Lead oncology clinical development for an active trial program, with responsibility for medical monitoring, protocol development, and study leadership across the full trial lifecycle. This role also contributes to broader strategy, including site selection, data outputs, publications, and interaction with regulators and external partners. The work is highly cross-functional and centers on translating clinical and scientific input into efficient, well-run development programs.
Key Responsibilities
- Conduct medical monitoring and provide study leadership for one or more oncology clinical trials across early- to late-stage development.
- Define clinical study protocols and contribute to trial design, start-up, execution, analysis, and reporting.
- Collaborate with clinical operations, regulatory affairs, translational science, drug safety, biostatistics, and program management teams.
- Coordinate interactions with health agencies, vendors, CROs, consultants, and co-development or licensing partners.
- Recommend clinical trial sites, investigators, key data outputs, and publications.
- Use scientific and clinical expertise to support development strategy and improve the standard of care for target oncology indications.
- Participate in governance discussions, resolve project issues, and help keep programs aligned to budget and timelines.
- Represent the program in meetings with regulatory authorities and other external stakeholders.
Required
- Medical degree (MD or DO).
- Completed residency and fellowship in oncology.
- At least 5 years of relevant post-graduate experience in biotech, pharmaceutical, academic, or medical research settings.
- Experience in hematology or oncology.
- Experience with oncology drug development, including pre-clinical and clinical programs.
- Experience with IND, CTA, and full dossier review, filing, and defense.
- Experience working in a regulated environment with GCP and GLP exposure.
- U.S. work authorization.
Preferred
- Industry experience in biotech or pharmaceutical drug development.
- Experience in cell therapy.
- Experience evaluating and managing CROs and other vendors within budget.
- Experience with regulatory inspection readiness.
Benefits & Perks
- Annual performance bonus.
- Equity compensation.
- Health insurance.
- Generous time off, including two annual company-wide holiday shutdowns.
- Collaborative, cross-functional work environment.
- Opportunity to work remotely if suitable, with frequent travel to the South San Francisco or Los Angeles office.
- Expected salary range of $255,000 to $335,000 per year.