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

Role Summary

Executive Medical Director, Gastroenterology, Early R&I Clinical Development. Lead medical strategy and development for gastroenterology and immunology programs, shaping early stage clinical development and cross-functional collaboration to deliver high-quality, rapid progress in UC and Crohn’s disease across multiple modalities.

Responsibilities

• Single point accountable leader for design, delivery and interpretation of clinical studies ensuring ethical and scientific integrity in line 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
• Monitor medical developments within assigned areas and translate emerging data into agile clinical plans
• Collaborate across early and late R&I clinical development, partner functions and wider organization to ensure high-quality, timely clinical development plans
• Represent early R&I clinical development to external stakeholders, investigators, experts, governmental/policy groups and patient advocacy groups
• Medical Lead for regulatory communication and preparation of higher-level documents
• Ensure internal and external peer review of potential study/program design
• 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, with background in early clinical development (First-in-Human through Phase 2b)
• Demonstrated track record in leading cross-functional teams and delivering results
• Outstanding verbal and written communication skills, with 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 to enable innovative and efficient trial design
• Thorough command of FDA, MHRA and ICH GCP guidelines for conduct of clinical studies in US, Europe and elsewhere
• Attention to detail and drive to produce high-quality work with 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

Location

Boston, MA