Medical Director, Clinical Development

Job Description

Job Description

Salary : $208,000 - $254,000

Job Summary

We are seeking a highly motivated Medical Director, Clinical Development to lead the execution of our early-stage clinical programs (Phase III) who will report directly to the VP, Clinical Development. This individual will serve as the primary sponsor representative overseeing outsourced clinical trials run by CRO partners, ensuring scientific integrity, patient safety, and operational excellence. In our entrepreneurial environment, the Medical Director will be both strategic and hands-on, playing a central role in shaping our clinical development path while collaborating closely with internal stakeholders and external experts. The ideal candidate will work in our hybrid office a minimum of 3 days per week.

Duties and Responsibilities

• Contribute to the design and implementation of clinical development plans, protocols, and study designs in alignment with corporate goals and regulatory expectations.
• Draft and review study-related documents including protocols, investigator brochures, IND amendments, and clinical sections of regulatory submissions.
• Support the VP, Clinical Development in preparing presentations for executive leadership, board meetings, and scientific / medical forums.
• Act as sponsor lead for Phase III trial(s), ensuring compliance with protocol, GCP, and regulatory standards.
• Provide day-to-day oversight of study conduct and collaborate with internal cross-functional teams, CROs and other external vendors (eg, clinical operations, regulatory, data management, biostatistics, pharmacovigilance, medical writing).
• Partner with pharmacovigilance providers to ensure accurate, timely safety reporting.
• Collaborate with Clinical Development Scientist team to ensure timely review of data listings, safety reports, and interim analyses to support timely, data-driven decisions.
• Monitor trial progress and timelines proactively to identify and mitigate risks.
• Participate in safety monitoring activities, including clinical review of adverse events, dose-escalation discussions, and safety data reconciliation.
• Provide medical / scientific guidance to investigators and clinical sites.
• Engage with key opinion leaders (KOLs)and investigators to inform study design and program advancement.
• Contribute medical and scientific expertise to publications, abstracts, and presentations.

What is Required