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DMPK Project Lead, Principal Scientist

Company: Takeda Pharmaceutical
Location: Coronado
Posted on: September 24, 2022

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 Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Project Lead DMPK in our San Diego, California office. The team is based in San Diego, CA and this role can sit either in San Diego, CA or Cambridge, MA. For individuals sitting in Cambridge, travel to the San Diego site would be expected approximately once a month and would be covered by Takeda.

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 a Lead DMPK Project Representative for a diverse range of therapeutic modalities including: small molecules, oligonucleotides, biologics and cell & gene therapies, you will be empowered to create and communicate a clear DMPK strategy and champion novel scientific approaches in support of Drug Discovery and Development for programs in the Takeda Portfolio.

  • DMPK functional leader on project teams responsible for overseeing and managing research activities within the DMPK department including assigned projects; developing and integrating the DMPK strategy to progress drug discovery programs.
  • Ensures selection and utilization of appropriate in vitro, in vivo and/or in silico methods and models to address absorption, distribution, metabolism, excretion (ADME) and pharmacokinetic (PK)-related issues across several therapeutic areas, including: GI, and Neuroscience and all therapeutic modalities, but most specifically related to oligonucleotide, biologic and cell therapies.
  • Independently designs studies, collaborates across functions, implements extensive scientific research projects and plans within DMPK, and provides leadership to the project teams. Contributes to multiple projects, acting as senior scientific subject matter expert, and may be a project team leader and/or provide key technical knowledge to a project team. ACCOUNTABILITIES
    • Establishes project direction through integrating science, key technical knowledge, and program objectives
    • Provides leadership to enable project teams to make informative decisions regarding selection and stage up of discovery compounds for pre-clinical development in GI and Neuroscience areas
    • Actively contributes to the evaluation of potential drug candidates for in-licensing
    • Contributes to the preparation/editing/review of documents for regulatory submission (i.e., study reports, IB's, IND's)
    • Independently and/or collaboratively conducts PK and PK/PD analysis during late stage lead optimization through early pre-clinical development and collaborates in PK/PD and efficacy study design to support clinical dose setting
    • Provides strategic and hands-on leadership relating to PK and ADME issues for diverse modalities including but not limited to oligonucleotide, biologics and/or cell therapies
    • Develops and mentors junior DMPK team members DIMENSIONS AND ASPECTS

      Technical/Functional (Line) Expertise
      • Demonstrates well-developed knowledge of other disciplines / departments and how they function together
      • Demonstrates exceptional project management skills and/or broad recognition for
        in-depth expertise in a scientific discipline Leadership
        • Designs and directs research strategy and activities to meet program objectives
        • Provide leadership, timelines, and contingency plans Decision-making and Autonomy
          • Independently manages workload and expectations
          • Scientifically independent
          • Scientific driver for research strategy that impacts group internally and outside area of function Interaction
            • Initiates and leads external interactions and collaborations
            • Frequent contact with internal and external personnel at various management levels
            • Collaborates with other departments and disciplines, acting as scientific authority within
              discipline
            • Serves as senior company / project representative at external conferences or business meetings Innovation
              • Determines methods on new assignments; makes strategic recommendations on projects; greater demonstrated independence; may manage junior staff EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
                • PhD degree in a scientific discipline with 6+ years experience , or
                • MS with 10+ years experience, or
                • BS with 12+ years experience
                • Deep expertise in DMPK of small molecules, oligonucleotides, biologics, or cell & gene therapies, knowledge in PK/PD/E modeling and application to clinical dose setting and predicting human efficacious dose.
                • Experience in serving on project teams in early discovery is critical. Managing the ADME and PK screening paradigm in early lead optimization, as well as early phase 1 design and human PK predictions are minimum requirements.
                • Clear track record of accomplishments (e.g. publications, patents, presentations) including evidence of leadership in managing DMPK core activities and taking one or more internally discovered compounds into preclinical and/or clinical development.
                • Recognized in the field of DMPK by both the pharmaceutical industry and the academic community.
                • Excellent oral and written communication skills and an ability to interact and conduct strategic planning with colleagues in other scientific disciplines.
                • In-depth knowledge of the overall drug discovery process and demonstrated ability to successfully direct efforts on multiple projects simultaneously.
                • Experience in PBPK modeling desired
                • Software proficiency in Phoenix and/or Watson, GastroPlus and Simcyp is desired
                • Experience in compiling and writing IND modules is desired In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

                  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. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. 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. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

                  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 Empowering Our People to Shine

                    Discover more at

                    No Phone Calls or Recruiters Please.

                    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.

                    Locations

                    San Diego, CA

                    Worker Type

                    Employee
                    Worker Sub-Type

                    Regular
                    Time Type

                    Full time

Keywords: Takeda Pharmaceutical, San Diego , DMPK Project Lead, Principal Scientist, Other , Coronado, California

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