Executive Medical Director/SERM Head driving clinical safety and pharmacovigilance strategy for Oncology. Leading global teams to ensure highest standards of patient safety with focus on regulatory compliance.
About the role
- Providing or supporting 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, 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.
- Clinical practice experience (including residency/fellowship) and board certification or eligibility in Nephrology
- Experience in clinical research or drug development preferred
- Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.
- Experience in contributing to and accomplishing 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
Benefits
- Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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