Clinical Development Medical Director (CDMD)
Health Plaza East Hanover, NJ 07936 US
The Clinical Development Medical Director (CDMD) is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As CDMD, you will have oversight of the clinical development for the assigned programs and drive execution of the clinical development plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs. Your responsibilities will include, but are not limited to:
- Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
- Leading development of clinical sections of trial and program level regulatory documents
- Driving execution of the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable
- Supporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues
- Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas
- As a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
- May work with NIBR (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.
What you bring to the role:
- MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in oncology or hematology preferred
- Minimum of 7 years of experience in clinical research or drug development
- Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required. * 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 required.
- Working knowledge of disease area is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
- Demonstrated ability to establish effective scientific partnerships with key stakeholders
- Seeking candidates with Nephrology specialty experience
- Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
- Previous global people management experience is preferred, though this may include management in a matrix environment.
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