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Project Representative, DMPK

Company: Takeda Pharmaceutical
Location: Encinitas
Posted on: May 11, 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 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? Join us as Project Representative DMPK in our San Diego, California 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.OBJECTIVES

  • As part of the Global DMPK team represent DMPK on multidisciplinary therapeutic project teams developing and integrating the DMPK strategy to progress drug discovery programs.
  • Collaborates within DMPK to align on appropriate screening cascades with multi-parametric optimization and translational PKPD approaches enabling project progression.
    • Contribute to functional problem resolution and objective setting to address PK, ADME, and PK/PD-related questions for Gastrointestinal and Neuroscience therapeutic projects.ACCOUNTABILITIES - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
      • Represent DMPK in multifunctional discovery Gastrointestinal and Neuroscience project teams collaborating with pharmacology, toxicology, chemistry and key stakeholders in discovery project teams to ensure stategic alignment
      • Develops and oversees novel scientific projects and will manage the work of others directly or in a matrixed structure implementing best practices relating to DMPK (including in vivo PK and in vitro ADME), to address absorption, metabolism and pharmacokinetic issues
      • Independently develops solutions and strategies within ADME sciences while using breadth of knowledge of other disciplines to enable decision making for the advancement of therapeutic projects
      • Participates in early clinical candidate selection and asset characterization for various therapeutic modalities (Small molecules, Biologics, Oligotherapies, Cell Therapies) in support of clinical trials
      • Ensures the appropriate conduct of studies, leads the interpretation of study results, and prepares study reports suitable for internal or regulatory use
      • Scientifically assesses and recommends vendors, and outsources nonclinical studies to appropriate contract research organizations
      • Conducts human PK predictions with high level instructions and contribute to human efficacious dose selection and safety margin of exposure evaluation.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 forin-depth expertise in a scientific disciplineLeadership
          • 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 withindiscipline
              • Serves as senior company / project representative at external conferences or business meetingsInnovation
                • Determines methods on new assignments; makes strategic recommendations on projects; greater demonstrated independence; may manage junior staffEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: -
                  • PhD degree in a scientific discipline with 3+ years experience , or
                  • MS with 9+ years experience, or
                  • BS with 11+ years experience
                  • Demonstrated experience in conducting PBPK modeling is preferred
                  • Experience in PK/PD analysis and mathematic modeling is preferred
                  • Proficiency in modeling software such as Phoenix, NONMEM, MatLab, SAAM II, GastroPlus or Simcyp
                  • Demonstrated ability to apply ADME and PK screening paradigm in early lead optimization are minimum requirements
                  • Excellent oral and written communication skills and an ability to interact and conduct strategic planning with colleagues in other scientific disciplines.
                  • Experience in compiling and writing IND modules is desiredThis job posting excludes CO applicantsAbsent 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 ProgramsEmpowering Our People to ShineDiscover more at takedajobs.comNo Phone Calls or Recruiters Please.#LI-KL1EEO 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.LocationsSan Diego, CAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Encinitas , Project Representative, DMPK, Other , Encinitas, California

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