LONGBOARD LIFE

We are committed to improving the quality of life for individuals with devastating neurological conditions and strive to be the best possible teammates and colleagues. We are looking for people to join our team who are just as dynamic, talented, and passionate as we are.

Open Positions

Longboard Pharmaceuticals is an equal-opportunity employer offering competitive benefits. Our open positions are listed below. To apply, please send your CV to [email protected] with the position you are applying for in the subject line.

If the position you are looking for is not listed, please check back frequently for new open positions as our team is growing rapidly.

Job Title: Vice President, Head of Clinical Pharmacology
Reports To: Chief Medical Officer
Department: R&D
Department Code: 3010
People Manager: Yes
FLSA Status: Exempt
Location: Remote or Hybrid

Summary

The Vice President of Clinical Pharmacology will be responsible for the design, leadership, and implementation of Clinical Pharmacology and Modeling & Simulation strategies across Longboard’s development programs. This individual will work in close collaboration with colleagues in Clinical Development, Clinical Operations, Biostatistics, Non-clinical Development, Bioanalysis, Medical Affairs, Project Management, Research, Technical Operations, and Regulatory to execute the company’s overall development strategy, participate on cross-functional project teams, and lead interactions with global health authorities. S/he will also play a key role in building the Clinical Pharmacology function and capabilities at Longboard. To be successful in this leadership role, the individual will have demonstrated management skills, be self-motivated, able to work well in cross-functional teams, and must have a strong work ethic and integrity. Additionally, the individual must possess outstanding communication skills (both verbal and written) and be able to build relationships and influence decision-making, while managing to tight timelines.

Responsibilities

  • Responsible for the Clinical Pharmacology function and capabilities, through the recruitment and training of clinical pharmacologists and management of contractors.
  • Design, implement, and lead the clinical pharmacology and modeling & simulation strategies and plans for Longboard development compounds from pre-IND and first-in-human testing through later phases of clinical development, including pivotal Phase 2/3 studies and global regulatory submissions.
  • Develop clinical pharmacology study designs and help prepare study protocols and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines.
  • Collaborate with Clinical Operations to oversee, contract, and manage clinical pharmacology studies.
  • Leadership and participation on cross functional teams as clinical pharmacology expert to ensure proper integration of these activities into overall project plans.
  • Contribute to the analysis of data, including hands-on or externally contracted PK/PD data analysis and advanced modeling and simulation, from nonclinical and clinical studies.
  • Write, edit, and finalize sections of regulatory documents, and interact with global health authorities as needed.
  • Interpret, summarize, and present data to internal project teams, senior management, and external partners/organizations.
  • Contribute to departmental processes such as SOP’s, operational support, templates, etc.
  • Maintain a current understanding of regulatory guidance, relevant literature and methodologies, as well as the scientific literature related to specific Longboard pipeline programs.

Qualifications

  • Ph.D. in Pharmacokinetics, Mathematics, Pharmacology, or related scientific discipline required,with 15+ years of biotech/pharmaceutical drug development experience.
  • Expertise in small molecule clinical pharmacology.
  • Regulatory experience required, such as IND/CTA filings and/or NDA/MAA/PMDA submissions.
  • Prior experience leading all aspects of Clinical Pharmacology for an early-stage small molecule program, including pivotal trial design, Health Authority interactions, NDA/MAA filings, label negotiations, approval, and commercialization.
  • Extensive experience in biopharmaceutics required. This individual will work in close collaborations with colleagues and vendors in Technical Operations to develop formulation strategies and PK bridging strategies to support molecule progress.
  • Experience required in leading the design and/or analysis of clinical pharmacology studies (e.g., relative bioavailability, drug-drug interaction, special populations – hepatic and renal impairment, pediatric, human ADME, etc.
  • Hands-on experience with clinical PK and PK/PD data analysis required (e.g., Phoenix WinNonlin); hands-on experience with advanced modeling and simulation (e.g., Pop PK, PBPK) strongly preferred.
  • Experience with outsourcing, overseeing, and managing clinical pharmacology and/or modeling & simulation activities at vendors preferred.
  • Familiarity with ICH/FDA/EMA guidelines for the conduct of clinical pharmacology studies to support regulatory filings
  • Required experience in authoring regulatory submissions, as well as multiple INDs and preparing detailed science-based responses to regulatory questions.
  • Ability to multi-task and change quickly to changing priorities
  • Strong written and oral communication skills and a track record of achievement in publications
  • Ability to work collaboratively within cross-functional teams
  • Prior management experience required; some prior experience in helping to build a clinical pharmacology department is strongly preferred.

Job Title: Senior Clinical Trial Manager
Department: R&D: Clinical Operations
Reports To: V.P., Head of Operations
FLSA Status: Exempt
Location: San Diego or Remote

Summary

The Senior Clinical Trial Manager (Sr. CTM) provides oversight of clinical trials according to all applicable regulations and guidance, ICH/GCP, and SOPs. 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

  • Leads the clinical operations team (CRAs and CTAs) and cross-functional clinical trial team in the planning, execution, and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP, and applicable regulatory guidelines
  • Responsible for clinical trial material (CTM) label review and approval and assisting with CTM forecasting
  • 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
  • Obtain and relay key study issues, status updates, and other study information to the clinical trial team and management
  • Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management
  • 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
  • Provides input on the development of eCRF design
  • Participates in IRT, EDC, and ePRO user acceptance testing
  • Participates in data cleaning, listing, and report output reviews
  • Develops, reviews, and approves study-related manuals, plans, specifications, charters, newsletters, and materials
  • Participates in protocol deviation listing reviews and meetings
  • Responsible for oversight of study budget, investigator and vendor contracts, budgets, and payments
  • Participates in the protocol, table, figure, data listings, and clinical study report reviews
  • Provides input/reviews DSUR, PSUR, and regulatory annual and periodical reports
  • Develops presentations for clinical sites, team and investigator meetings
  • Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit-ready
  • May be responsible for a defined region, vendor, or process across a program
  • May have functional reporting responsibilities
  • 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
  • Leads through influence with the ability to manage and mentor internal personnel and external resources
  • Participates in the identification and selection process for CROs and vendors
  • Provides input on protocol design and statistical analysis plan (SAP)
  • Mentors 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
  • 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%

At Longboard, we believe benefits are an important part of our employees’ overall compensation and well-being. We are pleased to offer a comprehensive array of valuable benefits to protect the health of our employees, their families and their way of life.

Our benefits currently include:

  • Medical Plan (90% of premium paid by company)
  • Dental Plan (90% of premium paid by company)
  • Vision Plan (90% of premium paid by company)
  • Life and AD&D (no cost to employee for basic coverage)
  • Short-Term Disability – Long-Term Disability – Cost of Benefits
  • 401(k) Plan, including company match with immediate vesting
  • Paid Time Off, including one week off in the summer and one week off around December holidays
  • Longboard Perks (gym, garage parking, company-sponsored events, etc.)

Our Employees

“I was really excited to join Kevin early on at Longboard where we are focused on improving the lives of patients with devastating neurological conditions. We are building a team that is passionate and talented, as well as fun, diverse and inclusive. With team members across the United States, we foster an environment of collaboration where we thrive together, challenge each other to do better and strive to make a difference in each other’s lives as well as the lives of patients.”

Brandi Roberts
Chief Financial Officer

“At Longboard we are creating a culture that values different opinions and approaches to problem solving with an open collaboration across all levels of the organization. I am thrilled to join the company at an early stage so I can openly engage with every employee to learn what motivates them and to help them to succeed and enjoy their journey with Longboard.”

Jennifer Patterson
Director, Human Resources

Live the
Longboard Life.

We are committed to improving the quality of life for individuals with devastating neurological conditions and strive to be the best possible teammates and colleagues. Learn more about our culture, benefits and open positions.

We show up
for patients.

The people living with, supporting and treating those with neurological conditions are at the center of what we do. Learn more about our commitment.