Medical Director

Position Summary

The Medical Director, Gastro/ Hep will play a pivotal role in overseeing the clinical development programs and driving medical affairs for PBC and eventually, other autoimmune pipeline assets. This position requires a strategic and hands-on leader with extensive experience in clinical trials, regulatory strategy, and medical communications. The ideal candidate will work closely with cross-functional teams, including research, regulatory, and clinical operations, to ensure that our client's clinical programs meet scientific, regulatory, and patient needs.

Key Responsibilities

Clinical Development

• Lead the design, implementation, and execution of clinical development strategies for PBC and other pipeline assets.
• Provide medical oversight for clinical trials, ensuring that studies are scientifically sound, ethically conducted, and compliant with regulatory requirements.
• Collaborate with the Clinical Operations team to develop study protocols, ensure effective trial management, and monitor safety and efficacy data.
• Drive the interpretation of clinical data and ensure robust communication of trial results.
• Support regulatory filings (IND, NDA, BLA, etc.), including the preparation of clinical documents (e.g., clinical study reports, regulatory submissions) and responses to regulatory agency queries.
• Partner with clinical teams to identify and address potential challenges in clinical development and implement appropriate solutions.

Medical Affairs

• Serve as a medical expert to internal and external stakeholders, including investigators, clinical sites, regulatory bodies, and key opinion leaders (KOLs).
• Develop and implement strategies for post-marketing surveillance, including safety monitoring and risk management.
• Provide scientific and clinical input to commercialization strategies, including label claims and market access.
• Support the development of medical education materials, scientific publications, and presentations for medical and commercial stakeholders.
• Lead the preparation and delivery of scientific presentations to internal and external audiences, including medical and clinical advisory boards, congresses, and regulatory bodies.
• Contribute to the development of medical strategies for the launch and lifecycle management of therapeutic products.

Cross-Functional Leadership

• Collaborate with the R&D, regulatory, clinical operations and client's executives to develop & implement clinical development and medical affairs strategies that align with company & program objectives.
• Advise senior leadership on clinical development strategy, therapeutic area trends, and emerging regulatory and scientific developments.
• Provide mentorship and leadership to clinical program teams, ensuring high standards of scientific rigor and operational excellence.
• Contribute to the establishment and refinement of clinical development processes, best practices, and departmental objectives.

Qualifications

Education & Experience

• MD degree; board certification in gastroenterology and/or hepatology is a plus.
• Minimum of 8-10 years of experience in clinical development and/or medical affairs in the biotechnology or pharmaceutical industry, with a strong track record in drug development, clinical trial design, and regulatory submission.
• Experience in Phase II - Phase III clinical trials; drug approval/ launch is strongly preferred.
• Clinical development leadership experience, specifically in autoimmune and/or diabetes, is strongly preferred.
• Knowledge of regulatory requirements and agency interactions, including IND submissions, clinical trial applications, and meetings with the FDA/EMA.
• Experience in managing relationships with key opinion leaders, clinical investigators, and medical advisory boards.
• Leadership skills & competencies:
• Strong leadership and project management skills, with the ability to drive initiatives and collaborate effectively across departments.
• Excellent communication skills, with the ability to present complex scientific data to diverse audiences, including non-medical stakeholders.
• Ability to think strategically while being hands-on with operational aspects of clinical development and medical affairs.
• Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities.