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Clinical Development Medical Director
3 weeks ago
Clinical Development Medical Director - Cardiovascular
Summary
The Clinical Development Medical Director (CDMD) is the clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), or a large, complex trial, under the leadership of the (Sr.) GPCH.
About The Role
Your responsibilities include, but are not limited to:
Provide clinical leadership and medical strategic input for deliverables in the assigned project/program.
Deliverables may include sections of individual protocols consistent with the IDP, data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications (e.g., IBs, Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
Drive execution of the section of the program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates
Oversee/conduct medical and scientific review of trial data with Clinical Scientific Expert(s).
May be the Program Manager of other associates (e.g.., CSE).
May function as study medical monitor
Support SR/GPCH in ensuring overall safety of the molecule.
May be a core member of the Safety Management Team (SMT), and supports program safety reporting (e.g., PSURs, DSURs, and safety related documents) in collaboration with Patient Safety
Support the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for disease areas.
Provide support to the (Sr.) GPCH or TAH in interactions with external partners (e.g., regulatory authorities, KOLs, data monitoring boards, AD Boards, patient advocacy groups), internal partners (e.g., CTT, Research, Translational Medicine, GMA, Marketing, HE&OR), and decision boards)
Work with BR (Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences together with additional matters
Ensure career development of Program reports and clinical colleagues through active participation in performance management and talent planning processes.
Provide on-boarding, training, & mentoring support
Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule.
May serve as speaker for franchise.
May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
Minimal Requirements
MD (or equivalent medical degree) is required.
Medical Board certification preferred.
4+ years Clinical practice experience (including residency) is preferred
Possess advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) is required.
5+ years' experience in clinical research or drug development from the pharma/biotech industry spanning clinical activities in Phases I through IV.
3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global/matrix environment
Showcase advanced knowledge of assigned therapeutic area
Demonstrate ability to establish strong scientific partnership with key partners
Need thorough knowledge of GCP, trial design, statistical analysis methodology, and regulatory/ clinical development process
Have people management experience preferred, this may include management in a matrix environment.
Global people management is preferred.
Exhibit excellent business communication and presentation skills
Possess strong interpersonal skills
Adept with excellent negotiation and conflict resolution skills
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