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
- Hybrid work schedule out of our La Jolla office, 2-3 days a week or remote work
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Director, Data Management – Longboard Pharmaceuticals, Inc. – Career Page (applytojob.com)
Job Title: Senior Manager/Associate Director, Drug Safety Operations
Reporting To: Vice President, Global Regulatory Affairs
Department: R&D: Clinical Development
People Manager: No
FLSA Status: Exempt
Location: San Diego (hybrid) or remote
Position Summary
The Senior Manager/Associate Director, Drug Safety Operations will be responsible for oversight of safety operation activities with vendors and partners, including implementing safety reporting processes, monitoring compliance with internal standard operating procedures, overseeing adverse event case management, oversight of the drug safety database, providing support to study teams and projects. Reporting to the Vice President, Global Regulatory Affairs the Senior Manager/Associate Director, Drug Safety Operations will collaborate cross-functionally to support safety activities for clinical trials.
Responsibilities include but may not be limited to:
- Provide guidance and oversight of safety responsibilities outsourced to safety vendors
- Oversees/ensures safety case queries are resolved as per defined processes (interfacing with clinical operations team and clinical vendors, as required)
- Monitors performance and quality compliance (e.g. quality metrics, other reports) of the safety vendor and the quality output of the ICSRs; provides appropriate feedback and training
- Oversee case workflow (case receipt through submission) between safety vendor and Longboard
- Review incoming adverse events to determine the action required
- Manage preparation and processing of SAE/SUSAR reports activities for all investigational drugs
- Ensures safety cases are closed within required timelines with resolution of required queries
- Ensure corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs
- Operational oversight and execution of operational safety tasks for all clinical programs
- Supports safety data reconciliation activities and ensures safety vendor responsibilities are completed within the required timelines
- Oversee maintenance of safety database for tracking, storing, and reporting serious adverse events from all clinical trials.
- As required, present safety reporting processes according to study protocol at Investigator Meetings or to other required audience.
- Collaborate with partners on the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in Pharmacovigilance Agreements; Monitor partner compliance with partner Safety related activities as per agreement
- Responsible for UAT and Implementation of updates within Safety Database
- Oversee periodic MedDRA and WHO Drug upgrades
- Perform and manage SAE reconciliation between safety and clinical databases
- Collaborate with vendors for TMF Safety documents filing and review
- Contribute to preparation of relevant sections of clinical study reports, annual reports (e.g. DSUR), aggregate reports, expedited safety reports and other regulatory documents
- oOversee submission activities for DSUR, ICSRs and aggregate reports
- Author and maintain SOPs as applicable
Minimum Requirements
- Bachelor’s degree in Life Sciences, Healthcare, or relevant field, advanced degree preferred
- 5-8 years of progressive experience working in Drug Safety
- Knowledge of and experience with international regulatory adverse event reporting requirements
- Hands-on experience with adverse event case processing
- Experience with Safety Databases (Argus, ArisG or other)
- Previous clinical healthcare experience (e.g. nursing) a plus
- Excellent interpersonal communication skills and ability to work effectively as part of a team
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $150,000.00-$180,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
- Hybrid work schedule out of our La Jolla office, 2-3 days a week
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK:
Reports To: Director, Clinical Line Management
Department: R&D: Clinical Operations
People Manager: No
FLSA Status: Exempt
Location: San Diego, CA
Schedule: Hybrid (2-3 days a week) out of San Diego office
Position Summary
The Clinical Research Associate (CRA) supports global and regional clinical trial managers and trial leaders in the planning, designing, executing, monitoring, and reporting of clinical trials. The In-House Clinical Research Associate partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, but not limited to, essential document collection and review; investigative site recruitment & feasibility; FDA/GCP/ICH and regulatory compliance; data management and query resolution; document and SOP review; study document/plan development and review; maintenance and close-out of in-house site management activities; and clinical operations support activities and tasks.
Responsibilities include but may not be limited to:
- Supports the global and regional clinical trial managers and trial leaders in the planning, execution, and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP, and applicable regulatory guidelines
- Performs an array of assigned duties including investigator site recruitment/feasibility; essential document collection and review; ICF review; study document/plan development and review; maintenance and close-out of in-house site management activities in accordance with the protocol; review and compliance with standard operating procedures (SOPs); ICH/GCP guidelines and all applicable regulatory requirements
- Assists in the review and approval of monitoring reports
- May conduct co-monitoring or observational visits at investigational sites
- Assists with the preparation and finalization of investigators’ contracts, budgets, and payments
- Obtain, review (to ensure completeness, accuracy, and regulatory compliance), and process essential regulatory, and administrative documents, and Informed Consent Forms (ICFs)
- Works with Technical Operations and/or CTAs to Initiate investigational product shipments as needed and ensures that supplies are adequate/appropriate for assigned studies and sites
- Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product), and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities
- Ongoing interaction with clinical operations team members and Investigator site staff to obtain and relay key study issues, status updates, and other study information to the clinical trial team and management
- Participates in the development and improvement of department processes, best practices, and tools and templates related to clinical trial management and operations
- Participates in the review and development of CRFs and CRF guidelines
- Performs in-house review of CRF data for completeness and accuracy, and resolves data management/query issues with study sites and vendors as needed
- Reviews data to identify protocol deviations and risks to subject safety/data integrity
- Works with CTAs to obtain licensing for study tools and assessments
- Evaluates the execution of the study protocol at the site level. Uses judgment and experience to evaluate the overall performance of site and site staff to provide recommendations regarding site-specific actions; immediately communicates/escalate serious issues to the study team
- Work with assigned CTAs and CROs to ensure study activities are documented via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and the Study Monitoring Plan
- Supports and monitors clinical trials to ensure sponsor and investigator obligations are met and in compliance with the currently approved protocol/amendment(s); applicable study procedures; applicable federal and local regulatory requirements; GCP; and company policy and procedures
- Supports the oversight of all activities listed and ensures all duties/documents/protocols/etc. meet Longboard’s expectations, and delivers them in accordance with the sponsor’s expectations, trial protocol, ICH/GCP guidelines, and applicable SOPs (local/US/international)
- Verifies that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents
- Performs other work-related duties as assigned or required
Minimum Requirements
- Bachelor’s degree, preferred
- 5+ years of relevant and progressive experience with clinical trials
- Experience in all stages of clinical trial conduct (study start-up, maintenance, database lock, etc.) and a strong understanding of clinical trial processes, protocols, and medical terminology
- Prior experience in management and monitoring of CRO and investigative sites, preferred
- Experience with patient recruitment, non-compliance, safety, document management, an investigational product, IP accountability
- Strong written and verbal communication and computer literacy (e.g., Microsoft Word, Excel, PowerPoint, Outlook); strong experience utilizing CTMS, EDC, TMS, and related software
- Knowledge of ICH GCP, IRB/IEC, and local regulatory authority drug research & development regulations
- Motivated to work in a fast-paced, high-accountability environment
- Experience with bio-samples, storage of 3rd party data, and preferred
- Experience in Longboard’s focused therapeutic areas, preferred
- Travel up to 35%
About Longboard
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $130,000.00 – $150,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
- Hybrid work schedule out of our La Jolla office, 2-3 days a week
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
TO APPLY PLEASE CLICK ON THE FOLLOWING LINK: