US-NJ, Associate Clinical Development Medical Director 213699BR-MZ
Associate Clinical Development Medical Director
Global Drug Development
East Hanover, NJ
Research & Development
The Associate Clinical Development Medical Director (Assoc. CDMD) is responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring, and reporting of quality data. May be responsible for the scientific and medical strategy of assigned sections of a clinical development program, depending on the size and complexity.
Provides clinical leadership, medical and scientific strategic input, and contributes to development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP); develops materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations
2) Provides medical and scientific input and contributes to clinical sections of trial and program level regulatory documents (e.g., Investigator s Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities)
3) In collaboration with appropropriate Clinical Trial Team (CTT) members:
a) Ensures direct medical support of trials as needed and may act as medical monitor
b) Conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)
c) Manages patient safety and reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT)
d) Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations
4) Under the direction of the (Sr.) GPCH or (Sr.) CDMD, contributes to ensuring overall safety of the compound for assigned trial(s) in collaboration with Patient Safety
5) Supports Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs
6) Supports development of TA strategies, as needed
7) May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities
8) Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; develops and fosters CD culture; and may contribute to the performance evaluation of CTT members
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9) 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
10) Contributes to 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 certification preferred; Clinical practice experience 4 years (including residency) preferred.
Fluent oral and written English
3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 2 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
Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
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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, written and oral
Strong interpersonal skills
Strong negotiation and conflict resolution skills
Proven ability to work independently or in a cross-functional team setting.
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