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Oncology Clinical Biomarker Lead

Company: Takeda Pharmaceutical
Location: Rochester
Posted on: November 19, 2021

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 and . 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.OBJECTIVES:- Takeda is committed to outsmarting cancer so that more patients may have access to our transformational medicines - a robust precision and translational medicine approach in drug development is of critical importance to achieve this important objective.- The Oncology Clinical Biomarker Lead (CBL) role is an exciting new opportunity within the growing Precision & Translational Medicine (PTM) function in the Oncology Therapeutic Area Unit (OTAU) at Takeda.- CBLs are scientific leaders that develop and oversee clinical biomarker strategy for a program.The CBL is the primary scientific leader and driver of the clinical biomarker strategy at the clinical study level. This role will partner closely with key leaders and functions across Takeda Oncology R&D including Global Translational Leads, Clinical Science, Clinical Operations, Drug Discovery, Clinical Pharmacology, Companion Diagnostics, Computational Biology, Data Science Institute (statistics, real world evidence, quantitative systems pharmacology), Translational Program Management, Data Strategy, clinical biomarker technologies, and Discovery to develop and deliver the program and study level clinical biomarker strategy for early and/or late clinical stage oncology development programs. -This role also leads the analysis, interpretation and reporting of clinical biomarker data, and develops predictive, pharmacodynamic and response hypotheses to evaluate in clinical studies. -This position is to support our exciting TAK-573 (anti-CD38/attenuated interferon alpha fusion protein) program in multiple myeloma.The level of the position will be determined based on the skills and experience of the candidate.ACCOUNTABILITIES:-

  • Develops and delivers the study level clinical biomarker strategy
  • Develops and integrates innovative robust, testable clinical biomarker hypotheses including those for patient selection, target engagement, pharmacodynamics, mechanism of action into clinical studies
  • Analyzes, interprets, reports, and communicates clinical biomarker data to inform program decisions, publications, evidence generation
  • Contributes to the program level translational strategy, identifies and leads external translational/biomarker collaborations as needed
  • Primary translational contributor (authors sections) into clinical study protocols, case report forms, informed consent templates, clinical study reports
  • Leads and participates in oncology disease area research
  • Identifies translational issues and resources needs, develops solutions, and escalates to the Global Program Team, Clinical Sub Team, Translational Research Sub Teams and leadership of Precision & Translational Medicine, as needed
  • Partners with Medical Affairs to develop and integrate translational data into program level publication, and investigator sponsored research strategies
  • Partners with the companion diagnostic R&D, regulatory and commercial teams to prioritize biomarkers for diagnostic development and ensures seamless transition to diagnostic development and commercialization as needed
  • Partners with Regulatory Affairs, Clinical Science to incorporate translational elements with rigor into BLA and NDA filings with health authorities, works closely with the program team to respond to health authority questions or requests for information; may participate in health authority meetings as needed
  • Summarizes data into scientific abstracts, presents data at conferences, publishes data in peer reviewed journalsEDUCATION AND EXPERIENCE
    • PhD, MS, or BS in immunology, immuno-oncology, cancer biology, genetics, pathology, or related scientific field with 8+ years (PhD) years of post degree experience in pharmaceutical or biotech R&D
    • Strong scientific track record in contributing to drug development program advancement required
    • Oncology experience desired
    • Experience developing and delivering clinical biomarker strategies for clinical stage programs where work is outsourced to external vendors desired
    • Experience developing and testing translational hypotheses, interpreting translational data in clinical studies desired
    • Experience analyzing and interpret data from Oncology clinical trials, including understanding pharmacodynamic data, identifying patient subpopulations with increased clinical response, drawing conclusions, and inform new experiments or clinical studies desiredSKILLS
      • Strong drive for results and to make a difference
      • Scientific rigor and curiosity
      • Demonstrated ability to work and collaborate effectively in a highly matrixed environment across functions, projects, and time zones to drive results according to tight timelines, a strong team player
      • Strong scientific leader, able to design fit-for-purpose, prioritized clinical biomarker strategies for Oncology Development programs, analyze and interpret data
      • Experience designing and interpreting multiplex pathology assay and RNA expression data
      • Ability to lead working groups and scientific sub-teams as needed
      • Ability to build testable hypotheses for clinical trials using internal and external data sources
      • Experience generating high quality publications in peer reviewed journals
      • Experience integrating biomarker strategies into clinical trials - providing input in clinical protocols, case report forms, informed consent forms, clinical study reports
      • Ability to communicate effectively to study investigators to explain clinical biomarker rationale, seek feedback on clinical biomarker plans and/or data
      • Identify and oversee translational research collaborations as needed
      • Excellent communication (written and oral) skills
      • Ability to proactively identify issues and solve problems with agility
      • Ability to drive multiple priorities forward simultaneouslyTRAVEL REQUIREMENTS:
        • Ability to travel to scientific conferences, investigator meetings, including overnight trips as needed
        • Requires approximately 5% travelWHAT 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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.In 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

Keywords: Takeda Pharmaceutical, Rochester , Oncology Clinical Biomarker Lead, Healthcare , Rochester, New York

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