Astellas Pharma Sr. Medical Director Specialty (ESMA) 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 Senior Medical Director, ESMA Team Lead opportunity in Northbrook, IL.
Purpose & Scope of Position:
The Senior Medical Director, ESMA Team Lead, Medical Affairs, TA Specialty, will be globally accountable for Medical Affairs (MA) activities for assigned rare disease, cell therapy, or regenerative medicine products in early stage development leading up to commercialization. This position will report to the Early Stage Medical Affairs, ESMA) Lead and facilitate collaboration across a matrix organization to ensure the creation and execution of the Early Stage Medical Affairs Plans for pre-POC and early post-POC pipeline products. He/she will act as Team lead for the precursor to the Med Affairs Core Medical Team (the ESMA team) and represent MA on Development Core Teams for one or more specific products and eventually transition to MA Core Medical Team Lead at the appropriate development stage. The Early Stage Medical Plans include 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 providing subject matter expertise at a detailed level.
The ESMA Team Lead will represent the ESMA Team 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 the Commercial organization's New Product Planning Group will facilitate strategic alignment of Medical and Commercial activities in advance of the Global Product Strategy Team (GPST) formation. Collaboration with Development and PPS will support candidate nomination efforts for new clinical development programs.
As a Senior Leader within Medical Affairs, the Early Stage Medical Affairs Team Lead ensures that ESMA activities for which he /she has responsibility comply with all Astellas policies and SOPs globally while assisting the ESMA-L in ensuring the optimal global allocation and management of Medical Affairs resources for the relevant products.
This position is fully accountable for timely execution of these MA deliverables within budget, and together with the ESMA-L proactively manages the risk of not meeting timelines and budget
Essential Job Responsibilities:
- Lead the development of the Early Stage Medical Affairs Plan for assigned products and be accountable for execution.
- Partner 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 to discussions with Development colleagues and ensure that MA (including HEOR) perspectives are provided and incorporated in Development plans.
- Lead or co-lead projects within MA beyond their TA.
- Draw on important key insights from the scientific community 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, budget, and tactics of two or more compounds in early stage development or early launch.
- Accountable for execution of CMP within budget within timelines. CMP budget per compound per indication which may extend as high as 5m USD.
- Chair matrix team (e.g. ESMA Team) of several colleagues for 2-4 indications/compounds with a monthly frequency
- Co-lead early global strategy efforts with New Product Planning for 2-4 indications/compounds
- The Senior Medical Director ESMA Team Lead reports to the Executive Director, Early Stage Medical Affairs Lead (ESMA-L) for the appropriate Therapeutic Area.
- collaborates with MA colleagues (Director and above) in MA Established Markets, MA International Markets, MA Japan and MA United States), Development Global Medical Leads and Global Development Product Leads at Senior Director or Executive Director level, and / or, New Product Planning (NPP), and Market Access Leads.
- 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 can 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 complex 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 Affairs budgets with demonstrated ability to apply pro-active risk management on budget and timelines.
- Medical specialty and/or experience in rare diseases, regenerative medicine, or cell therapy-- focus in ophthalmology and otolaryngology specialties are favored.
- Work experience across multiple cultures and countries / regions.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Medical Affairs