Associate Scientific Director / Principal Scientist Bioanalytical Sciences-Biologics, CBID

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 DescriptionAssociate Scientific Director / Principal Scientist Bioanalytical Sciences-Biologics, CBID Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Associate Scientific Director / Principal Scientist Bioanalytical Sciences-Biologics, CBID in 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 deliver Better Health and a Brighter Future to people around the world.Here, you will be a vital contributor to our inspiring, bold mission.As Associate Scientific Director / Principal Scientist Bioanalytical Sciences-Biologics, CBID working on the Clinical Biomarker Innovation and Development team, you will be empowered to drive its pharmacokinetics and immunogenicity strategy design and implementation that will impact clinical development paradigms and bring value to patients.- A typical day will include:POSITION OBJECTIVES:

• The Clinical Biomarker Innovation & Development department at Takeda is seeking a strong scientific and strategic leader to join its Bioanalytical Sciences (BAS)-Biologics group and drive its pharmacokinetics and immunogenicity strategy design and implementation that will impact clinical development paradigms and bring value to patients. Manage projects in different therapeutic modalities across Neuroscience, Gastroenterology, Immuno-oncology, and Rare Diseases.
• Partner in developing a strong and compelling vision for the Bioanalytical Sciences organization, which ensures meeting critical needs of the company, and its development and commercial pipeline. With an increase in the therapeutic areas, complexity, diversity and number of molecules/modalities in our portfolio,
• Provide technical, drug development and regulatory expertise in all aspects of bioanalytical sciences-with emphasize on pharmacokinetics and immunogenicity on different therapeutic modalities including antibodies, ADC, recombinant human proteins/enzymes, multidomain fusion proteins, cell & gene therapies.
• Develop and leverage cutting-edge technologies that can significantly impact clinical drug development decisions and bring value to patients and prescribers.
• Establish their own laboratory, train post-docs, junior scientists and interns.POSITION ACCOUNTABILITIES:
  • SME for immunogenicity assessment, risk mitigation strategies, developing collaborations with health authorities to understand these issues.
  • Represent BAS and CBID at internal scientific reviews and governance. meetings, external forums and consortia and any health authority interactions.
  • Drive, develop and oversee execution of bioanalytical strategy and plans within the BAS group and Takeda designated CROs. Accountable for group's delivery of clinical bioanalytical results and reports, and regulatory requirements for assay development, validation and clinical studies.
  • Provide bioanalytical scientific leadership to enable and drive robust and timely-decision making through all stages of clinical development at program team meetings and during regulatory interactions.
  • Build relationships & collaborate with scientific leaders, KOLs, academic partners, CROs, and health authorities
  • Lead scientific due diligence to assess cutting-edge technologies and establish external partnerships as needed.
  • Oversee plans for technical on-site visits of external laboratories responsible for testing clinical bioanalytical samples.
  • Coach and guide staff on scientific concepts and technical details of various bioanalytical methodologies. Play a major role in developing and maintaining a culture that is innovative, encourages risk, and supports the development of its peopleEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
    • A PhD or MD/PhD in pharmacology, immunology or related discipline with at least 10 year experiences in the industry
    • A track record of sustained, significant scientific contributions as demonstrated by publications, patents and presentations
    • Extensive drug development experience preferably advancing several molecules from phase I-4 and supporting post-marketing/commercial activities.
    • Strong scientific background and experience with clinical bioanalytical assay development and validation. Subject matter expert in PK and immunogenicity assay strategy design and implements, experiences in cell and gene therapy is plus.
    • Capable of applying the highest scientific and technical standards for the successful design and execution of clinical bioanalytical assays implemented from early to late-stage clinical programs.
    • Strong communication skills; ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments.
    • Broad and strong network in the industry, biotech, and health authoritiesTakeda U.S. Vaccine Requirement:Absent 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. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles.- 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. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.This job posting exclude Colorado applicants.TRAVEL REQUIREMENTS:
      • Some domestic and international travel to Takeda sites, bioanalysis vendors, and regulatory agencies may be required.-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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.*RM-LIEEO 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 , Associate Scientific Director / Principal Scientist Bioanalytical Sciences-Biologics, CBID, Executive , Rochester, New York