JOB SUMMARY
We are seeking a
Senior or Executive Medical Director to provide medical and clinical development leadership for our early-stage oncology portfolio. This individual will own the clinical strategy and execution for one or more assets from IND-enabling activities through first-in-human and early efficacy studies. You will serve as the clinical and scientific lead on cross-functional program teams, working closely with our discovery, translational, regulatory, and clinical operations groups - and directly alongside our AI/ML platform teams - to translate novel candidates into well-designed clinical programs.
This position will be based in our San Diego Headquarters.
Title and scope will be calibrated to the successful candidate's experience.
KEY RESPONSIBILITIES
- Serve as the clinical/medical lead for early-stage oncology programs, owning the clinical development strategy from IND through Phase 1 and early proof-of-concept.
- Author and drive the clinical components of IND submissions, including protocols, investigator's brochures, and clinical sections of regulatory documents; support and participate in health authority interactions (e.g., pre-IND, EOP1).
- Design first-in-human and early-phase oncology trials, including dose-escalation and dose-optimization strategies, biomarker and translational plans, and eligibility criteria.
- Provide ongoing medical monitoring and safety oversight for active trials, including review of emerging safety data, dose decisions, and management of study conduct in partnership with Clinical Operations and Pharmacovigilance.
- Partner with translational science and the AI/ML platform teams to define patient selection strategies, pharmacodynamic endpoints, and data-driven development hypotheses.
- Engage key opinion leaders, investigators, and study sites; represent programs to internal governance, partners, and, as appropriate, external stakeholders.
- Collaborate cross-functionally with Regulatory Affairs, CMC, Clinical Operations, Biostatistics, and Program Management to keep programs on strategy and on timeline.
- Contribute to portfolio-level decisions, candidate selection input, and business development / due diligence as needed.
QUALIFICATIONS
- M.D. or D.O. (or international equivalent); board eligibility/certification in hematology/oncology or medical oncology strongly preferred; exceptional candidates with PharmD and relevant oncology and clinical experience will be considered
- Meaningful drug-development experience in biotech or pharma. We anticipate roughly 5+ years for a Senior Medical Director and 8-10+ years for an Executive Medical Director; strong candidates across this range are encouraged to apply.
- Direct, hands-on experience authoring and executing IND submissions.
- Direct experience designing and running Phase 1 / early-phase oncology clinical trials.
- Demonstrated experience with oncology assets and a strong understanding of the oncology therapeutic and drug-development landscape.
- Working knowledge of GCP, ICH guidelines, and the global regulatory environment for oncology development.
PREFERRED QUALIFICATIONS
- Experience with small-molecule oncology programs and targeted therapies.
- Experience taking a program from candidate nomination or IND through clinical proof-of-concept.
- Comfort working in a fast-paced, data-rich, technology-forward environment and collaborating with computational and platform teams.
- Prior experience presenting to health authorities and/or supporting BD due diligence
PAY AND BENEFITS
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
