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Senior Medical Director, Clinical Development, Obesity
2 months ago
We are seeking a highly skilled and experienced Senior Medical Director to lead our clinical development programs in obesity and related comorbidities within our General Medicine portfolio. As a key member of our team, you will play a critical role in guiding and executing clinical development strategies and subsequent regulatory submissions.
Key Responsibilities- Scientific and Medical Leadership: Serve as a medical expert and leader in interactions with external stakeholders, including regulatory agencies and industry partners.
- Clinical Strategy Development: Develop innovative and efficient clinical strategies to shorten the development cycle in the face of an evolving regulatory landscape.
- Program Management: Lead the development of Phase 2/3 programs, working closely with discovery teams to provide input on next-generation targets and lead the development of plans for Phase 1 clinical testing.
- Safety and Quality Assurance: Ensure the safety of our drugs, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance.
- Publication and Communication Strategy: Plan and execute publication and clinical communication strategies in coordination with our Publications team.
- Regulatory Submissions: Ensure the quality of all clinical documents and develop written responses to regulatory agency questions and regulatory submission documents.
- Advanced Degree: Minimum of an advanced degree in medicine (M.D. or D.O. or equivalent).
- Clinical Training: Clinical training in Endocrinology / Metabolism Practitioner (board certified or eligible or equivalent) is preferred.
- Industry Experience: Minimum of 6 years of industry experience (majority in late clinical development); however, a candidate with a strong academic background and less experience may be considered.
- Leadership Experience: Past experience in leading registrational clinical trials, including protocol design, managing study start-up, directing and guiding study team execution, data cleaning, medical monitoring/review, database locks.
- Regulatory Experience: Experience with regulatory filings and interactions with health authorities.
