12 ago
|
Novartis Pharma Schweiz
|
Santa Marta
12 ago
Novartis Pharma Schweiz
Santa Marta
Major Accountabilities
- Providing 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 Integral 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.
Minimum Requirements
- 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 10 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 is required.
- Working knowledge
📌 Senior* Clinical Development Medical Director (Santa Marta)
🏢 Novartis Pharma Schweiz
📍 Santa Marta