Medical Director Oncology, Medical Affairs, United States (MA-US)
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.
Astellas is announcing a Medical Director Oncology, Medical Affairs, United States (MA-US) opportunity in Northbrook, IL. 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 Medical Director Oncology, Medical Affairs, United States (MA-US), is accountable for the development and execution of medical and scientific strategies for one or more products within the Therapeutic Area (TA).
The Medical Director is responsible for:
development of overall scientific and medical strategy for assigned product(s)
creation and management of internal product/TA strategy and training
strategic oversight and execution of data generation activities and other MA-US tactics
review and endorsement of, and in some cases creation of scientific exchange materials, product launch planning/operations, and strategic congress planning, including collection and assessment of external medical insights to shape medical strategies
representation of the US region within the Core Medical Team (CMT)
collaboration with key stakeholders across the company to support business objectives for the US Region, leading the Regional Medical Team (RMT), if applicable, and ensuring alignment with and support of Medical Affairs (MA) colleagues within the region
assessment of external medical environment perspectives and informing of medical strategies, including global strategies.
Essential Job Responsibilities:
Lead the development and execution of solid strategic medical plans for the assigned products within the TA that are aligned with the global Core Medical Plan (CMP)
Accountable for oversight and execution of MA-sponsored clinical studies, as applicable
Drive scientific and medical development and approval of sound study synopsis, protocols and study reports, including health economic & outcomes research (HEOR) related studies, ensuring clinical and scientific accuracy
Align with peer leaders in the Commercial organization and cross-functional teams, providing strategic medical direction to support the needs of the business
Demonstrate ability to collaborate and lead within matrix product/TA teams across multiple disciplines
Represent MA-US on the relevant CMT, including representation of all regional needs and activities 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
Initiate and support medical advisory boards within area of responsibility to understand and shape medical strategies
Partner with medical science liaison (MSL) team in the field, effectively translating insights into regional and global strategy
Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable
Lead scientific review of investigator sponsored research (ISR) proposals in the TA; may chair Regional ISR Committee if applicable
Provide medical expertise related to new product licensing and acquisition opportunities for the US
Foster a culture of 100% compliance and embody One Astellas and the Astellas Way
The Medical Director provides medical and scientific guidance for one or more products within the TA including accountability for MA-US product/TA strategies and execution. The Medical Director is part of a high performing medical team with direct budget responsibilities of to $10M annually, including 5-10 data generation projects and 10 medical tools annually. The results produced by the Medical Director must be scientifically sound and in compliance with applicable regulations. The Medical Director is accountable for CMP deliverables within timelines and budget and will demonstrate solid leadership and executive presence with both internal and external executive leaders.
Medical Degree (MD)
Minimum 3-5 years clinical experience beyond medical school
Minimum 2 years Medical Affairs relevant experience within the pharmaceutical industry, or minimum 3 years clinical or academic experience after residency training
Experience in the US
Experience in working in matrix organization collaborating with medical, clinical, regulatory, health economic & outcome research, epidemiology, medical information, commercial and other organizational partners to deliver results
Solid scientific analytical and problem-solving skills, strategic capabilities, project management and planning and organizational skills
Ability to communicate effectively, including scientific concepts, both in writing and in oral presentations
Ability to design and conduct various phases of clinical trials, including ability to critically review and analyze study designs
Ability to collaborate within matrix structured product team across multiple disciplines
Ability to effectively engage both internal and external stakeholders, customers and collaboration partners.
Demonstrated ability to collaborate and build strategic alignment within the Medical Affairs community and across functions (e.g., Commercial).
Fluent in written and verbal English
Approximately 20% travel required
Minimum 2 years Medical Affairs relevant experience within the pharmaceutical industry
Medically Qualified with post graduate qualification and specialization in appropriate therapeutic specialty preferred
Board Certified in relevant therapeutic area
Active medical license
Experience in medical research
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, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
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 - USA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans