Responsibilities:
- Support design and execution of assigned clinical trial(s) with cross-functional study teams.
- Serve as primary medical/safety contact for assigned trials; ensure compliance and patient safety; clarify protocol interpretation for investigators and internal/external teams.
- Partner with Clinical Science, Data Management, and Statistical Programming to ensure data integrity; lead data reviews and insight generation to guide development strategy.
- Collaborate with Safety on reporting AEs/SAEs; contribute to safety profile characterization and risk mitigation plans.
- Integrate preclinical, pharmacology, translational, and clinical data to generate actionable development insights; assess benefit-risk profiles for complex decisions.
- Author key study and regulatory documents (e.g., protocol, investigator brochure, informed consent, clinical study reports) and contribute to scientific publications.
- Represent the study/program with key internal/external stakeholders; lead/present at investigator meetings and advisory committees.
- Maintain oncology scientific/clinical knowledge; provide input into pipeline and translational/preclinical work.
Required qualifications:
- M.D. (or equivalent).
- 3+ years in biotech/pharma oncology drug development (or substantial clinical investigator experience if not meeting industry requirement).
- cGCP knowledge; clinical trial design and global drug development process understanding.
- Knowledge of current regulatory environment (e.g., FDA/EMA).
- Independent judgment; strong interpersonal, verbal communication, influencing, analytical, and presentation skills.
- Ability to cultivate stakeholder relationships; work in fast-paced biotech environment; travel up to 20%.
Preferred qualifications:
- Board-certified in oncology; early phase drug development experience; translational science knowledge.
Compensation/benefits:
- Base salary range: $250,000β$310,000; eligible for annual bonus, equity compensation, and competitive benefits package.