Astellas Pharma Senior Medical Affairs Director, Women's Health 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 of Position:
The Senior Medical Affairs Director Women's Health, US, is accountable for the strategy and oversight (including implementation and execution) of all medical and scientific strategies for one or more products within the Women's Health Therapeutic Area (TA) in the US. The Sr. Medical Affairs Director is responsible for:
Driving the MA US Women's Health strategy in partnership with the Commercial Women's Health leader
Overseeing the Understand, Generate, and Share deliverables of the team (see attached)
Supervising all medical directors on the Women's Health team
representation of the US within the Core Medical Team (CMT); and
working closely with key stakeholders across the company to support business objectives.
Essential Job Responsibilities:
Accountable for all MA US Women's Health Brand Strategic Plan(s) and CMP(s)
Accountable for MA US Women's health core membership and contribution to CMT
Accountable for oversight and execution of MA-sponsored clinical studies and other phase 4 research, as applicable
Provide scientific and medical direction to develop and approve sound study synopsis, protocols and study reports, including health economic & outcomes research (HEOR) related studies
Supervise all medical directors in Women's Health, US and create and lead a healthy and productive team
Leadership of the Women's Health Brand Team, including all cross-functional medical colleagues such as Med Info, operations, HEOR, etc.
Accountable for the field Medical strategies (both MSL's and fHEOR)
Partner with the National MSL Director to ensure a strong and effective MSL team which delivers optimally for customers and the business
Represent the US Women's Health team in various leadership forums, including presentations as appropriate
Partner closely with peer colleagues in the US Commercial organization and cross-functional teams, providing strategic medical direction to support the needs of the business
Provide oversight of medical approval of promotional materials
Provide oversight of medical approval of non-promotional medical materials, including but not limited to slide presentations, local dossiers, health outcomes models, etc.
Oversight of the review and approval of all standard and custom Medical Information response letters
Provide direction and oversight for medical advisory boards within area of responsibility to understand and shape medical strategies and research
Collaborate with Regulatory Affairs and Pharmacovigilance in the development of product labeling and periodic safety reports, as applicable
Support scientific review of investigator sponsored research (ISR) proposals in the TA;
Support medical needs 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 Sr. Medical Affairs Director provides medical and scientific guidance for one or more products within the Women's Health TA including accountability for MAA product/TA strategies and execution. The Sr. Medical Affairs 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 Sr. Medical Affairs Director must be scientifically sound and in compliance with applicable regulations. The Sr. Medical Affairs Director is accountable for CMP deliverables and will demonstrate solid leadership and executive presence with both internal and external executive leaders.
The Sr. Medical Affairs Director reports to the Vice President, TA Head, US Medical Affairs, and will work within multiple cross-collaborative project teams and have matrix responsibilities across the US and broader Astellas global organization. The Sr. Medical Affairs Director will collaborate with the following colleagues:
MA: Vice Presidents, Executive Medical Directors/CMT leads, Senior Medical Directors/CMT members, Executive/Senior Director HEOR
M&D: Executive Directors; Senior Directors - including Regulatory, Pharmacovigilance and Development
Commercial/Health Systems: Executive/Senior Directors/Directors
Other: Senior leaders - Government Affairs, Legal, Ethics & Compliance, Business Development
External: Key External Experts, Executive leadership of Astellas partners, and medical organizations
Medical Degree (MD) or Medically or Scientifically Qualified with post graduate education or extensive relevant pharmaceutical medical affairs experience
Minimum 10 years of pharmaceutical industry experience
Minimum 3 years industry Medical Affairs experience
Minimum 5 years of experience supervising individuals at the director level
Experience in launching a new product in the US
Experience in collaborating with medical, clinical, regulatory, health outcomes, epidemiology, medical information, commercial and other organizational partners to deliver results
Demonstrated ability to partner effectively with Commercial leadership to develop and deliver strategic brand plans
Demonstrated ability to lead a broad cross-functional medical affairs team
Demonstrated ability to develop and implement effective strategies to achieve business results
Solid scientific analytical and problem-solving skills, project management and planning and organizational skills
Ability to communicate very 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
Experience in medical research
Experience in the Women's Health area in the pharmaceutical industry
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)
Experience in effectively engaging with customers through digital channels
Demonstrated strong interpersonal relationship and collaboration skills working within cross- functional executive leadership teams
Thorough understanding of FDA/PhRMA, OIG, 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 shut down
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