Head Management of Global Medical Evidence
Vor 2 Tagen
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.
As our Head Management of Global Medical Evidence Generation and Launch Preparation, you will be overseeing and supporting as project manager all medical evidence generation programs (Galderma sponsored and IITs) and closely interfacing with all relevant internal stakeholders (Global Medical Leads, Country Medical Representatives, Clinical Operations representatives, Clinical Experts Team etc.) and CROs.
**Responsibilities**:
- Managing, monitoring and documenting (medical dashboard):
- approval and initiation processes related medical evidence generation programs
- schedule, agenda and minutes of Core Team meetings for individual evidence generation programs
- progress (timelines, milestones, budget) of all medical evidence generation programs
- medial evidence program related metrics and KPIs
- Overseeing mitigation activities to correct deviations in timelines or budget
- Interfacing with CROs and monitoring performance
- Developing medical launch preparation guidance, sharing best medical launch practices and supporting its implementation (global, regions, countries) jointly with GBUs, Regions and Medical Learning and Capabilities
- Implementing and evolving the medical COE (Center of Excellence) for RWE and non-interventional medical studies in close collaboration with GBUs and R&D Clin. Operations
- Updating/developing global evidence generation related standards (SOPs) and guidelines, harmonized across GBUs, in close collaboration with all relevant internal stakeholders and ensuring consistency of processes (SOPs) in alignment with R&D trial governance and GCP
**Minimum Requirements**:
- 12+ years of relevant experience in Medical Affairs, 8+ years management/ leadership experience
- Experience in dermatology preferred
- Launch experience in global (or large region) and local Medical Affairs functions
- Advanced degree in a scientific discipline (e.g. PhD, PharmD, MD) with substantial multi-disciplinary and/or cross-functional project leadership experience required
- Good knowledge related to planning and execution of Medical Affairs evidence generation programs such as Phase 3b/4 Clinical Studies, interventional and non-interventional trials (RWE, pragmatic studies, registries etc.), Investigator Sponsored Studies
- Proven leadership, capacity to lead several activities and stakeholders (including external partners) to ensure value added activities/prioritization/and strategic impact
- Proven self-starter with experience in building capabilities based on defined business needs across geographies and functions; international experience desirable
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