Precision Medicine Global MA Lead
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
This position is based in the UK.
This position is hybrid and will require you to be onsite once per quarter in our local office.
Astellas’ Responsible Flexibility Guidelines Statement - At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
- Global Precision Medicine (PM) lead, directly reporting to the Precision Medicine, MA Global Strategy Lead, will be accountable for the Medical Affairs support of biomarker and CDx for the relevant products both in the Early Stages of Development and pre/post launch phases.
Role and Responsibilities
- Supporting the development of effective medical and scientific CDx/Biomarker strategies for oncology products for the relevant products both in the Early Stages of Development and pre/post launch phases, and successful implementation of CDx tactics including:
- Strategic oversight and support of data generation activities and other MA tactics related to the CDx/PM
- Collaboration with key stakeholders to support CDx/diagnostic business and medical objectives.
- Assessment of external medical environment perspectives and information on global/regional medical CDx/PM strategies.
- Identify and engage with pathologist KEES/Pathology organizations for insight generation, study collaboration and education on asset/test to support testing adoption/implementation and accuracy.
- Support CDx and Biomarker evidence generation activities and publications for TA compounds
- Support execution of internal and external medical education needs for CDx of TA products in new disease areas/innovative treatment modalities with biomarker and CDx requirements.
- Provide external medical and business environment perspectives to regional MA CDx/PM strategies and processes; share and implement new insights on evolving CDx implementations in TA.
- Support relationships with Diagnostic partners, testing labs and KEEs in the Diagnostics field.
Continue: Role and Responsibilities
- Support 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.
- Provide medical diagnostic expertise and review of non-promotional medical materials, including but not limited to slide presentations, local dossiers, health outcomes models, etc.
- Support regional medical advisory boards to understand and shape medical strategies.
- Support training, planning, and executing CDx and Biomarker related launch plans, Core Medical Plan (CMP) and related tactics.
- Collaborate with counterparts in Development, Commercial and RA to implement CDx tactics for the TA portfolio.
Required Qualifications
- MD, PhD, or PharmD or equivalent
- Previous Medical Affairs CDx development experience working in the pharmaceutical industry or diagnostic company, commercial laboratory or academic experience following residency training.
- Relevant leadership experience leading CDx/PM activities within a Pharma or diagnostic organization.
- Ability to design and conduct various phases of clinical trials, including the ability to critically review and analyse study designs.
- Strong understanding of industry trends, the regulatory environment, as well market access paths for companion diagnostics.
- Experience in working in global matrix organizations 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
- Fluent in written and verbal business English.
Preferred Qualifications
- Medical specialty and/or experience in relevant therapeutic/CDx area.
- Work experience across multiple cultures and countries / regions.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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