Global Medical Affairs Director at ViiV Healthcare ensuring effective communication of HIV prevention research. Leading training and data compliance efforts for clinical specialists and outside health care providers.
About the role
- Senior Clinical Development Medical Director responsible for managing clinical programs in the Renal Therapeutic Area. Lead execution of strategic plans and clinical development responsibilities across assigned programs.
Responsibilities
- leading the strategic planning and management of the assigned clinical program(s)
- oversight of the clinical development for the assigned programs
- driving execution of the clinical development plan
- clinical leadership and strategic medical input for all clinical deliverables
- 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
- supporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule
- providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP)
- supporting interactions with external and internal stakeholders
Requirements
- MD or equivalent medical degree
- clinical practice experience 4 years (including residency)
- 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
- 2 years of contribution to and accomplishment in all aspects of conducting clinical trials
- Working knowledge of disease area is required
- proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s)
- 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
Benefits
- Novartis Life Handbook
- Accessible and reasonable accommodation
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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