Clinical Development Medical Director
About this role
Job Description Summary
The Senior Clinical Development Medical Director (Sr CDMD) will lead the end-to-end strategy and execution of assigned renal clinical development program(s) across the full Research, Development and Commercial (RDC) continuum; from early development through pivotal/registrational phases. This is a key leadership role requiring hands-on experience in both early and late phase renal drug development. With the ability to translate emerging data into a clear clinical and regulatory path, drive delivery in a global matrix, and ensure rigorous benefit–risk decision making throughout the program lifecycle.
Job Description
Major accountabilities:
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 BR (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.
Requirements
- 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 disease area preferred
- Minimum of 10 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 is required.
- Working knowledge of renal 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
- 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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