Astellas Pharma Senior Medical Director TA Oncology in Northbrook, Illinois
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose & Scope:
The Senior Medical Director, Medical Affairs, US (MAUS), is accountable for the development, execution and oversight of medical and scientific strategies for one or more products within the Therapeutic Area (TA). The Senior Medical Director is responsible for:
Proactive assessment of external medical environment perspectives that shape global medical strategies
Overall strategy and execution of data generation activities that clearly demonstrate product value and are aligned with global strategies
Review and approval of scientific exchange materials
Internal product/TA training content strategy
Representation of the US region within the Core Medical Team (CMT)
Working closely with key stakeholders across the company to support business objectives for the US Region, leading the Regional Medical Team (RMT) and ensuring alignment with and support of Medical Affairs (MA) colleagues within the US.
Essential Job Responsibilities:
Drive and oversee the development and execution of robust US strategic medical plans for the assigned products within the TA that are aligned with the global Core Medical Plan (CMP)
Provide scientific and clinical expertise to develop and approve high-quality study synopsis, protocols and study reports, including Health Economic & Outcomes Research (HEOR) related studies, utilizing clear understanding of life cycle management, portfolio strategy and competitive landscape across disease area
Accountable for oversight and execution of MA-sponsored clinical studies within area of responsibility
Sought out by internal and external stakeholders as an expert on matters relating to the TA, including external medical insights and mentoring/training of colleagues across the TA
Align closely with peer colleagues in the Commercial organization and leads/co-leads cross functional teams, providing strategic medical direction to support the needs of the business
Effectively lead and influence within matrix product and TA-related teams
Work closely with and provide medical direction to Medical Science Liaison leadership team
Represent MAA on the relevant CMT, including representation of all regional needs and activities (United States, Canada, Latin America) and timely execution of the CMP tactics
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 and overall product response strategy
Initiate and chair medical advisory boards to understand and shape medical strategies
Develop strategy and drive rigorous scientific review of investigator sponsored research (ISR) proposals and where applicable serve as Chair of the US ISR Committee
Provide medical expertise and input for new product licensing and acquisition opportunities that shapes evaluations for the US.
Foster a culture of 100% compliance and embody One Astellas and the Astellas Way
The Senior Medical Director provides medical and scientific leadership for one or more products within the TA including accountability for MAA product/TA strategies and execution. The Senior Director is part of a high performing medical team with direct budget responsibilities of up to $10M annually, including 5-10 data generation projects and up to 10 medical tools annually. The results produced by the Senior Director must be scientifically sound and in compliance with applicable regulations. The Senior Director is accountable for CMP deliverables within timelines committed and within budget and will demonstrate effective leadership and executive presence with both internal and external executive leaders.
The Senior Medical Director reports to the Vice President, TA Head, MAA and will work within multiple cross-collaborative project teams and have matrix responsibilities across the US region and broader Astellas global organization. The Senior Director will collaborate with the following colleagues:
MA: Vice Presidents, Senior Director/Director, CMT leads, CMT members, HEOR, Field Medical Leaders
M&D: Vice Presidents, Senior Director/Director including Regulatory, Pharmacovigilance, Statistics and Development
Commercial/Health Systems: Vice Presidents, Senior Director/Director
Other: Government Affairs, Legal, Ethics & Compliance, Business Development
External: Key External Experts, Executive leadership of Astellas partners, and medical organizations
Medical Degree (MD) with 5+ years clinical practice or related experience beyond medical residency
5+ years Medical Affairs relevant experience
Demonstrated success as a Medical Director or comparable role, including development and execution of medical strategies and plans
Proven leadership working within a matrix environment to collaborate with senior leaders and drive corporate objectives
Experience in working in matrix organization collaborating with other medical functions, clinical, regulatory, health economic and outcome research, medical information, and other cross functions to deliver results
Strong scientific, analytical and problem-solving skills, strategic capabilities, project management and planning
Expertise in understanding interface between clinical practice and MA-sponsored research
Ability to communicate effectively, including complex scientific concepts, both in writing and in oral presentations
Demonstrated ability to design and conduct various phases of clinical trials, including ability to critically review and analyze study designs
Fluent in written and verbal English
Approximately 20% travel required
Minimum 3-5 years Medical Affairs relevant experience within the pharmaceutical industry
Medically Qualified with post graduate qualification and specialization in appropriate therapeutic specialty preferred
5+ years clinical experience
Active Licensure to practice medicine
Demonstrated ability in successfully supervising individuals
Experience in clinical development
Extensive knowledge of US healthcare delivery systems (e.g. accountable care, managed care, pharmacy benefit management, government [Medicare, Medicaid]) and solid understanding of policy issues)
Demonstrated strong interpersonal relationship and collaboration skills working within cross functional executive leadership teams
Thorough understanding of FDA/PhRMA, OIG, Health Canada/Innovative Medicines Canada, ANVISA/ANS and other guidelines as they relate to HEOR and Medical Affairs
Medical, Dental and Vision insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays, including year-end shutdown
401(k) Match and Annual Company Contribution
Company Paid Life Insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
Category Medical Affairs
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans