Senior Director, Medical Monitor & Safety Physician

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Medical Monitor & Safety Physician based in United States.

This senior clinical safety leadership role plays a critical part in ensuring patient safety and robust benefit–risk evaluation across global clinical programs in nephrology and metabolic diseases. The position combines hands-on medical monitoring with strategic pharmacovigilance leadership, ensuring the highest standards of safety oversight from early development through post-marketing stages. Operating within a fast-paced, matrixed environment, the role partners closely with clinical development, regulatory, biostatistics, pharmacovigilance, and clinical operations teams. The Senior Director is responsible for guiding safety decision-making, supporting regulatory interactions, and ensuring consistency in global safety processes. This is a highly influential role where medical judgment directly shapes clinical trial conduct, risk mitigation strategies, and regulatory outcomes. It offers the opportunity to contribute meaningfully to the development of therapies for patients with serious and rare diseases.

• Serve as Medical Monitor for assigned clinical trials (Phase 1–3 and post-marketing), providing real-time medical oversight, ensuring patient safety, and supporting protocol compliance across studies.
• Conduct detailed medical review of adverse events, serious adverse events, dosing decisions, eligibility questions, and safety signals, including determination of relatedness, expectedness, and seriousness.
• Contribute to safety strategy development, including Risk Management Plans, safety surveillance frameworks, AESI definitions, and escalation pathways.
• Provide clinical input into study protocols, informed consent documents, investigator brochures, and safety management plans to ensure accurate risk communication and mitigation strategies.
• Lead or support aggregate safety analyses and reporting activities, including DSURs, PSUR/PBRERs, case series reviews, and targeted safety assessments.
• Support regulatory interactions, inspection readiness activities, and safety-related submissions, ensuring alignment with global pharmacovigilance requirements.
• Participate in DSMB/DMC processes, adjudication committees, investigator meetings, and cross-functional governance forums to support data interpretation and decision-making.
• Provide medical leadership within cross-functional and external partner teams, ensuring alignment on safety strategy, operational execution, and compliance standards.
• Support continuous improvement of safety systems, SOPs, CAPAs, and quality processes in accordance with GxP and ICH guidelines.

Requirements:

• MD or DO (or equivalent international medical qualification) required.
• 8+ years of experience in clinical development and/or pharmacovigilance, including substantial medical monitoring experience in interventional clinical trials.
• Strong expertise in global drug safety regulations, ICH guidelines, and pharmacovigilance systems across development and post-marketing settings.
• Experience with Phase 1–3 clinical trials, including early development and dose-escalation studies preferred.
• Demonstrated experience in aggregate safety reporting (DSUR, PSUR/PBRER) and risk management planning (RMP).
• Strong clinical judgment with the ability to evaluate complex safety data and translate findings into clear, actionable recommendations.
• Experience engaging with regulatory authorities (FDA, EMA, and others) and contributing to submissions, briefing packages, and safety communications.
• Excellent communication skills, including the ability to clearly present medical and safety insights to diverse stakeholders.
• Strong collaboration and influencing skills within matrixed, cross-functional, and vendor-based environments.
• High attention to detail, strong organizational skills, and ability to manage multiple priorities in a fast-evolving environment.
• Willingness to travel domestically and internationally (up to 20–25%).

Benefits:

• Competitive base salary range of $233,000 – $315,000, plus short-term incentive and long-term equity compensation opportunities.
• Comprehensive medical, dental, vision, life, and disability insurance coverage for employees and eligible dependents.
• Retirement savings plan with employer matching contributions.
• Generous paid time off, holidays, and flexible work-life balance support programs.
• Access to wellness initiatives and employee assistance resources.
• Opportunity to work on high-impact rare disease programs with global clinical and regulatory exposure.
• Strong cross-functional leadership role with visibility across development, safety, and regulatory functions.
• Robust professional development in global pharmacovigilance and clinical safety leadership.