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 Senior Medical Director, Core Medical Team Lead, Medical Affairs Global, Location, Northbrook, IL
Purpose & Scope:
The Senior Medical Director, CMT Lead, Medical Affairs Global will be globally accountable for Medical Affairs (MA) activities for assigned products, in late stage development or post-launch. This position will lead the Core Medical Team (CMT) and facilitate collaboration across a matrix organization to ensure the creation and execution of the Core Medical Plan (CMP). The CMP includes MA sponsored data generation (including Health Economics and Outcomes Research (HEOR)) that addresses existing and future data gaps and supports reimbursement needs, a Publication Plan, Medical Tools and other MA tactics.
This position is also responsible for leading routine and ad-hoc assessments of the Benefit/Risk of assigned products. The CMT Lead will represent the CMT perspective at meetings with Astellas senior leadership (e.g. Global Benefit Risk Committee (GBRC), Medical Affairs Committee (MA-C)) and at relevant other meetings if applicable. Interaction with Marketing Strategy, through co-leading Global Product Strategy Team (GPST), will lead to the creation and execution of an integrated Global Brand plan (iGBP). Collaboration with Development and PPS wil support clinical development programs for new indications or line extensions for marketed products.
As a Senior Leader within Medical Affairs the CMT Lead provides overall global vision and direction for the medical strategy and ensures that CMT activities comply with all Astellas policies and SOPs globally and is accountable for the optimal allocation and management globally of Medical Affairs resources for the relevant products.
This position is fully accountable for timely execution of these MA deliverables within budget, and proactively manages the risk of not meeting timelines and budget.
Essential Job Responsibilities:
- Lead the development of the Core Medical Plan for assigned products and accountable for execution.
- Support the creation and delivery of scientific and medical content for product level training internally and externally.
- Partners with HEOR lead to drive HEOR gap analysis, and ensure projects to address these gaps are reflected in the CMP and support the creation of the Core Value Dossiers and outer outputs needed to support Access.
- Provide support in coordinating medical activities at medical and scientific conferences.
- Contribute in discussions with Development colleagues and ensure that MA (including HEOR) perspectives are provided and incorporated in Development plans.
- Able to lead or co-lead projects within MA beyond their TA.
- Build and maintains relationships with global experts and able to obtain important key scientific insights to support the TA.
- Effectively lead matrix teams of global and functional colleagues; ensure effective cross-regional and cross-functional collaboration; align all key MA projects globally for assigned product and indication. Champion an objective and evidence-based solution oriented approach
- Promote the Astellas Way.
- Accountable for MA strategies and tactics of one or more compounds in late stage development or early launch.
- Accountable for execution of CMP within budget within timelines. CMP budget per compound per indication may range from 5m to 25m USD.
- Chair matrix team (e.g. Core Medical Team) of up to 10-15 colleagues for 2-4 indications/compounds with a monthly frequency
- Co-chair the Global Product Strategy Team for 2-4 indications/compounds
- The Senior Medical Director CMT Lead reports to the TA Head for the appropriate Therapeutic Area.
- Collaborates with MA colleagues (Director and above) in MA EMEA, MA Asia Oceania, MA Japan and MA Americas), Development Global 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 5years total industy experience including country/region or global medical affairs, medical safety, or clinical development. At least 3years Medical Affairsexperience.
- 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.
- Experience in successfully leading cross-regional and cross-functional matrix teams either within Medical Affairs or clinical development. The ability to influence without direct authority is a critical skill set for this role.
- Demonstrates complex problem solving skills and ability to manage more comples problems within TA or product teams.
- Has full understanding of 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.
- Experience in managing large Medical Affairsbudgets with demonstrated ability to apply pro-active risk management on budget and timelines.
- Medical specialty and/or experience in relevant therapeutic area.
- Work experience across multiple cultures and countries / regions.