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.

There are no open positions 

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.