Clinical Science Director – Biotech Oncology

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

📋 Description

• Design, strategize, and execute early- and/or late-phase clinical oncology trials.

• Prepare and draft clinical development documentation, such as study synopses and protocols.

• Summarize findings from studies for various documents and publications.

• Provide scientific insights and progress reports to project teams.

• Develop, prepare, and initiate study protocols along with necessary documentation in alignment with project plans, federal regulations, GCP, and best medical practices.

• Engage with oncology investigators and thought leaders to assist in the creation of clinical synopses and protocols.

• Research and aid in the selection of investigators for clinical trials.

• Conduct literature reviews for assigned clinical product candidates.

• Create 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.

• Take part in internal safety meetings, analyzing and reporting potential safety events.

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

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

• Offer insights on emerging clinical and competitive trends.

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

• Deliver scientific presentations regarding Exelixis investigational agents to physicians and external stakeholders.

• Provide clinical education support for internal Exelixis personnel.

• Maintain clinical and technical knowledge in the field of oncology.

⛳️ Requirements

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

• 5-8 years of clinical development experience in the biotechnology or pharmaceutical sector, or a comparable blend of academic and industry experience.

• Experience in clinical oncology studies involving molecular targeted or immunological therapies.

• In-depth knowledge of clinical trial execution and the drug development lifecycle.

• Proven track record in designing, executing, and reporting clinical trials in oncology with both small and large molecule drug candidates.

• Ability to identify and implement strategies and procedures to ensure high-quality outcomes.

• Strong analytical abilities coupled with effective business communication skills.

• Highly organized, capable of working within tight deadlines.

• Proficient public speaking and presentation skills.

• Ability to exercise discretion within broadly defined practices and policies.

• Capability to resolve complex issues using professional concepts alongside company policies and procedures.

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

🏝️ Benefits

• 401k plan with generous contributions from the company.

• Comprehensive group medical, dental, and vision coverage.

• Life and disability insurance provided.

• Flexible spending accounts available.

• Discretionary annual bonus program in place.

• Opportunity to acquire company stock.

• Long-term incentive options.

• 15 accrued vacation days during the first year.

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

• Up to 10 sick days available throughout the calendar year.

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