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

Make a more meaningful impact to patients’ lives around the globe

Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

The Role:

This is an excellent opportunity for a motivated drug developer to shape the gastroenterology and immunology pipeline and lead innovative clinical stage programs. 

In this position, you will provide medicalleadership opportunities for preclinical and clinical stage assets, across key indications such as UC and Crohn’s disease and spanning multiple modalities (small molecules, monoclonal antibodies, bi-specific and tri-specific antibodies, oligonucleotides). You will provide clinical development leadership for cross-functional teams to support early phase clinical development activities. Theseincludethe creation ofoverall clinical development plans and clinical study design, as well writing protocols, medical monitoring and ensuring timely execution of studies, all in close collaboration with relevant internal and external partners and clinical research organizations, and involvement in in-scope external innovation / business development activities.

The successful candidate will thrive in a fast-paced, proactive can-do culture, be a highly-effective internal and external team player as well as terrific communicator and collaborator.

What you will do:

• 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 areasand disseminatenew 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

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

Location: Boston, MA

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.