Faeth Therapeutics
The Senior Medical Director provides strategic and operational medical leadership throughout the clinical development lifecycle, serving as the medical monitor and cross-functional medical lead for assigned programs. This role ensures scientific rigor, patient safety, and high-quality data generation while collaborating across functions to execute clinical trials efficiently and successfully.
Key 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.
- • 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.
- • 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.
Required
- • 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.
- • Strong communication, ownership and decision-making skills.
- • Common sense and flexibility
Preferred
- • Experience with regulatory authority interactions is preferred.
Benefits & Perks
- • 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
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.)
Responsibilities
Medical 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.
- 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.
- 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.
- 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
Working at Faeth
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
- Mission oriented, remote first culture
All offers of employment are contingent upon satisfactory completion of a background check and verification of eligibility to work in the United States.
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