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

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.

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 medical leadership 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. These include the creation of overall 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.

• 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

• 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…