Role Description
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
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Medical Monitoring
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Serve as the primary Medical Monitor for assigned clinical trials.
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Provide ongoing medical oversight to ensure patient safety and protocol compliance.
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Review eligibility queries, protocol deviations, and safety data in real time.
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Collaborate with Safety/Pharmacovigilance on SAE review, signal detection, and benefit-risk assessments.
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Support investigator communications and training related to medical and safety matters.
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Data Review & Quality Oversight
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Lead ongoing clinical data review to ensure integrity, completeness, and scientific validity.
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Partner with Clinical Operations and Data Management to ensure high data quality standards.
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Identify data trends, inconsistencies, and potential safety or efficacy signals.
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Contribute to statistical analysis planning and interpretation of study results.
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Ensure readiness for database lock and regulatory submissions.
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Cross-Functional Clinical Development Leadership
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Provide strategic guidance across functions to optimize trial design, recruitment, and execution.
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Contribute to translational and biomarker strategies.
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Collaborate cross-functionally on briefing documents, INDs, NDAs/BLAs, and agency interactions.
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Lead medical communications including abstracts, manuscripts, and congress presentations.
Qualifications
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M.D. degree or PA/NP/PhD
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2+ years as a clinical scientist or medical director in the biotech or pharmaceutical industry.
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Prior experience serving as a Medical Monitor for interventional clinical trials.
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Experience in clinical data review and ensuring data quality.
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Experience leading cross-functional clinical development teams.
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Experience with regulatory authority interactions is preferred.
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Strong communication, ownership and decision-making skills.
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Common sense and flexibility.
Requirements
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Compensation Range: $325,000 - $400,000 (actual compensation may vary based on experience, qualifications and location)
Benefits
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Competitive salary and equity in a well-funded, clinical-stage biotech
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100% remote work and flexible schedule
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Health, dental, and vision for you and your dependents
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Flexible time off
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Generous parental leave
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Traditional and Roth 401k
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Mission oriented, remote first culture