Medical Director leading early clinical development in Immunology at Lilly, bridging discovery science and clinical application to drive transformational medicines.
About the role
- Lead clinical development for cancer treatment programs at Novartis, overseeing execution and strategic planning. Collaborate with global teams to ensure project success with a focus on safety and efficiency.
Responsibilities
- Lead the strategic planning and management of the assigned clinical program from an end-to-end clinical development perspective
- Oversight of the clinical development for the assigned programs and drive execution of the clinical development plan
- Provide 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
- Support the Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section
- 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
Requirements
- MD or equivalent medical degree required
- Advanced knowledge and clinical training in medical/scientific area
- Clinical practice experience: 4 years (including residency) preferred
- Minimum of 7 years of experience in clinical research or drug development with expertise in nuclear medicine
- Experience in an academic or industry environment spanning clinical activities in Phases I-4 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 Oncology
- Proven ability to interpret, discuss and present efficacy and safety data relating to clinical trials
- 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 preferred, though this may include management in a matrix environment
Benefits
- health, life and disability benefits
- 401(k) with company contribution and match
- vacation, personal days, holidays and other leaves
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