Switzerland – Rotkreuz
Amgen is one of the world’s leading independent biotechnology companies. For nearly 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
We are currently seeking a Medical Director for our Swiss affiliate located in Rotkreuz, Switzerland. The primary focus of the successful candidate will be to provide medical and scientific leadership to regional and country leadership team in order to shape and execute strategy. Additional objectives of this role are to develop and execute local scientific communication and engagement strategy and lead local medical governance.
Additional responsibilities include:
- Lead affiliate as a member of the Affiliate Management Team
- Provide scientific/medical input into cross functional strategy, within the country Management Team.
- Manage and allocate Medical budget and resources.
- Provide scientific/medical input into local regulatory/reimbursement/policy related documents and interactions.
- Support the Global and Regional commercialization process, in partnership with Regional Medical Leads, to ensure an active flow of local medical insights and needs to the Regional and Global level.
- Provide local oversight (according to Humanforschungsgesetz (HFG) and Humanforschungsverordnung (HFV)) of clinical trial conduct in support of global Evidence Generation Plan.
- Swiss sponsor representative for correspondence with Swissmedic related to Amgen sponsored studies
- Lead the local evidence generation strategy and execution, including Investigator Sponsored Studies and expanded access.
- Lead medical advocacy and interactions with key external stakeholders as a senior medical representative of Amgen.
- Leverage local medical insights to best inform cross functional strategy.
- Ensure human subject safety in partnership with responsible functions (eg, GRAAS, Global Development).
- Support local risk management/minimization in collaboration with GRAAS.
- Medical Doctor
- 8+ years of medical affairs experience or clinical development experience with deep understanding of medical affairs, 5 years of which should be from a pharmaceutical or biotechnology company
- Track record of leadership
- International and/or global experience
- Pharmaceutical product development, product lifecycle and commercialization process knowledge with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs
- Therapeutic areas knowledge
- Network of customer contacts in therapeutic area
- Knowledge of Swiss pharmaceutical industry and legal/health system environment (e.g. Pharmakodex, Arzneimittelwerbeverordnung, Humanforschungsgesetz, Heilmittelgesetz)
- Finance/budgeting and resource management experience
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