Clinical Science Director – Biotech Oncology

This is a fully remote position, open to applicants in California.

📋 Description

• Design, plan, and execute clinical oncology studies in both early and late phases.

• Prepare and write clinical development documents, such as study synopses and protocols.

• Summarize study findings for documentation and publication purposes.

• Provide scientific information to project teams and offer updates on the progress of assigned studies.

• Create, prepare, and implement study protocols and necessary documentation while adhering to project plans, federal regulations, GCP, and best medical practices.

• Collaborate with oncology investigators and thought leaders to aid in the development of clinical synopses and protocols.

• Conduct research and assist in the selection of investigators.

• Perform literature research for designated clinical product candidates.

• Work together on Informed Consent Forms, Case Report Forms, and instructions for CRFs.

• Assist medical monitors with inquiries, providing guidance and oversight.

• Develop agendas, training materials, and presentations for site visits and investigator meetings.

• Engage in internal safety meetings and analyze/report potential safety events.

• Review and interpret study data for health authority reports, regulatory submissions, and study closure reports.

• Write and/or review product-specific abstracts and publications, and support presentations at scientific meetings.

• Offer insights on emerging clinical and competitive trends.

• Coordinate and facilitate clinical oncology studies while nurturing relationships with investigators.

• Deliver scientific presentations regarding Exelixis investigational agents to healthcare professionals and external clients.

• Provide clinical education support for internal stakeholders at Exelixis.

• Maintain expertise in clinical and technical oncology.

⛳️ Requirements

• Pharm.D., PhD, or M.D. with a minimum of 8 years of relevant experience; or a comparable combination of education and experience.

• 5-8 years of clinical development experience within the biotechnology or pharmaceutical sectors, or an equivalent mix of academia and industry experience.

• Involvement in clinical oncology studies that utilize molecular targeted or immunological therapies.

• Extensive and thorough understanding of clinical trial execution and the drug development process.

• Proven experience in designing, conducting, and reporting on clinical trials in oncology, utilizing both small and large molecule drug candidates.

• Excellent analytical skills alongside strong business communication capabilities.

• Highly organized and capable of managing work under tight deadlines.

• Competent public speaking and presentation skills.

• Willingness to travel 10-25% of the time.

🏝️ Benefits

• 401k plan featuring generous contributions from the company.

• Comprehensive group medical, dental, and vision coverage.

• Life and disability insurance options.

• Flexible spending accounts available.

• Discretionary annual bonus program.

• Opportunity to purchase company stock.

• Long-term incentive plans.

• 15 accrued vacation days in the first year.

• 17 paid holidays, including a company-wide winter shutdown in December.

• Up to 10 sick days throughout the calendar year.

• Provision of necessary equipment, such as dual monitors and ergonomic chairs.