Astellas Pharma Medical Director TA Oncology in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Medical Director, TA Oncology opportunity.
Purpose & Scope of Position:
The Medical Director, Medical Affairs provides expert scientific and medical input for assigned products, in late stage development or post-launch. This position supports the Core Medical Team Lead (CMTL) and collaborates across a matrix organization to ensure the effective planning, monitoring and execution of the Core Medical Plan (CMP). The CMP includes activities to; a) understand external environmental and data gaps, b) fulfill information needs of external stakeholders such as data generation for HCPS and Payers, data communication and Medical education and c) Training MA workforce. The specific activities include the following but not limited to Advisory Board Engagements , HTA Scientific Strategy and Advice, MA sponsored data generation (including Health Economics and Outcomes Research (HEOR), that addresses existing and future data gaps and supports reimbursement needs, Investigator Sponsored Research, Scientific Publication Plan, Medical Tools and other MA tactics.
Further the Medical Director within the CMT pprovides input to the help develop the overall global vision and direction for the medical objectives and strategies and actively supports and collaborates with the Co-Creation of the integrated Global Brand Plan (iGBP).
This position shares responsibility with other CMT members for timely execution of these MA deliverables within budget, and proactively manages the risk of not meeting timelines and budget.
Where Astellas, has Medical Affairs collaboration agreement with a partner, the Medical Director supports the CMT Lead with the Medical Affairs activities throughout the designated committee (i.e. Joint Medical Affairs Committee).
Essential Job Responsibilities:
Contribute to the development of the Core Medical Plan for 1-2 products per TA and shares responsibility for planning, monitoring and execution.
Support the creation and delivery of product level training (internally and externally)
Collaborate with the HEOR team to drive HEOR gap analysis and ensures projects to address these gaps are reflected in the CMP and support the creation of the Core Value Dossiers and other outputs needed to support Access.
Provide support in coordinating medical activities at medical and scientific conferences.
Collaborates and supports the publication plan.
Build and maintain relationships with global experts and be able to obtain important key scientific insights to support the TA.
Has a solid understanding of the regulatory environment and is able to contribute to regulatory strategies for the product.
Actively supports and collaborates with the Co-Creation of the integrated Global Brand Plan (iGBP).
May contribute to projects within MA beyond their TA.
Support effective cross-regional and cross-functional collaboration; help align all key MA projects globally for assigned product and indication and understand and embrace the elements of the Astellas Way.
Work effectively within a complex matrix organization and know when escalation is required
Supports medical strategies and tactics of one or two compounds in late stage development or early launch.
Shares responsibility for execution of CMP within budget within timelines. CMP budget per compound per indication may range from 5m to 25m USD.
The Medical Director reports to the CMT Lead (Executive Director) or TA Head for the appropriate Therapeutic Area.
Collaborates with MA colleagues (Director and above) in MA Established Markets, MA International Markets, MA Japan and MA US), Global Development Medical Leads and Global Development Product Leads at Senior Director or Executive Director level, Development TA Heads and Marketing Strategy (MS) Brand Director and TA Heads.
Collaborates with peers in other functions in Medical and Development (M & D) e.g. PV and RA, at all levels.
Interacts with key external scientific and clinical experts, industry thought leaders, and may interact with collaboration partners.
Medical Degree (MD). Holds an appropriate medical degree and certification recognized by one of the leading medical governing bodies from around the globe.
At least 5 years total industry experience including country/region or global medical affairs, medical safety, or clinical development. At least 3 years Medical Affairs experience.
Has good knowledge of TA/disease/product and is able to operate across several products within TA. Able to effectively communicate knowledge (TA/disease/product) to others.
Aware of relevant rules and regulations in pharma, including knowledge of global regulatory bodies and procedures, as well as anti-kickback laws, which could have impact for the pharmaceutical industry. Appropriate knowledge of guidelines and regulations such as IFPMA (International Federation of Pharmaceutical Manufacturers Association), PhRMA (Pharmaceutical Research and Manufacturers of America), FDA, EMA, PMDA, ACCME and OIG. Is able to apply legal and compliance knowledge to Medical Affairs activities.
Fluent in written and verbal business English.
Medical specialty and/or experience in relevant therapeutic area
Experience in working within cross-regional and cross-functional matrix teams either within Medical Affairs or clinical development. Work experience multiple cultures and countries/regions.
Category Medical Affairs
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans