Senior Scientist, Bioanalytical and Biomarker Sciences & Technologies

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Join us as Senior Scientist, Bioanalytical and Biomarker Sciences & Technologies in our Cambridge, Massachusetts office.OBJECTIVES/PURPOSEUnder minimal supervision, responsible for executing bioanalytical assay method development, transfer, and validation at qualified vendors.  Incumbent is also responsible for coordination of sample analyses at bioanalytical vendors, monitoring bioanalytical vendors to ensure quality, assay results, and bioanalytical reports.  Responsibilities also include support for LC/MS/MS-based biomarker assays.Incumbent must demonstrate a sustained record of scientific productivity in the field of bioanalytical chemistry, as evidenced by the development and/or implementation of numerous new technical strategies, methods, processes, publications, or patents.May manage a dedicated staff of Bioanalytical Chemistry scientists who are responsible for executing bioanalytical assay method development, transfer, and validation at qualified vendors, as well as coordination of sample analyses at bioanalytical vendors, monitoring bioanalytical vendors to ensure quality, assay results, and bioanalytical reports.Interacts closely with colleagues within Quantitative Clinical Pharmacology, Translational Science and allied functions, including Clinical Operations and Analytical Sciences, to effectively manage the bioanalytical chemistry support of clinical Ph 0-4 studies and related issues.  Will also effectively interface with DMPK colleagues to ensure global collaboration on bioanalytical chemistry activities to support clinical development.How you will contribute:ACCOUNTABILITIESProvides expert scientific opinion, input, and oversight for bioanalytical chemistry activities for 3 or more global development programs, including vendor selection, assay development or transfer, validation, sample analysis and reporting.Provides the strategic leadership and direction necessary to ensure the scientific integrity and quality of all bioanalytical chemistry data, as well as the appropriate interpretation of experimental results and adequacy of final reports.May lead a group of Bioanalytical Chemistry scientists within B2ST, under the general supervision of the Director or Sr Director of Clinical Mass Spectrometry, providing guidance and scientific oversight for that group.Forges strong alliances with strategic partners to incorporate cutting-edge scientific approaches for development compound and biomarker bioanalytical support across the portfolio.Reviews or prepares bioanalytical chemistry portions of regulatory documents: Investigational New Drug (IND) Applications, Briefing Documents, Investigational Brochures, Investigational Medicinal Product Dossiers (IMPD), Common Technical Documents as the basis for New Drug Applications (NDA), Biologic Licensing Application (BLA) and Marketing Authorization Applications (MAA), IND annual reports, other EMEA/CHMP regulatory documents, and scientific white papers.May represent Takeda in written, oral, and face-to-face interactions with global regulatory agencies, particularly in area of personal expertise in bioanalytical chemistry.Represent Takeda at external meetings and conferences as well as establish the reputation of Takeda with key opinion leaders, practitioners, partners and agents, and the public at large. Supports publication and presentation of bioanalytical data in support of Takeda compounds.Collaboratively interact with scientists from other functional areas in PTS, as well as from other Takeda divisions, affiliates, and alliance partners.May supervise Scientist I/II, Research Senior Scientists or interns.DIMENSIONS AND ASPECTS Technical/Functional (Line) ExpertiseDeep understanding of mass spectrometry-based PK and biomarker development and implementation with 10+ years' experience in the biotechnology or pharmaceutical environment.Strong scientific background and experience with global Regulated assay development and validation across technology platforms in sample preparation methods as well as mass spectrometry platformsExperience with outsourcing and working with external partners to develop/transfer assays, oversee data generation/analysis and delivery of high-quality data from global clinical trials under regulated settings (GLP, GCP, GCLP and CAP/CLIA etc.).Experience within GI, immunology, neurology and/or oncology therapeutic areas, and experience supporting novel modalities.LeadershipThe incumbent will serve as a subject matter expert on BST teams helping drive scientific excellence, strategic, tactical and fiscally responsible operations in support of BST and programmatic goals.Decision-making and AutonomyUnder minimal supervision, manages workload and expectationsUnder minimal supervision operates with scientific independenceScientific driver for research strategy that impacts group internally and outside area of functionInteractionInitiates and leads external interactions and collaborationsFrequent contact with internal and external personnel at various management levelsInnovationMakes strategic recommendations for relevant novel PK and biomarker technologies and outputs in alignment with stakeholders.Minimum Requirements/Qualifications:EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:PhD degree in a relevant scientific discipline e.g., Chemistry, Analytical Chemistry, Clinical Chemistry, Biochemistry, etc. with 5+ years experience,  MS with 10+ years experience, or BS with 12+ years experience; 5 years of Industry experience requiriedSignificant drug development experience from a bioanalytical chemistry perspectiveIn depth, expert knowledge of bioanalytical chemistry, including sample preparation procedures, HPLC and mass spectrometry (MS/MS) analysis techniques and instrumentation, and validation experimental design and related laboratory statistics. Experience with ligand binding assay and immunoaffinity approaches are a plus.Superior analytical and problem-solving skills.Excellent oral and written communication skills, including writing, reviewing, and editing scientific documents.Demonstrated capabilities to lead and mentor other scientists.Previous experience managing bioanalytical chemistry projects, personnel and bioanalytical vendor management.Ability to lead and participate in a matrix team environment.Strong knowledge of allied fields critical for drug development, such as clinical pharmacology, drug metabolism, pharmacology, toxicology, and pharmaceutical science.Thorough understanding of drug development and global regulatory requirements.Ability to effectively influence colleagues and multi-disciplinary project teams.ADDITIONAL INFORMATIONNo specific license or certification requiredRoutine demands of an office based environmentSome domestic and international travel to Takeda sites, bioanalytical vendors, conferences, and regulatory agencies may be required. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.Takeda Compensation and Benefits SummaryWe 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:Boston, MAU.S. Base Salary Range:$133,000.00 - $209,000.00The 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 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 timeSummaryLocation: Boston, MAType: Full time