US-NJ, Clinical Development Medical Director 213300BR-MZ
Clinical Development Medical Director
Global Drug Development
East Hanover, NJ
Research & Development
The Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), or a large, complex trial, under the leadership of the (Sr.) GPCH. May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase). Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
2) Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
3) Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable
4) Oversees/conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)
5) May be the Program Manager of other associates (e.g.., CSE).
6) May act as study medical monitor
7) Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
8) Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
9) As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
10) May work with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed
11) Ensures career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support
12) Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
13) May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board CDMD certification preferred; Clinical practice experience 4 years (including residency) preferred.
Fluent oral and written English
5 years of involvement in clinical research or drug development in an academic or industry environment 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 in pharmaceutical industry
Advanced knowledge of assigned therapeutic area
Demonstrated ability to establish strong scientific partnership with key stakeholders
Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
People management experience preferred, this may include management in a matrix environment. Global people management experience desirable
Excellent communication skills, written and oral
Strong interpersonal skills
Excellent negotiation and conflict resolution skills
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