GI Medical Director - Early Clinical Development

Regulatory Toolkit; Boston (MA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

AstraZeneca in Boston, MA seeks a motivated drug developer to shape the gastroenterology and immunology pipeline and lead innovative clinical stage programs. You will provide medical leadership for preclinical and clinical assets across UC and Crohn's disease, spanning modalities, and lead cross-functional teams in study design, monitoring, and execution.

The role requires an advanced clinical degree and a track record in immunology development, with strong communication and collaboration skills

Qualifications

• Advanced degree in a relevant scientific discipline (MD or MD/PhD) with specific experience in gasteroenterology.
• 10+ years of experience in clinical development in relevant immunology indications, with background working in 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, in addition to excellent organizational skills.
• 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 facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules.
• Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world.
• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
• Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication.
• Excellent analytical, problem-solving and strategic planning skills.
• Ability to thrive in a fast-paced environment.

Responsibilities

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

Education

MD or MD/PhD in relevant field

Job description

AstraZeneca in Boston, MA seeks a motivated drug developer to shape the gastroenterology and immunology pipeline and lead innovative clinical stage programs. You will provide medical leadership for preclinical and clinical assets across UC and Crohn's disease, spanning modalities, and lead cross-functional teams in study design, monitoring, and execution.

The role requires an advanced clinical degree and a track record in immunology development, with strong communication and collaboration skills