Summary
The Medical Director, Clinical Sciences, Endocrinology, will play a key role in clinical development programs within the General Medicine portfolio focused on obesity and related comorbidities.
This role serves as Scientific and Medical Lead for Clinical team(s) working closely with Operational Leads to guide and execute clinical development strategies and subsequent regulatory submissions.
This role requires a high-performing and highly passionate individual who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research.
The Medical Director General Medicine reports to an Executive Director, General Medicine.
A Typical day may include the following :
- Acts as medical expert and leader in interactions with external stakeholders.
- Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
Designs and develops more efficient and innovative, yet robust Phase 2 / 3 programs.
- Works closely with discovery teams to provide input on the next generation of targets in the field and leads the development of plans for Phase 1 clinical testing for initial characterization of the molecules PK / PD and safety.
- Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety.
- Plans and executes publication and clinical communication strategy in coordination with Publications team. Provides input to key external presentations.
- Ensures quality of all clinical documents (e.g., Investigators’ Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents).
Develops written responses to regulatory agency questions and regulatory submission documents.
This may be the role for you if :
- A minimum of an advanced degree in medicine (i.e., M.D. or D.O. or equivalent).
- Clinical training in Endocrinology / Metabolism Practitioner (board certified or eligible or equivalent) is preferred.
- A 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.
- 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.
- Experience with regulatory filings and interactions with health authorities
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