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Astellas Pharma Senior Medical Affairs Director, Women's Health 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 Affairs Director, Women's Health opportunity.

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

Quantitative Dimensions:

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.

Organizational Context:

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

Required Qualifications:

  • 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

Preferred Qualifications:

  • 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

*LI-CH1

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Medical Affairs

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