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

AstraZeneca; Boston (MA); Hybride; USD 250 000 - 350 000; Plein temps

Résumé du poste

A leading company in pharmaceuticals is seeking an Executive Medical Director for Gastroenterology and Early R&I Clinical Development. This pivotal role requires expertise in clinical development, particularly in immunology, to drive drug development initiatives and manage cross-functional teams. The candidate will have a strong background in clinical trial design and regulatory guidelines, with an emphasis on collaboration and strategic outcomes.

Qualifications

• 10+ years in clinical development within immunology.
• Proven leadership in cross-functional teams.
• Strong understanding of drug development and clinical trial design.

Responsabilités

• Lead design and delivery of clinical studies ensuring GCP compliance.
• Provide medical strategy and expertise across teams.
• Collaborate to ensure efficient clinical development plans.

Connaissances

Leadership

Communication

Analytical skills

Problem-solving

Collaboration

Formation

MD or MD/PhD

Description du poste

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

Join AstraZeneca as the Executive Medical Director, Gastroenterology, Early R&I Clinical Development.

Make a meaningful impact on patients’ lives worldwide. At AstraZeneca, science drives us to transform lab breakthroughs into medicines for complex diseases, addressing unmet medical needs through innovative science and patient-centered outcomes.

The Role

This position offers an excellent opportunity for a motivated drug developer to shape the gastroenterology and immunology pipeline and lead innovative clinical programs. You will provide medical leadership for preclinical and clinical assets, including indications such as UC and Crohn’s disease, across modalities like small molecules, monoclonal antibodies, bispecifics, and oligonucleotides. Your responsibilities include developing clinical plans, designing studies, writing protocols, medical monitoring, and collaborating with internal and external partners to ensure timely and high-quality execution. You will also engage in external innovation and business development activities.

The ideal candidate will excel in a fast-paced, proactive culture, demonstrate excellent communication and collaboration skills, and be a strong team player.

Key Responsibilities

• Lead the design, delivery, and interpretation of clinical studies, ensuring ethical and scientific integrity in compliance with GCP.
• Provide medical strategy and expertise to research, translational medicine, clinical development, and commercial teams, shaping therapeutic area strategies.
• Stay abreast of medical developments in assigned areas and translate emerging data into adaptable clinical plans.
• Collaborate across functions to ensure high-quality, efficient clinical development plans.
• Represent early R&I clinical development to external stakeholders, including investigators and patient advocacy groups.
• Lead regulatory communication and prepare high-level documents.
• Ensure peer review of study and program designs.
• Support qualification of pharmacodynamic and disease markers for early efficacy assessment.
• Contribute clinical insights to in-licensing opportunities.

Qualifications

• MD or MD/PhD with expertise in gastroenterology.
• 10+ years in clinical development within immunology, with experience from first-in-human to Phase 2b trials.
• Proven leadership in cross-functional teams and results delivery.
• Excellent communication, organizational, and strategic skills.
• Deep understanding of drug development, clinical trial design, and biostatistics.
• Knowledge of FDA, MHRA, and ICH GCP guidelines for global study conduct.
• Attention to detail, passion, and urgency to meet goals.
• Experience managing complex projects and stakeholder collaboration.
• Strong analytical and problem-solving skills.
• Ability to thrive in a dynamic environment.

Location: Boston, MA

We promote a flexible, inclusive work environment with a minimum of three days in the office per week, fostering innovation and collaboration.

At AstraZeneca, we are committed to diversity, equity, and lifelong learning. We welcome applications from all qualified candidates and provide accommodations as needed.

Important Dates

Posted: 27-May-2025

Closes: 26-May-2025