Medical Lead Oncology MA-US NSCLC

Medical Lead Oncology, MA-US (NSCLC)

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

The Medical Lead Oncology, MA-US (Medical Affairs-United States), is accountable for the development and execution of medical and scientific strategies for one or more products within the Therapeutic Area (TA).

The Medical Lead Oncology, MA-US 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 MA-US 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 Medical Affairs Team (MAT), as applicable
• collaboration with key stakeholders across the company to support business objectives for the US Region, leading the Regional Medical Team (RMT), as 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.

Role and Responsibilities

• 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)
• Lead external engagement with lung cancer experts, key opinion leaders, and professional organizations to generate actionable insights, shape medical strategy, and foster scientific collaboration.
• 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 MA-US on the relevant MAT, including representation of all regional needs and activities and timely execution of the CMP tactics, as applicable
• 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 all 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, as 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