Global Precision Medicine Lead, Companion Diagnostics

Global Precision Medicine Lead

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 ~~~ .

This position is based in Ontario, Canada. 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 and Scope:

The Global Precision Medicine Lead role is responsible for the development and execution of biomarker and diagnostic strategies across drug development programs to develop tailored therapies that drive improved patient outcomes. The primary responsibility of a Global Precision Medicine Lead is to bring companion diagnostics through development to approval in collaboration with external diagnostic partners for Oncology and/or Gene Therapy. The role requires strong knowledge and experience in applied biomarker research and companion diagnostics development together with strong personal drive to deliver innovative solutions.

Essential Job Responsibilities:

• Participates in the development and execution of precision medicine and diagnostic strategies for early and late-stage clinical development programs in oncology and other therapeutic areas.

• Contributes to the design of clinical studies that incorporate patient stratification, enrichment and biomarker testing including contribution to the relevant sections of study and regulatory documentation.

• Enhances drug success in early development through the implementation of precision medicine strategies to define the relationship between biomarkers and drug efficacy and safety.

• Facilitates biomarker testing of patient samples and interprets biomarker data from clinical studies to inform precision medicine and diagnostic strategies and generate data to support health authority submissions.

• Leads the evaluation and selection of diagnostic technologies and external diagnostic partners to support drug development programs.

• Leads the integration of companion diagnostic studies with drug clinical studies from development to approval through close collaboration with cross-functional teams and external diagnostic partners and vendors.

• Ensures compliance with regulatory requirements for diagnostic tests and precision medicine approaches implemented in clinical studies.

• Represents development as a subject matter expert on cross-functional diagnostic core teams for late-stage assets to drive successful diagnostic launches.

• Supports publication of data from precision medicine research studies.

Qualifications Required:

• Advanced science degree (PhD, PharmD or MD) in a relevant scientific field.

• At least 5 years relevant experience and proven track record in the application of biomarkers and precision medicine in drug development at a biotech/pharmaceutical company.

• Solid understanding of clinical development strategies, clinical study design and companion diagnostic development is required.

• Experience in leading the implementation and interpretation of biomarker /diagnostic testing in clinical studies is required.

• Experience working in cross functional matrixed work environments is essential.

• Excellent communication, project management and leadership skills.

Preferred:

• Experience in the registration of companion diagnostics and pharmaceuticals is preferred.

• Strong knowledge of the process and global regulations for companion diagnostic development, approval and launch.

Working Environment:

• 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.

Benefits:

• 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

• RRSP 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

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Category Precision Medicine and Diagnostics

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans