Posted to MedZilla on 10/18/2018


Takeda Pharmaceuticals

US-CA, Principal Scientist - Modeling & Simulation - San Diego, CA R0004489-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Principal Scientist, Modeling and Simulation, in our San Diego, California office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Principal Scientist, Modeling and Simulation, working on the DMPK team, you will be empowered to provide and execute modeling and simulation strategies for projects in the Takeda, California portfolio.

OBJECTIVE:

  • A Modeling and Simulation expert will lead and be responsible for model-based decision support for the TCAL portfolio in the translational (PKPD and Systems Pharmacology), and nonclinical development (biopharmaceutics/ ADME/tox) spaces within DMPK.
  • Modeling support provided by this function will enable faster and more accurate decision-making in preclinical discovery and development, as well as for clinical drug development choices for first-in-human or Phase I trials.
  • The role involves both practical application of Modeling and Simulation techniques to expedite drug discovery and development, and bridging discovery level understanding of exposure-response to the clinical translational team(TREC). The group relies on close working relationships within the company, as well as strong tie-ins with external collaborators and key opinion leaders. A critical aspect of this role is the expansion of the group s influence and intellectual leadership across other sites within the Takeda global organization.

ACCOUNTABILITIES:

  • Manage routine support for quantitative pharmacology for all projects within the TCAL pipeline, ensuring impact and key deliverables for external regulatory (e.g. IND, IB) and internal decision-making documents.
  • Operationalize and contribute to the vision and strategy for the Modeling and Simulation group.
  • Provide and execute modeling and simulation strategy for projects in the TCAL portfolio.
  • Propose and build consensus for standardized approaches for quantitative pharmacology.
  • Develop standardized procedures and record-keeping approaches that support engagement in areas that may potentially be audited as part of an FDA visit.
  • Identify and champion novel scientific approaches to develop innovative applications of modeling and simulation to biology, pharmacology and nonclinical sciences (ADME, toxicology).
  • Engage with key stakeholders, and build strong collaborative relationships.
  • Identify novel areas for engagement for the group and develop new capabilities with new customer departments.
  • Train and develop scientists to function effectively as independent modelers, strong at both the technical and influence aspects of the role.
  • Build a culture that encourages close collaboration, free sharing of ideas, and calculated risk-taking.
  • Coordinate efforts closely with key stakeholders (such as the DDU heads, Clinical Pharmacology, Experimental and Translational Medicine and toxicology) and work closely with the DMPK site head to set priorities and assign resources.
  • Build win-win partnerships with other functions operating in the mathematical/simulation space (such as Biostatistics, Translational Modeling and Pharmacometrics).
  • Provide leadership within industry and academic scientific bodies through key presentations, external posters and publications, thereby building the scientific reputation of the TCAL Modeling and Simulation group as an industry leader in the field.
  • Act as the global modeling and simulation expert internally at Takeda

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Required:

  • Ph.D. in the life sciences (e.g. biology, biochemistry, biophysics or pharmacology), chemical engineering, pharmacokinetics, or related disciplines.
  • A minimum of 8 years relevant experience in PKPD/mathematical modeling.
  • Demonstrated expertise in modeling (PK/PD, systems biology or mathematics).
  • Fluency with standard modeling software (e.g. Mathematica, MATLAB, WinNonlin Phoenix or NONMEM).
  • Demonstrated ability to manage projects and stakeholders.
  • Entrepreneurial spirit- drive and initiative.
  • Flexibility and scientific curiosity.
  • Strong influence and leadership skills.
  • Excellent interpersonal and communication skills.
  • A proven track record of direct or in-direct supervision of Ph.D. and non-Ph.D. level scientists.
  • A strong track record of publications and posters.
  • A clear conceptual understanding of drug discovery and development.
  • Strong mentoring and coaching skills as a manager.

Strong plus:

  • Expertise in statistical analyses (e.g. model building, fitting, machine learning, regression analysis).
  • Hands-on experience in in vivo or in vitro pharmacology, biomarkers (pre-clinical or clinical) or drug metabolism/ pharmacokinetics.
  • Broad expertise in various aspects of drug discovery and development, ideally in more than one functional area.
  • In-depth knowledge of biology and a deep understanding of in vivo experimental model systems used in drug discovery and development.
  • Experience as a project representative in discovery or development, in a preclinical (biology/pharmacology), nonclinical (DMPK/toxicology) or translational setting.
  • Proven track record in one or more of the following: negotiation, mediation, conflict resolution or change management.

LICENSES/CERTIFICATIONS:

  • Training/coursework in PK/PD modeling is a plus.

TRAVEL REQUIREMENTS:

  • The position is located in our San Diego, California office and may require travel <10%

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

Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

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