Senior Director, Medical Monitor & Safety Physician (Medical)

TL;DR

Senior Director, Medical Monitor & Safety Physician (Medical): Ensuring patient safety and robust benefit–risk evaluation across global clinical programs in nephrology and metabolic diseases with an accent on medical monitoring and strategic pharmacovigilance leadership. Focus on guiding safety decision-making, supporting regulatory interactions, and designing risk mitigation strategies for rare diseases.

Location: Must be based in the United States

Salary: $233,000 – $315,000

What you will do

• Serve as Medical Monitor for Phase 1–3 and post-marketing trials, providing real-time medical oversight and ensuring patient safety.
• Conduct detailed medical reviews of adverse events, dosing decisions, and safety signals.
• Develop safety strategies, including Risk Management Plans (RMP) and safety surveillance frameworks.
• Provide clinical input for study protocols, informed consent documents, and investigator brochures.
• Lead aggregate safety reporting activities, including DSURs, PSUR/PBRERs, and targeted safety assessments.
• Support regulatory interactions with the FDA, EMA, and other authorities, ensuring alignment with global pharmacovigilance requirements.

Requirements

• MD or DO (or equivalent international medical qualification) is required.
• 8+ years of experience in clinical development and/or pharmacovigilance, including substantial medical monitoring.
• Strong expertise in global drug safety regulations, ICH guidelines, and pharmacovigilance systems.
• Experience with Phase 1–3 clinical trials, particularly early development and dose-escalation studies.
• Proven experience in aggregate safety reporting (DSUR, PSUR/PBRER) and risk management planning.
• Willingness to travel domestically and internationally (up to 20–25%).

Culture & Benefits

• Competitive base salary with short-term incentive and long-term equity opportunities.
• Comprehensive medical, dental, vision, life, and disability insurance for employees and dependents.
• Retirement savings plan with employer matching contributions.
• Generous paid time off, holidays, and flexible work-life balance support programs.
• Opportunity to lead high-impact rare disease programs with global regulatory exposure.