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Job DescriptionOBJECTIVES/PURPOSE
The Bioanalytical and Biomarker Sciences and Technologies (BST) department at Takeda is seeking a strong scientific leader to join the group as a biomarker development expert to support genomics-based biomarker assays/technologies to support the clinical development of novel therapeutics across a range of disease areas including cell therapies and oncology, gastrointestinal, neuroscience, and immunology.The incumbent will develop and drive genomic biomarker strategies for preclinical and clinical programs through cross-functional collaboration. The candidate may also serve as a BST Lead for programs, leading the execution of BST deliverables across a program and interfacing with cross-functional teams.The person in this role will oversee the implementation of genomics-based biomarker assays/technologies, with a focus on PCR-based technologies, including digital PCR, to support the clinical development of novel therapeutics. The candidate will support context-of-use-based biomarker development, fit-for-purpose assay validation, clinical feasibility assessments, and implementation strategies to deliver key assays and data to clinical trials to facilitate decision-making across the portfolio.The candidate will support an innovative, industry-leading genomics function responsible for establishing and piloting innovative genomics technologies, working with high-quality external genomics partners.ACCOUNTABILITIES
Develop and drive genomic biomarker strategies for preclinical and clinical programs, with a focus on cell therapies and oncology. Oversee assay development, fit-for-purpose validation/qualification, tech transfer, implementation, data delivery, and support contextual data interpretation from PCR-based assays, particularly ddPCR, alongside other genomics assays like NGS and RNASeq.Evaluate, select, and oversee high-quality external genomic labs to ensure the successful design and execution of clinical assays, including validation, longitudinal performance, and data quality.Oversee assays run under regulated approaches (GLP, GCP, GCLP, CAP/CLIA) and QC data to support primary, secondary, and exploratory clinical trial endpoints. Support clinical and translational sub-teams overseeing the end-to-end workflows from sample collection, processing, and analysis through data generation and delivery.Provide input into applicable sections of clinical documents including study protocols, regulatory documents and communications (INDs, NDAs, BLAs, PMAs, etc.), Briefing Book (BB), Investigatory Brochure (IB), Clinical Study Reports (CSR), SMP, ICF, DTA, lab manual, etc.Collaborate with translational, computational, and other scientists to design experiments leveraging genomics data and interpret data in the context of other clinical data supporting clinical drug development.Take on expanded responsibilities and special projects as they arise to support career progression.DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Deep understanding of genomics-based biomarker development with 8+ years of experience in the biotechnology or pharmaceutical environment.Extensive experience with PCR technologies, especially ddPCR, with additional expertise in other genomics technologies (NGS, RNASeq, etc.).Strong scientific background in genomics, assay development, and validation under regulated environments (GLP, GCP, GCLP, CAP/CLIA).Experience within cell therapies and oncology therapeutic areas, alongside gastrointestinal, neuroscience, and immunology.Leadership
The incumbent will Serve as a subject matter expert on BST teams, driving scientific excellence and strategic operations.Decision-making and Autonomy
Independently manage workload and expectations.Act as a scientific driver for research strategy impacting the group and beyond.Interaction
Initiate and lead external interactions and collaborations.Maintain frequent contact with internal and external personnel at various management levels.Innovation
Make strategic recommendations for relevant biomarker technologies and outputs.Complexity
Work effectively in a highly matrixed environment, navigating complex organizational structures.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
PhD in a scientific discipline with 6+ years of experience, or MS with 12+ years of experience, or BS with 14+ years of experience.Extensive drug development experience, preferably in a relevant therapeutic area.Strong scientific background in genomics technologies, biomarker development, and regulatory guidelines.Excellent communication and collaboration skills with the ability to influence and inspire within complex, matrixed environments.Enterprise mindset with strong cross-functional partnership capabilities.ADDITIONAL INFORMATION
This position is hybrid as per Takeda’s Hybrid and Remote Work policy.Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Cambridge, MAU.S. Base Salary Range:
149,100.00 - 234,300.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
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.
LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.