Companion Diagnostic Lead, Associate Director

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Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Companion Diagnostic Lead in our Cambridge office.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver

Better Health and a Brighter Future

to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.OBJECTIVES:The Oncology Companion Diagnostics (CDx) Lead role is an exciting new opportunity within the growing Precision and Translational Medicine (PTM) function in the Oncology Therapeutic Area Unit (OTAU) at Takeda. The primary focus of this role will be to lead the R&D efforts around CDx strategy development and execution for early-stage Oncology CDx programs. Key responsibilities include leading the development and delivery of diagnostic workplans, ensuring efficient and effective test development and deployment in a global clinical trial setting, interfacing with key internal stakeholders and external diagnostic partners, and supporting health authority meetings and regulatory submissions (PMAs etc). This role will partner closely with key functions across Takeda Oncology including Translational Medicine, Clinical, Sciences, Global Regulatory Affairs, the Oncology Business Unit (Commercial and Medical Affairs), Alliance Management, Business Development, and clinical biomarker technologies.The level of the position will be determined based on the skills and experience of the candidate.ACCOUNTABILITIES:Lead cross-functional team to ensure effective development and implementation of diagnostic strategies supporting oncology programs, including follow-on and region-specific workstreams.Drive technical assessment of assay/device analytical and clinical validation.Identify appropriate companion diagnostic partners, contribute to partnership negotiations, ensure the development of high-quality work plans and data packages.Work with external diagnostic partners to develop, file, and launch CDx/devices globally in alignment with therapeutic program development and commercial objectives.Support BD initiatives and due diligence teams.Contribute to the development of global diagnostic regulatory submissions, respond to health authority questions, and review labeling documents.Function as a scientific and technical R&D thought leader at Takeda for diagnostic development and commercialization.EDUCATION AND EXPERIENCE:PhD in cancer biology, genetics, molecular biology, pathology or related field with 3+ years of experience or a MS with 5+ years of experience in the pharmaceutical, biotech or diagnostic industry.Oncology experience required.Experience in developing and delivering companion diagnostic work plans, assessing assay/device validation data packages, and supporting regulatory submissions.Successful track record leading CDx/in vitro diagnostics (IVD) development programs.Experience with diagnostic submissions with international health authorities desired.Experience working with external diagnostic partners required.Precision medicine strategy development experience.Histopathology technical and landscape domain knowledge would be ideal, understanding of other technology platforms (PCR, genomic, immunoassays…etc) desirable.Experience working with drug development teams to understand diagnostic needs and develop strategic diagnostic plans desired.SKILLS:Excellent communication (written and oral) skills.Excellent strategic, interpersonal, influence, and negotiating skills.Demonstrated ability to work effectively across functions, projects, and time zones and with external partners.Ability to assemble and motivate cross-functional stakeholders and drive results.Capable of proactively predicting issues and solving problems with agility.Ability to drive decision-making within multi-disciplinary, multi-regional, matrix teams.Ability to drive multiple priorities forward simultaneously.KNOWLEDGE:Advanced knowledge of diagnostic development including analytic and clinical validation, drug development, oncology therapeutic area, precision medicine approaches in clinical development.Understanding of medical device and clinical laboratory requirements.TRAVEL REQUIREMENTS:Ability to drive to or travel to conferences, partner meetings, including overnight trips. Some international travel may be required.Requires approximately 10 - 15% travel.Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.Locations

Boston, MAWorker Type

EmployeeWorker Sub-Type

RegularTime Type

Full time

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