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Role Summary
Executive Medical Director, Obesity. Oversees a team of physician-scientists that support evidence generation for obesity and obesity-related conditions, and reports to the Vice President, Obesity.
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 CfDA, CfOR, CPMS, etc., to bring innovative later development options
- Provide clinical and scientific input to business development interactions including due diligence processes
Qualifications
- 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 Qualifications
- Five or more years of clinical research experience in the biopharmaceutical industry in obesity or obesity-related conditions
- Eight or more years of clinical research and/or basic science research with clinical teaching and patient care activities
- Previous experience in regulatory interactions
- Strong clinical development experience in endocrinology and relevant sub-specialty
- Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes
- Experience developing study concepts for clinical development and trial designs with cross-functional input
- Knowledge of GCP, FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
- Leadership experience in a complex matrix environment
- Ability to present and document complex medical concepts in written and oral form
- Strong interpersonal and problem-solving skills with sound judgment
Skills
- Clinical and scientific communication
- Cross-functional collaboration
- Regulatory and safety liaison
- Strategic development planning
- Medical leadership and mentorship
Education
- MD or DO degree from an accredited medical school