(Senior) Clinical Development Director - CV
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About The Role
The Senior Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit leads the strategic planning and management of the assigned clinical program(s) from an end‑to‑end clinical development perspective.
As a Senior CDD in the Cardiovascular/Metabolic TA, you oversee the clinical development for the assigned programs and drive the execution of the clinical development plan. In addition, you enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.
Main Responsibilities
* Provide clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program. Deliverables include clinical sections of individual protocols or sub studies, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications.
* Lead development of clinical sections of trial and program level regulatory documents.
* Drive execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates.
* Oversee/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead.
* Support (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section and may be a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety.
* Act as a clinical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards.
* Contribute to scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training and may be the Program Manager of other associates.
Minimum Requirements
* Advanced degree in life sciences / healthcare (or clinically relevant degree) is required. PharmD or PhD is strongly preferred.
* Fluent oral and written English.
* Minimum 5 years for CDD and 7 years experience for Snr CDD experience in clinical research or drug development.
* Working knowledge of the assigned disease area (Cardiovascular) is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level.
* Demonstrated ability to establish effective working relationship with key investigators.
* Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
* Strong communication skills with the ability to work in a cross‑functional and global organization.
Benefits and Rewards
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Why Novartis
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. With our people, we achieve breakthroughs that change patients’ lives.
Equal Employment Opportunity
Novartis is an equal opportunity employer and encourages applications from all qualified candidates, including women, minorities, veterans, and people with disabilities. If you require assistance or accommodations during the application process, please contact the Novartis Disability Access Hotline.
Join Our Novartis Network
If this role is not suitable to your experience or career goals but you wish to stay connected, join the Novartis Network here: https://talentnetwork.novartis.com/network
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