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Clinical and Development Director
2 months ago
We are seeking a highly skilled Clinical Development Medical Director to join our team at Novartis Farmacéutica. As a key member of our Global Health R&D team, you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.
Your Key Responsibilities- Provide clinical leadership and medical strategic input for deliverables in the assigned project/program, including sections of individual protocols, data review, program-specific standards, and clinical components of regulatory documents.
- Drive execution of the section of the program in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates.
- Oversee medical and scientific review of trial data with Clinical Scientific Expert(s) and may function as study medical monitor.
- Support the Therapeutic Area Head by providing medical input into IDP and CTP reviews and contributing to the development of disease clinical standards for disease areas.
- Collaborate with NIBR and Translational Medical Sciences to drive the transition of pre-PoC projects to DDP and with BD&L on target identification and due diligence.
- Ensure career development of Program reports and clinical colleagues through active participation in performance management and talent planning processes.
- MD (or equivalent medical degree) is required.
- 5+ years' experience in clinical research or drug development from the pharma/biotech industry spanning clinical activities in Phases I through IV.
- 3+ years of contribution to and accomplishment in all aspects of conducting clinical trials in a global/matrix environment.
- Expertise and experience in anti-infective drug development are desirable.
- Demonstrate ability to establish strong scientific partnerships with key partners.
- Need thorough knowledge of GCP, trial design, statistical analysis methodology, and regulatory/clinical development process.
- Have people management experience preferred, including management in a matrix environment.
Novartis Farmacéutica is committed to building diverse teams, representative of the patients and communities we serve. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
