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

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 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.

Qualifications

• Advanced degree in a relevant scientific discipline (MD or MD/PhD) with specific experience in gastroenterology.
• 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.