Takeda Pharmaceuticals
Companion Diagnostic Lead, Associate Director
Takeda Pharmaceuticals, Boston, Massachusetts, us, 02298
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, Associate Director 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.ACCOUNTABILITIES:Lead cross-functional team to ensure effective development and implementation of diagnostic strategies supporting oncology programs, including follow-on and region-specific workstreamsDrive technical assessment of assay/device analytical and clinical validationIdentify appropriate companion diagnostic partners, contribute to partnership negotiations, ensure the development of high-quality work plans and data packagesWork with external diagnostic partners to develop, file, and launch CDx / devices globally in alignment with therapeutic program development and commercial objectivesSupport BD initiatives and due diligence teamsContribute to the development of global diagnostic regulatory submissions, respond to health authority questions, and review labeling documentsFunction as a scientific and technical R&D thought leader at Takeda for diagnostic development and commercializationEDUCATION AND EXPERIENCEPhD 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 industryOncology experience requiredExperience in developing and delivering companion diagnostic work plans, assessing assay/device validation data packages, and supporting regulatory submissionsSuccessful track record leading CDx / in vitro diagnostics (IVD) development programsExperience with diagnostic submissions with international health authorities desiredExperience working with external diagnostic partners requiredPrecision medicine strategy development experienceHistopathology technical and landscape domain knowledge would be ideal, understanding of other technology platforms (PCR, genomic, immunoassays…etc) desirableExperience working with drug development teams to understand diagnostic needs and develop strategic diagnostic plans desiredSKILLSExcellent communication (written and oral) skillsExcellent strategic, interpersonal, influence, and negotiating skillsDemonstrated ability to work effectively across functions, projects, and time zones and with external partnersAbility to assemble and motivate cross functional stakeholders and drive resultsCapable of proactively predicting issues and solving problems with agilityAbility to drive decision-making within a multi-disciplinary, multi-regional, matrix teamsAbility to drive multiple priorities forward simultaneouslyKNOWLEDGEAdvanced 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 requirementsTRAVEL REQUIREMENTS:Ability to drive to or travel to conferences, partner meetings, including overnight trips. Some international travel may be requiredRequires approximately 10 - 15% travelThis position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
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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.ACCOUNTABILITIES:Lead cross-functional team to ensure effective development and implementation of diagnostic strategies supporting oncology programs, including follow-on and region-specific workstreamsDrive technical assessment of assay/device analytical and clinical validationIdentify appropriate companion diagnostic partners, contribute to partnership negotiations, ensure the development of high-quality work plans and data packagesWork with external diagnostic partners to develop, file, and launch CDx / devices globally in alignment with therapeutic program development and commercial objectivesSupport BD initiatives and due diligence teamsContribute to the development of global diagnostic regulatory submissions, respond to health authority questions, and review labeling documentsFunction as a scientific and technical R&D thought leader at Takeda for diagnostic development and commercializationEDUCATION AND EXPERIENCEPhD 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 industryOncology experience requiredExperience in developing and delivering companion diagnostic work plans, assessing assay/device validation data packages, and supporting regulatory submissionsSuccessful track record leading CDx / in vitro diagnostics (IVD) development programsExperience with diagnostic submissions with international health authorities desiredExperience working with external diagnostic partners requiredPrecision medicine strategy development experienceHistopathology technical and landscape domain knowledge would be ideal, understanding of other technology platforms (PCR, genomic, immunoassays…etc) desirableExperience working with drug development teams to understand diagnostic needs and develop strategic diagnostic plans desiredSKILLSExcellent communication (written and oral) skillsExcellent strategic, interpersonal, influence, and negotiating skillsDemonstrated ability to work effectively across functions, projects, and time zones and with external partnersAbility to assemble and motivate cross functional stakeholders and drive resultsCapable of proactively predicting issues and solving problems with agilityAbility to drive decision-making within a multi-disciplinary, multi-regional, matrix teamsAbility to drive multiple priorities forward simultaneouslyKNOWLEDGEAdvanced 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 requirementsTRAVEL REQUIREMENTS:Ability to drive to or travel to conferences, partner meetings, including overnight trips. Some international travel may be requiredRequires approximately 10 - 15% travelThis position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
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