Emerging San Francisco, CA Biopharma - late-stage clinical company, rare disease, neurodegenerative disease pipeline
The Director or Sr. Director, Clinical Trial Management will lead the execution of one or more clinical programs, ensuring high quality clinical trials are conducted on time and within budget. This individual will have line management responsibilities.
- Maintains accountability for the successful delivery of clinical program(s) from study planning to close-out
- Manages all financial aspects of the clinical program(s). Negotiates vendor contracts, ensuring clarity in contracts and budgets, and oversees vendor performance to contract and agreed budget.
- Oversees the integrated study timelines, ensuring close coordination between the study team and external parties.
- Ensures clinical trials are conducted in compliance with Good Clinical Practice, local regulations, study protocols, and SOPs
- Ensures that risks to timelines, budgets, or quality are identified proactively, communicated effectively, and mitigated appropriately.
- Leads Clinical Operations team to deliver on operational aspects of clinical trials, including site and vendor selection and oversight, study project management, and Trial Master File management
- Oversees the development of fit-for-purpose operational plans (e.g., Monitoring Plan, TMF Plan) and leads team to conduct trial activities in accordance with agreed plans
- Maintains strategic business partnerships with CROs, vendors, key opinion leaders, and investigative sites
- Works in partnership with key internal functions including, but not limited to Finance, Legal, Regulatory, Biometrics, Clinical Development, and Medical Affairs
- Develop and maintain project and functional budgets and timelines and ensure delivery and execution within agreed parameters
- Participates in functional budget planning and SOP / process development, as needed
Education and/or Experience
- Bachelor’s degree in scientific discipline required; master’s degree or higher preferred
- At least 12 years’ experience in clinical operations in biotech / pharma companies and/or CRO
- Experience managing neuroscience, oncology, or rare disease clinical trials
- Strong experience managing Phase 1-3 multinational clinical trials, including successful management of cross-functional teams
- In-depth experience with vendor and site selection, contracts and budgeting, and vendor and site oversight
- Demonstrated expertise in Good Clinical Practice and experience with sponsor regulatory inspection(s)
- Working knowledge of translational science, regulatory operations, biometrics, pharmacovigilance, and medical monitoring
- Experience managing direct reports, including hiring, performance management, and development
- Willingness to be an individual contributor or hands-on team leader, according to project demands
Competencies and Attributes
- Demonstrated leadership to drive results that are needed to achieve company objectives
- Excellent written and verbal communication skills
- Skilled in setting and driving operational strategy
- Strong people leadership skills