Medical Lead, ACP/Ophthalmology, Medical Affairs US
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
The Role
The Medical Lead, Medical Affairs, United States (MAUS), is accountable for the development and execution of medical and scientific strategies and tactics for avacincaptad pegol (ACP) within the Ophthalmology TA.
Responsibilities
The Medical Lead is responsible for:
Development of overall scientific and medical strategy for assigned product(s)
Creation and management of internal product/TA strategy and training strategic oversight and execution of data generation activities and other MAUS tactics
Review and endorsement of, and in some cases creation of scientific exchange materials, product launch planning/operations, and strategic congress planning, including collection and assessment of external medical insights to shape medical strategies
Representation of the US region within the Core Medical Team (CMT)
Collaboration with key stakeholders across the company to support business objectives for the US Region, leading the Regional Medical Team (RMT), if applicable, and ensuring alignment with and support of Medical Affairs (MA) colleagues within the region
Assessment of external medical environment perspectives and informing of medical strategies, including global strategies.
Essential Job Responsibilities include:
Lead the development and execution of solid strategic medical plans for the assigned products within the TA that are aligned with the global Core Medical Plan (CMP)
Accountable for oversight and execution of MA-sponsored clinical studies, as applicable
Drive scientific and medical development and approval of sound study synopsis, protocols and study reports, including health economic & outcomes research (HEOR) related studies, ensuring clinical and scientific accuracy
Align with peer leaders in the Commercial organization and cross-functional teams, providing strategic medical direction to support the needs of the business
Demonstrate ability to collaborate and lead within matrix product/TA teams across multiple disciplines
Represent MAUS on the relevant CMT, including representation of all regional needs and activities and timely execution of the CMP tactics, as appropriate
Provide medical expertise and approval of promotional materials
Provide medical expertise and approval of non-promotional medical materials, including but not limited to slide presentations, local dossiers, health outcomes models, etc.
Review and approve standard and custom Medical Information response letters
Initiate and support medical advisory boards within area of responsibility to understand and shape medical strategies
Partner with medical science liaison (MSL) team in the field, effectively translating insights into regional and global strategy
Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable
Lead scientific review of investigator sponsored research (ISR) proposals in the TA; may chair Regional ISR Committee if applicable
Provide medical expertise related to new product licensing and acquisition opportunities for the US
Foster a culture of 100% compliance and embody One Astellas and the Astellas Way
