Senior Medical Director

Responsibilities

• Serve as the primary Medical Monitor for assigned clinical trials.
• Provide ongoing medical oversight to ensure patient safety and protocol compliance.
• Review eligibility queries, protocol deviations, and safety data in real time.
• Collaborate with Safety/Pharmacovigilance on SAE review, signal detection, and benefit-risk assessments.
• Support investigator communications and training related to medical and safety matters.

Data Review & Quality Oversight

• Lead ongoing clinical data review to ensure integrity, completeness, and scientific validity.
• Partner with Clinical Operations and Data Management to ensure high data quality standards.
• Identify data trends, inconsistencies, and potential safety or efficacy signals.
• Contribute to statistical analysis planning and interpretation of study results.
• Ensure readiness for database lock and regulatory submissions.

Cross-Functional Clinical Development Leadership

• Provide strategic guidance across functions to optimize trial design, recruitment, and execution.
• Contribute to translational and biomarker strategies.
• Collaborate cross-functionally on briefing documents, INDs, NDAs/BLAs, and agency interactions.
• Lead medical communications including abstracts, manuscripts, and congress presentations.

Qualifications

• M.D. degree or PA/NP/PhD
• 2+ years as a clinical scientist or medical director in the biotech or pharmaceutical industry.
• Prior experience serving as a Medical Monitor for interventional clinical trials.
• Experience in clinical data review and ensuring data quality.
• Experience leading cross-functional clinical development teams.
• Experience with regulatory authority interactions is preferred.
• Strong communication, ownership and decision-making skills.
• Common sense and flexibility.

Compensation

Compensation Range: $325,000 - $400,000 (actual compensation may vary based on experience, qualifications and location)

Benefits

• Competitive salary and equity in a well-funded, clinical-stage biotech
• 100% remote work and flexible schedule
• Health, dental, and vision for you and your dependents
• Flexible time off
• Generous parental leave
• Traditional and Roth 401k

About the Role

We are a small, focused team where every person has direct impact — united by a shared commitment to care deeply, create boldly, and never stop learning.