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

AstraZeneca

Executive Medical Director role leading gastroenterology and immunology clinical development programs at AstraZeneca's Boston site. Provides medical strategy and clinical expertise for early-stage assets across multiple therapeutic modalities, managing cross-functional teams and regulatory communications.

Responsibilities

Lead clinical study design, execution, and interpretation ensuring ethical and scientific integrity
Develop clinical development plans and therapeutic area strategy across gastroenterology and immunology programs
Represent early R&I clinical development to external stakeholders including investigators and regulatory bodies
Collaborate with cross-functional teams to ensure timely delivery of high-quality clinical development plans
Serve as medical lead for regulatory communications and preparation of regulatory documents

Requirements

MD or MD/PhD in relevant scientific discipline with gastroenterology expertise
10+ years clinical development experience in immunology indications
Early-stage clinical development background from first-in-human through Phase 2b
Demonstrated leadership of cross-functional teams delivering measurable results
Strong command of FDA, MHRA, ICH GCP guidelines and clinical trial design principles
Excellent verbal, written communication and organizational skills
Experience managing complex projects across multiple internal and external stakeholders

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Vacancy posted 20 days ago

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