Executive Leader, Medical Information, Medical Operations
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 an Executive Medical Director Oncology opportunity in Northbrook, IL.
Purpose & Scope of Position:
The Executive Medical Director, CMT Lead, Medical Affairs TA 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, presenting and defending 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 Product Portfolio Strategy (PPS) will support clinical development programs for new indications or line extensions for assigned 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:
Accountable for the development and execution of the Core Medical Plan for assigned compounds.
Fully up to date with most recent HTA and Access needs globally for assigned products/TA; partner with HEOR lead to develop appropriate plans for addressing identified gaps and ensure Core Value Dossiers and other outputs are provided in a timely manner.
Provide external medical and business environment perspectives and TA knowledge in the development of CMPs, the business plans and Phase 3 Clinical Development Plans.
Has in-depth knowledge of Therapy Area (TA) and considered an internal expert of the TA, diseases and products. Builds and maintains relationships with global experts and be able to obtain important key scientific insights to support the TA.
Has a thorough understanding of the regulatory environment and can contribute to regulatory strategies internally and externally.
Has advanced understanding of pharmaceutical industry and role of Medical Affairs; provide guidance and expertise within Astellas.
Able to lead or co-lead projects within MA beyond their TA and manage multiple projects with a high degree of efficiency
Apply strategic thinking beyond CMT-related activities to wider issues within Medical Affairs and contribute to discussions on process optimization
Sought-out by key internal and external leaders for consultation on leading projects and initiatives that come from personal expertise and experience.
Create a One Astellas through effective leadership of matrix teams of global and functional colleagues assigned to products or TA; serves as a key force in enhancing cohesion and effectiveness of MA by fostering cross team collaboration. Resolve conflicts within a complex matrix organization without need for escalation.
Foster a culture of 100% compliance and Champions the Astellas Way
Mentor MA colleagues beyond direct reports.
Embed Compliance Culture across all Regions of the business ensuring Integrity in Action is actively applied in all initiatives and proactively address non-compliance.
Ensure adherence to Astellas policies relating to healthcare compliance standards and interactions with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs) and Patient Organizations (POs).
Responsible for Global Medical Affairs Functions to ensure a culture of Ethics and Compliance; leads by example and incorporates cross-cultural perspectives when addressing challenging situations.
Accountable for MA strategies and tactics of several 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 Executive Medical Director CMT Lead reports to the 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, 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.
Significant experience in country/region or global medical affairs, medical safety, clinical development. Substantial Medical Affairs experience.
Has in-depth knowledge of TA/disease/product and can operate across multiple 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 advanced 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. Can 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 relevant therapeutic area.
Work experience across multiple cultures and countries / regions.
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the U.S. and employs nearly 1,200 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created Changing Tomorrow Day, an annual, worldwide volunteer event, to demonstrate this commitment.