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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