Early Access Programs Lead

vor 22 Stunden

Lausanne, Schweiz Axepta SA Vollzeit

My client, a global and growing pharmaceutical company is looking for their new Early Access Programs Lead to join their team in Switzerland (French or German part).

This person will act as Medical Expert and manage a long-term strategic planning of expended access programs for patients in need.

**YOUR RESPONSIBILITIES**:

- Manage expanded access with cross-functional-team to lead the access program strategy with a long term strategic planning.
- Work in close collaboration with all other departments as clinical, regulatory, market access, supply and other stakeholders to define the parameters of company sponsored EAPs that are wholly aligned to the medical strategic plan of the therapeutic area of focus (TAF).
- Participate to EAP data generation plans aligned within medical strategy
- Build & lead the global multifunctional team in charge of each managed access program including the key global stakeholders: market access, real world evidence, regulatory, CMC, Safety-Pharmacovigilance, Clinical operations, legal
- Work in close collaboration with regional & country medical leadership
- Be responsible for review and certification of clinical content for all communication (eg: medical education, medical communication, publications and KOL engagement plans )
- Participate for generating the Global Medical Strategic & implemantation
**YOUR PROFILE**:

- Doctoral degree, MD or PhD with Minimum 10 years total pharmaceutical industry experience, included at least 5 years in programs management and complex teams comprising both medical and clinical contributors.
- Experience at a global level (EU, US, Canada)
- Experience in a medical affairs role and early access programs
- Expertise and experience leading and/or developing global managed access programs for pipeline molecules in late-stage development, pre-launch and launch
- Good expertise of regulatory requirement in EU/US
- Direct experience in drug development and good understanding of development techniques
- Proven experience in and understanding of multiple regional/country markets
- Fluent in English

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