Medical Director Clinical Development Lead
Vor 4 Tagen
About the Role
As a key member of our team at the Healthcare Businesswomen's Association, we are seeking an experienced Clinical Development Medical Director to lead the strategic and operational planning and management of assigned clinical programs from an end-to-end clinical operations perspective.
The successful candidate will provide clinical leadership and strategic medical input for all clinical deliverables in assigned projects or sections of clinical programs, leading the development of clinical sections of trial and program level regulatory documents.
Responsibilities
- Provide clinical leadership and strategic medical input for all clinical deliverables in assigned projects or sections of clinical programs.
- Lead the development of clinical sections of trial and program level regulatory documents.
- Drive execution of assigned clinical programs and/or clinical trials in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable.
- Support (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.
- Support 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, support the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards.
- May work with 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 diligence together with other medical matters, as needed.
What We Are Looking For
- 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 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.
- 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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