Associate Director- DMPK
Location:
Cambridge , Massachusetts
Posted:
October 23, 2017
Reference:
1701819


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 an Associate Scientific Fellow/DMPK Lead in our R&D world headquarters in Cambridge , Mass .

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Scientific Fellow leading the DMPK team, you will be empowered to head our cutting edge, future focused science of large molecule and protein development teams and provide DMPK expertise.

POSITION OBJECTIVES:

This position will lead large molecule and protein drug development project teams at the early stage of R&D, providing DMPK expertise, strategy and leadership across Takeda’s robust product pipeline. Additional attributes include collaborating across sites and with CROs to conduct nonclinical DMPK studies, working diligently cross-functionally in an integrated way to resolve project issues, and supporting regulatory filings.

POSITION ACCOUNTABILITIES:
  • Provide leadership on DMPK activities at various team levels
  • Responsible for the planning, designing, and managing of DMPK and TK studies internally or at CROs
  • Identify potential risks and provide mitigation strategies. Working with teams to resolve project issues
  • Collaborate closely with Nonclinical and Clinical Pharmacology, CMC, Radiochemistry, Toxicology, and other functions to move projects in an efficient manner
  • Support Quantitative Clin Pharm with pharmacology and ADME studies
  • Write DMPK sections of regulatory filings at various stages of drug development, and response to regulatory queries


Qualifications:


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
  • PhD in Pharmacokinetics or related discipline.
  • A minimum of 8 years of direct DMPK experience in Pharmaceutical/Biotech industry supporting project teams is required
  • Thorough knowledge of pharmacokinetics, metabolism, drug interactions, and regulatory requirements
  • Experience with protein therapeutics development
  • Track record of innovative science in solving DMPK issues
  • Demonstrated quality of working collaboratively and effectively with interdisciplinary research and development teams
  • Experience with PK/PD, SimCyp modeling
  • Strong motivation and the ability to work independently
  • Excellent verbal and written communication skills.

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

No Phone Calls or Recruiters Please.

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A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.

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