Executive Medical Director, Gastroenterology, Early R&I Clinical Development

Role Summary

Executive Medical Director, Gastroenterology, Early R&I Clinical Development. Lead medical strategy and clinical development for preclinical and early-phase assets in gastroenterology and immunology, focusing on indications such as UC and Crohn’s disease across multiple modalities. Provide medical leadership for cross-functional teams, develop development plans and study designs, and collaborate with internal and external partners to advance early clinical programs.

Responsibilities

• Single point accountable leader for design, delivery and interpretation of clinical studies ensuring ethical and scientific integrity in compliance with GCP
• Provide medical strategy and clinical expertise to Research, Translational Medicine, Early and Late stage Clinical Development and Commercial Partners, including therapeutic area strategy development
• Monitor medical developments within assigned areas and disseminate information to transform trends into agile clinical plans
• Collaborate across early and late R&I development, partner functions and wider organization to ensure high-quality, timely clinical development plans
• Represent early R&I clinical development to external stakeholders including investigators, external experts, governmental/policy groups and patient advocacy groups
• Medical Lead for regulatory communication and preparation of higher-level documents
• Oversee internal and external peer review of potential study/program designs
• Support qualification of pharmacodynamic/disease markers for early efficacy assessment
• Provide clinical strategic input to in-licensing opportunities

Qualifications

• Advanced degree in a relevant scientific discipline (MD or MD/PhD) with specific experience in gastroenterology
• 10+ years of experience in clinical development in relevant immunology indications, including early clinical development (first-in-human through Ph2b)
• Demonstrated track record in leading cross-functional teams and delivering results
• Outstanding verbal and written communication skills and excellent organizational abilities
• Understanding of the entire drug development process, including clinical and non-clinical study design and execution
• Thorough understanding of clinical research methodology and biostatistics principles for innovative and efficient trial design with data-driven decision rules
• Strong knowledge of FDA, MHRA and ICH GCP guidelines for conducting studies in the US, Europe and elsewhere
• Attention to detail, initiative and urgency to achieve goals
• Experience managing complex projects and collaborating with multiple stakeholders to ensure consistent communication
• Excellent analytical, problem-solving and strategic planning skills
• Ability to thrive in a fast-paced environment

Education

• Advanced degree (MD or MD/PhD) in a relevant scientific field

Location

Boston, MA