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Senior Clinical Development Medical Director
2 months ago
Key Responsibilities:
- Provide strategic medical input and leadership for clinical deliverables in assigned projects or sections of clinical programs.
- Develop and lead the clinical sections of trial and program-level regulatory documents.
- Drive the execution of assigned clinical programs and/or clinical trials in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates.
- Support the overall safety of the molecule for assigned sections and act as a core member of the Safety Management Team, collaborating with Patient Safety colleagues.
- Contribute to the development of Clinical Development Plans, Integrated Development Plans, and Clinical Trial Protocols, and drive the development of disease clinical standards for new disease areas.
- Support interactions with external and internal stakeholders and decision boards as a medical expert.
- Collaborate with Business Development & Licensing to drive the transition of pre-PoC projects to DDP and with BR to drive the transition of pre-PoC projects to DDP.
- MD or equivalent medical degree with advanced knowledge and clinical training in medical/scientific area; Clinical practice experience of 4 years (including residency) and board certification or eligibility in disease area 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 the 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.
- 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.