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Position:
Principal Scientist, DMPK Project Representative, Oligos, Cell Therapy, Biologics

Employer:
Takeda

Description:

As a Principal Scientist DMPK Project Representative working on the Global DMPK team, 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 which include assigned projects and developing and integrating the DMPK strategy to progress drug discovery programs.
  • Ensures selection and utilization of appropriate in vitro, in vivo, 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 CNS and across 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 or provide key technical knowledge to a project team.
  • Develops and mentors junior DMPK team members.

 

 

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
  • Plays an active role in 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

 

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


Qualifications/Experience:
  • PhD degree in a scientific discipline with 8+ years experience , or
  • MS with 12+ years experience, or
  • BS with 14+ years experience
  • Deep expertise in DMPK of both oligonucleotide and biologics, 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 PK and PBPK modeling desired
  • Software proficiency in Phoenix and/or Watson, GastroPlus is desired
  • Experience in compiling and writing IND modules is desired


Location: San Diego

Contact: https://www.takedajobs.com (Job ID: R0040856)

Post Date: 8/19/2021 12:00:00 AM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 10/18/2021; Admin Logon
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