Project Lead, Senior Scientist, Global DMPK&M

at  Takeda Pharmaceutical

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JOB DESCRIPTION

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Senior Scientist, DMPK Project Lead in our Cambridge, Massachusetts office. As a member of Global DMPK organization, you will also have cross-site interactions.
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.

As a DMPK Project Lead for a diverse range of therapeutic modalities including: cell therapy, T-cell engager, biologics, oligonucleotides, and small molecules, 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.

• Acts as a 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: Oncology, GI, Neuroscience and all therapeutic modalities, but most specifically related to biologics, cell therapy, and oligonucleotide 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 Oncology, 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 analyses 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 T cell engagers, cell therapies, biologics and oligonucleotides
• Develops and mentors junior DMPK team members

EDUCATION, 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
• Deep expertise in DMPK of cell therapies, biologics, small molecules, or oligonucleotides, 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 through marketing 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 is highly desired
• Software proficiency in Phoenix and/or Watson, GastroPlus and Simcyp is highly desired
• Experience in compiling and writing IND modules is desired
  Location: Cambridge, MA

TAKEDA COMPENSATION AND BENEFITS SUMMARY

We 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.

Please refer the Job description for details