The Senior Medical Director will provide strategic and operational medical leadership across the clinical development lifecycle. This individual will serve as the medical monitor and cross-functional medical lead for assigned programs, ensuring scientific rigor, patient safety, and high-quality data generation while working collaboratively to execute efficiently and successfully. This is a lead role in a small, fast-paced biotech where there will be significant opportunities for creativity, problem-solving and contributing to a range of cross-functional activities.
Reports to: Chief Medical Officer
Location: Remote (U.S.)
ResponsibilitiesMedical Monitoring- 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 Range: $325,000 - $400,000 (actual compensation may vary based on experience, qualifications and location)
Working at FaethBenefits:
- 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
- Mission oriented, remote first culture
