The Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As a CDD in the CV TA, you will oversee clinical development for the assigned programs and drive the execution of the clinical development plan. You will enable an empowered organization capable of navigating a matrix environment and adapting quickly to business needs.
About the Role
Major accountabilities:
1. Providing clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program, including clinical sections of protocols, clinical data review, standards, regulatory documents, and publications.
2. Leading development of clinical sections of trial and program-level regulatory documents.
3. Driving execution of the clinical program section in partnership with global line functions, Global Trial Directors (GTDs), and regional/country medical associates.
4. Overseeing ongoing medical and scientific review of clinical trial data with Clinical Scientific Experts, under Medical Lead oversight.
5. Supporting (Senior) GPCH in ensuring overall safety of the molecule; may be a core member of the Safety Management Team.
6. Supporting interactions with external and internal stakeholders and decision boards as a clinical expert.
7. Contributing to scientific training on the disease area and compound; may serve as speaker or Program Manager for other associates.
Qualifications:
* Advanced degree in life sciences/healthcare (PharmD or PhD preferred).
* Minimum of 7 years experience in clinical research or drug development.
* Knowledge of the disease area, clinical trial design, GCP, statistics, and regulatory processes.
* Strong communication skills and ability to work in a cross-functional, global organization.
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