This job is closed
We regret to inform you that the job you were interested in has been closed. Although this specific position is no longer available, we encourage you to continue exploring other opportunities on our job board.
Clinical Science Director
Exelixis - King of Prussia, PA
posted about 2 months ago
About the position
The Clinical Science Director plays a pivotal role in the design, planning, and development of clinical studies in oncology, collaborating with clinical and project teams. This position involves preparing clinical development documents, summarizing study results, and providing scientific support to project teams. The director will interact with investigators, conduct literature research, and ensure compliance with regulations while facilitating the execution of clinical trials.
Responsibilities
- Design, prepare, and initiate study protocols and documentation in compliance with project plans and regulations.
- Interact with investigators and thought leaders in oncology to facilitate clinical study designs.
- Research and assist in the selection of investigators for clinical studies.
- Conduct literature research for assigned clinical product candidates.
- Collaborate with clinical operations to develop Informed Consent Forms and Case Report Forms.
- Act as a contact for medical monitor inquiries with guidance from the Medical Monitor.
- Develop agendas and training materials for site visits and investigator meetings.
- Participate in internal safety meetings and report potential safety events.
- Collaborate in the clinical review and interpretation of study data for regulatory reports.
- Contribute to writing and reviewing product-specific abstracts and publications.
- Deliver scientific presentations on investigational agents to external customers.
- Provide clinical education support for internal customers.
- Maintain clinical and technical expertise in oncology.
Requirements
- Pharm.D., PhD, or M.D. with a minimum of 8 years of related experience, or equivalent combination of education and experience.
- 5-8 years of clinical development experience in the biotechnology or pharmaceutical industry or equivalent academia and industry experience.
- Experience in clinical oncology studies with molecular targeted or immunological therapies.
- Comprehensive knowledge of clinical trial implementation and drug development processes.
- Experience in designing, executing, and reporting clinical trials in oncology.
Nice-to-haves
- Strong analytical and business communication skills.
- Good public speaking and presentation skills.
- Ability to work under tight timelines.
Benefits
- 401k plan with generous company contributions
- Group medical, dental, and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in the first year
- 17 paid holidays including a company-wide winter shutdown
- Up to 10 sick days throughout the calendar year
