Medical Director (Medical Monitoring)

Role Summary

Medical Director to lead medical monitoring activities across clinical development programs, serving as the primary medical contact for ongoing trials, ensuring patient safety, data integrity, and protocol compliance. Provides medical oversight for study conduct, including real-time safety data review, adverse event assessments, and clinical endpoint evaluations. Collaborates with cross-functional teams to support trial execution, contribute to protocol development, medical review of data, and regulatory submissions.

Responsibilities

• Drive development programs, collaborating with Program Management, Clinical Operations, Regulatory Affairs, and cross-functional teams to design the phase III pivotal study supporting regulatory submissions.
• Serve as a medical monitor for clinical trials, ensuring high-quality evaluation of clinical and laboratory data, guiding decisions on recruitment, study conduct, and dose escalation or early signals as appropriate.
• Build and advance priority external relationships with KOLs and physicians to form a strategy aligned with patient, payor, and US customer needs.
• Provide input and leadership in preparing global regulatory filings, including IBs, INDs, CTAs, and NDAs.
• Facilitate engagement with academic investigators, support site initiation visits, and lead investigator meetings to foster collaboration and learning.
• Represent the company at scientific meetings and engage with key opinion leaders.
• Contribute to publications and presentations of clinical research findings.
• Partner with Pharmacovigilance to review and interpret clinical data, ensuring accuracy, context, and patient safety.
• Other responsibilities as assigned.

Qualifications

• Advanced scientific degree (M.D., Ph.D., Pharm.D., or M.S.) with progressive experience in medical or scientific affairs in pharma/biotech, or equivalent.
• Clinical development experience, preferably in metabolic, endocrine, or related therapeutic areas.
• Demonstrated expertise in late-stage clinical trials with understanding of regulatory requirements, data interpretation, and cross-functional collaboration.
• Hands-on experience in medical monitoring, including oversight of trial safety and data integrity.
• Proven track record contributing to regulatory submissions and engaging with global health authorities.
• Experience as a medical monitor with knowledge of GxP guidelines and trial conduct.
• Robust scientific publication history and effective presentation skills.
• Exceptional communication abilities, translating complex concepts into clear, actionable insights.
• Strong collaboration history in cross-functional teams.

Skills

• Medical monitoring
• Clinical data review and safety signal assessment
• Regulatory submissions and interactions with health authorities
• KOL and investigator relationship management
• Scientific writing and presentation
• Cross-functional collaboration

Education

• Advanced scientific degree (M.D., Ph.D., Pharm.D., or M.S.)

Additional Requirements

• Travel periodically as needed for business requirements and meetings.