Executive Medical Director, Obesity

Role Summary

The Executive Medical Director, Obesity will oversee a team of physician-scientists responsible for evidence generation for obesity and obesity-related conditions and will report to the Vice President, Obesity. This role leads development of the global evidence generation plan, provides clinical input for safety and regulatory interactions, interprets trial data, and communicates medical findings to internal and external stakeholders. It requires strong leadership in clinical development, cross-functional collaboration, and strategic engagement with key opinion leaders and governance forums.

Responsibilities

• Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for multiple metabolic assets.
• Support (and lead when requested) cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program.
• Participate and provide clinical input into safety and regulatory interactions.
• Interpret and communicate clinical trial data.
• Oversee the authoring of clinical study reports, publications and regulatory submissions.
• Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated by the Vice President.
• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization.
• Contribute to TPP (target product profile) and Global Product Safety (GPS) development.
• Create development options and present to Global Dev Review Committee (GDRC), Therapeutic Area Governance (TAG), and Portfolio Governance.
• Interact with TA leadership and extended team to develop strategic options.
• Interact and collaborate with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative later development options.
• Provide clinical and scientific input to business development interactions including due diligence processes.

Qualifications

• Required: MD or DO degree from an accredited medical school; Five years of industry or academic research; Six years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
• Preferred: Five or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) in obesity or obesity-related conditions.
• Preferred: Eight or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities.
• Preferred: Previous experience in regulatory interactions.
• Preferred: Strong and versatile clinical development experience in endocrinology and accreditation in relevant sub-specialty.
• Preferred: Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes.
• Preferred: Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes.
• Preferred: Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements.
• Preferred: Leadership experience/potential as a medical expert in a complex matrix environment.
• Preferred: Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
• Preferred: Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path.