Clinical Science Director

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

📋 Description

• Design, plan, and execute both early- and late-phase clinical oncology studies.

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

• Summarize study outcomes for documentation and publications.

• Provide scientific information and progress updates to project teams regarding assigned clinical studies.

• Create, prepare, and implement study protocols and necessary documentation in accordance with project plans, federal regulations, GCP, and good medical practices.

• Collaborate with oncology investigators and thought leaders to enhance clinical synopses and protocols.

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

• Conduct literature research for assigned clinical product candidates.

• Develop Informed Consent Forms, Case Report Forms, and CRF instructions in collaboration with clinical operations and internal study teams.

• Act as the clinical study team contact for medical monitor inquiries, providing guidance and oversight.

• Create agendas, training materials, and presentations for site visits, investigator meetings, and other study-related events.

• Participate in internal safety meetings and analyze and report potential safety events.

• Review and interpret study data for health authority reports, regulatory filing documentation, and study close-out reports.

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

• Provide insights on emerging clinical and competitive trends.

• Coordinate and manage clinical oncology studies while fostering relationships with study investigators.

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

• Offer clinical education support for internal Exelixis personnel.

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

⛳️ Requirements

• Pharm.D., PhD, 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 mix of academia and industry.

• Involvement in clinical oncology studies focused on molecular targeted or immunological therapies.

• Extensive and comprehensive knowledge of clinical trial implementation and the drug development process.

• Experience in the design, execution, and reporting of oncology clinical trials involving both small and large molecule drug candidates.

• Strong analytical skills and effective business communication abilities.

• Highly organized with the capability to operate under strict timelines.

• Proficient public speaking and presentation skills.

• Aptitude for tackling complex problems requiring thorough evaluation of various factors.

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

• Competence in applying professional concepts and company policies to resolve challenging issues.

• Capacity to network with key contacts beyond personal areas of expertise.

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

🏝️ Benefits

• 401k plan with substantial company contributions.

• Group medical, dental, and vision insurance.

• Life and disability coverage.

• Flexible spending accounts.

• 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 available throughout the calendar year.

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

• Support for disability accommodation.