Vice President, Global Medical Affairs job in Cranbury
|Employer:|| Amicus Therapeutics|
|State:||New Jersey (NJ)|
Vice President, Global Medical Affairs
The Vice President, Global Medical Affairs will build and manage the Medical Affairs team, closely leading and overseeing medical strategy, project execution, early access programs, Investigator Initiated Programs (IIP), publications, medical information, medical education, Phase 4 post-marketing research and medical communications for all Amicus medicines. The Vice President, Global Medical Affairs will be responsible for providing medical insight, guidance, strategy, medical review, and training as needed to Medical Affairs and to senior management and will work with Market Access teams to develop compelling medical evidence to support optimal patient access to medicines. He/she will oversee the development of the regional Medical Affairs strategies across all Amicus products.
The Vice President, Global Medical Affairs will represent Amicus in scientific presentations, conferences and industry groups; serve as lead spokesperson with KOLs and interact with various Government agencies globally, and support optimal life- cycle management. He/she will partner with the Compliance and Legal Departments to ensure that all Medical Affairs activities are conducted in a manner that is compliant with Amicus policies, procedures, and local regulatory/legal requirements.
Roles and Responsibilities
- Build and lead the Global Medical Affairs organization, setting the strategic direction of all Medical Affairs functions across the Amicus organization.
- Ensure and oversee the development of clear and well communicated medical strategies for each Amicus product that can be used to guide development of robust Medical Plans that meet the needs of local markets.
- Represent and manage Amicus clinical programs in working with the Regulatory and Reimbursement agencies. Build partnerships and relationships with the scientific and medical community. Represent Amicus externally in scientific presentations, conferences and industry groups.
- Oversee the interpretation, publication/public disclosure, and accurate use of scientific data concerning migalastat in Fabry disease and ATB200 in Pompe disease (as well as future products), and oversee the development of scientific content for medical communication and scientific education initiatives.
- Oversee the planning, development, execution and reporting of all Phase 4 post-marketing research. Ensure there is robust governance and that all Phase 4 research is conducted in a compliant way and to the highest ethical standards and scientific rigor.
- Provide strategic input into the development of Phase 3b & 4 studies in collaboration with other stakeholders.
- Chair the Global IIP Review Committee.
- Interact with key members of the medical community to assist in understanding current practice issues for Fabry and Pompe disease, including developing and maintaining effective and optimal relationships with Key Opinion Leaders.
- Form and enhance working relationships with key external research collaborative groups.
- Actively participate and ensure Medical Affairs contributions to various teams and taskforces to build and support the Amicus portfolio in all facets of the business, with an emphasis on:
- Pricing and reimbursement
- Lifecycle management
- Partner with the Compliance and Legal Departments to ensure that appropriate systems and SOP/processes are in place to meet all regulatory/legal requirements related to Medical Affairs.
- Serve as an ethics and compliance role model for the Medical Affairs function and broader Amicus community.
- Drive a high performance culture by fostering innovation, collaboration, customer focus, personal accountability and a commitment for results.
- Lead Amicus medical strategies and project execution that support clinical development, including trial design and recruitment, early access initiatives, investigator initiated research/studies (IIRs/IISes), publications and other medical communications (e.g., medical information system, call center, etc.)
- Provides medical insights and guidance including strategy, medical review, competitive intelligence and training for key commercial projects and business development opportunities.
- Works closely with commercial team to develop compelling medical evidence to support optimal patient access to our medicines.
- Works closely with Patient & Professional Advocacy to support patient-centric activities.
- Works with headquartered and field-based medical teams to grow and manage a thought leader network to support successful implementation of plans.
- Ensures safe and appropriate use of Amicus medicines.