Astellas Pharma
Precision Medicine Global MA Lead
The Director/Senior Director, Global Precision Medicine lead is responsible for the Medical Affairs support of biomarker and companion diagnostics (CDx) for oncology products across early development and pre/post launch phases. This role involves strategic oversight of data generation, collaboration with stakeholders, and implementation of CDx tactics to support medical and business objectives globally.
Key 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
- • 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
- • 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
- • MD, PhD, or PharmD
- • Minimum 5 years of Medical Affairs CDx development experience working in the pharmaceutical industry or minimum 5 years of diagnostic company, commercial laboratory or academic experience following residency training
- • Minimum 3 years 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
- • Medical specialty and/or experience in relevant therapeutic/CDx area
- • Work experience across multiple cultures and countries / regions
Benefits & Perks
- • 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
- • Company-paid fleet vehicle for eligible positions
- • Referral bonus program
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. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
Purpose
The Director/Senior Director, 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
Essential Job 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:
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.
Salary Range: $197,400-$391,600 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience, and organizational equity considerations).
Benefits
Category MA Global Brand Strategy
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply.
Purpose
The Director/Senior Director, 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
Essential Job 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.
- 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.
- MD, PhD, or PharmD
- Minimum 5 years of Medical Affairs CDx development experience working in the pharmaceutical industry or minimum 5 years of diagnostic company, commercial laboratory or academic experience following residency training.
- Minimum 3 years 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.
- Medical specialty and/or experience in relevant therapeutic/CDx area.
- Work experience across multiple cultures and countries / regions.
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.
Salary Range: $197,400-$391,600 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience, and organizational equity considerations).
Benefits
- 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
- Company-paid fleet vehicle for eligible positions
- Referral bonus program
Category MA Global Brand Strategy
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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