Head of Oncology Cell Therapy Clinical Immunogenicity

Company: Takeda Pharmaceutical
Location: Malden
Posted on: May 19, 2023

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda''s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?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.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.OBJECTIVESTakeda is committed to outsmarting cancer so that more patients may have access to our transformational medicines - a robust precision and translational medicine approach thoughtfully and strategically applied in drug development is of essential importance to achieve this important objective of our Oncology drug development organization. Takeda is seeking a strong scientific and strategic leader to build and lead our Oncology Cell Therapy Clinical Immunogenicity function. This is an exciting new role within the growing Precision & Translational Medicine (PTM) function in the Oncology Therapeutic Area Unit (OTAU) reporting into the Head of Clinical Biomarker Sciences and Operations. This individual will serve as the PTM resident immunogenicity expert, whose role includes advising clinical teams on the best practices for implementing cell therapy immunogenicity assays into oncology Phase 1-3 clinical trials. They will identify high quality regulated vendors, transfer assays for validation and oversee sample analysis supporting primary, secondary and exploratory clinical trial endpoints.AccountabilitiesThe Head of Oncology Cell Therapy Clinical ImmunogenicityBuild and lead a high-performing, immunogenicity team responsible for overseeing assay development, qualification, validation, technology transfer and data interpretation from immunogenicity assays.Oversee sample analysis from oncology cell therapy programs run under regulated approaches (GLP, GCP, GCLP, CAP/CLIA).Work closely with outsourcing team to ensure high quality and timely delivery for the method setup and sample analysis.Review, interpret and approve immunogenicity reports and related components in regulatory submissions (INDs, NDAs, BLAs, PMAs etc.). Contribute to the preparation of the integrated summary of immunogenicity (ISI), regulatory responses and submissions.Evaluate, select, and oversee external labs to ensure successful design and execution of clinical assays, including feasibility, validation, longitudinal performance and data quality. Collaborate with translational scientists to design experiments that leverage immunogenicity data to support oncology cell therapy clinical development.Serve at the subject matter expert on immunoassay platforms. Review DTS and DTA agreements.Recruit, mentor, develop and retain talent.Education And ExperienceA PhD or MS in Biochemistry, Immunology, cell biology or related discipline with at least 8 years of relevant regulated immunogenicity experience beyond post-doctoral training, including at least 2 years of industry experience supporting clinical development.Strong scientific background and experience with immunoassay development and validation across multiple immunoassay platforms (e.g., EIA, MSD, Luminex and Gyros, etc.). Deep knowledge of regulated clinical immunogenicity assay, whitepapers and regulatory guidelines.Experience with outsourcing and working with external CRO partners to develop/transfer assays, oversee sample analysis, data generation and delivery of high-quality data from global clinical trials under regulated settings (GLP, GCP, GCLP and CAP/CLIA etc.).Familiarity with clinical documents and processes, such as clinical protocols, informed consent forms, laboratory manuals, sample management forms, data transfer agreements, etc.Experience identifying, evaluating and establishing regulated immunoassay vendors to support global clinical trials in countries including Japan, China, Brazil, and European countries.Experience in establishing immunoassay laboratories.Prior management experience required including recruiting, coaching and developing key talent.Strong written and oral communication skillsTravel RequirementsAbility to drive to or travel to conferences, partner meetings, laboratory audits as needed, including overnight trips. Some international travel may be requiredRequires approximately 5 - 15% travelWHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution PlanTuition reimbursement Company match of charitable contributionsHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach ProgramsAbsent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.LI-JT1EEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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