Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director/Director, Clinical Biomarker Innovation and Development, in our QTS group at our Cambridge, MA 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 deliverBetter Health and a Brighter Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- The genomics Scientist is an acknowledged subject matter expert in genomic biomarker assay and patient characterization platforms whose primary role is to direct the design and implementation of clinical biomarker plans supporting the clinical biomarker strategy for core therapeutic area programs: Oncology, Rare Diseases, Gastrointestinal and Neuroscience.
- Primary responsibility is to direct a group of bioassay scientists in the translation of preclinical assays into clinical use, design and management of genomic assay validations at a vendor lab, supporting clinical study start-up activities including protocol writing and monitoring the performance of the clinical assay during clinical study conduct.
- The genomics group will partner with DDU scientists and clinical project teams to identify biomarkers relevant to clinical application, providing scientific and strategic expertise to generate clinical biomarker plans including technical feasibility, clinical context of use and regulatory requirements. The goal is to deliver high-quality clinical biomarker data to advance clinical programs to key decision points.
- The genomics Scientist must remain current and lead scientific due diligence to assess cutting-edge technologies and establish external partnerships to drive platform innovation.
- This position will contribute to strategic thinking on CBID leadership team.
- Direct operational and scientific activities of a group of genomics scientists.
- Member of CBID leadership team
- Contribute to CBID strategy and future planning for the organization.
- Provide strategic, technical and scientific leadership for development, implementation and data interpretation of an integrated clinical biomarker plan supporting proof of concept, decision making and registration for assigned clinical programs across therapeutic areas.
- Work with multiple Takeda functions to ensure biomarker assay needs for clinical development strategy are defined and technically delivered within the required clinical study timelines.
- Work with DDU Translational scientists and DMPK scientists to translate preclinical biomarkers assay associated with mechanism of action and drug response into clinically useful assays.
- Responsible for the preparation and review of biomarker sections of candidate nomination documents, clinical protocols and documents submitted to Regulatory Agencies.
- Subject matter expert in several technical platforms such as immunohistochemistry (IHC), immunofluorescence (IF), multiplex IF, flow cytometry, NGS.
- Ability to independently QA/QC and analyse data from assay results
- Given that clinical biomarkers are completely externalized to vendor labs, manage the vendor labs to ensure timely delivery of high quality clinical data meeting clinical laboratory standards and regulatory requirements
- Conduct technical on-site audits of vendor labs responsible for testing clinical biomarker samples.
- Responsible for identification and assessment of innovative new technology platforms for clinical use
- Will supervise direct reports as leader of bioassay platform team
- Participate in external scientific organizations, symposia and consortia representing Takeda biomarker line function
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Minimum MS/PhD with 10+ years of pharmaceutical experience in biomarker assay design, development and clinical implementation
- Subject matter expert with extensive technical experience in genomics-based biomarker and patient characterization technologies required.
- Biological knowledge in a relevant scientific area, e.g., Oncology, Immunology, Neuroscience, Gastrointestinal, Biochemistry, Molecular Biology, Cell Biology required.
- Previous managerial experience required
- Pharmaceutical industry experience in translational and biomarker assay development required.
- Hands-on experience to manage outsourcing of assays to external CROs
- Capable of applying the highest scientific and technical standards for the successful design and execution of clinical biomarker assays implemented in early and late stage clinical programs.
- Superior analytical and problem-solving skills.
- Good communications skills, both oral and written.
- Exceptional organizational, interpersonal and time management skills.
- Experience working within a team-centric dynamic in an independent manner
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
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