Posted to MedZilla on 11/12/2019


Takeda Pharmaceuticals

US-MA, Associate Director- Enzymology, DDI and Transporter R0010897-MZ


 
 

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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 an Associate Director- Enzymology, DDI and Transporter in our Cambrdige 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 Futureto people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As an Associate Director- Enzymology, DDI and Transporter , you will be empowered to provide enzymology and transporter strategy and plan and execute high quality in vitro and or in vivo DDI studies. A typical day will include:

OBJECTIVES:

The person is a thought leader in the enzymology and transporter related field and will provide drug discovery/development strategies to the global DMPK in support of Takeda portfolio. Expected to work closely with DMPK project representatives, Drug Discovery Units (DDUs) and Therapeutic Area Units (TAUs) and other functional areas: DSRE, QTS and Pharm Sci Groups. This person will be responsible for managing the successful delivery of project-related key performance indicators (KPI) to meet strategic objectives of projects from discovery to development and to registration for Takeda portfolio. The person will mentor, guide and supervise junior scientists within the department.

ACCOUNTABILITIES:

  • Provides enzymology and transporter strategy and leadership to support all pre-IND efforts in our Oncology and Rare Diseases Drug Discovery Units (DDUs) and all post-IND studies for all Takeda Therapeutic Area Units (TAUs), GI, CNS, Oncology and Rare Diseases.
  • Plans and executes high quality in vitro and or in vivo DDI studies to understand and quantify the biotransformation routes, enzymatic pathways (CYP, non-CYP, UGT, etc) and role of transporters involved in metabolism and disposition, and identify potential liabilities for induction and inhibition of metabolism and transport of co-administered drugs.
  • Writes comprehensive reports in support of IND/NDA submissions.
  • Provides DMPK leadership in support of clinical DDI study design and interpretation of DDI findings based on the phenotyping data, clearance pathways/mechanisms and alteration of drug-transporter activities in humans.
  • Supervises, mentors and develops multiple scientists and manage CRO activities for outsourced DDI-related work. Works closely with the scientists for their career development and progress.
  • Proactively engages with emerging technologies, participate in consortia for investigation of evolving technologies, and conduct research to improve capabilities and understanding of clearance, metabolism and transport of drugs.
  • Executes optimal outsource model to balance internal and external work load; works with solutions to achieve successful operational execution of cross-functional activities that leads to high quality asset selection and successful development.
  • Partners with DMPK project representatives and leaders with whom he/she will collaboratively guide and influence to achieve clarity on issues, bringing focus to the work plans and influencing decision-making
  • Establishes, communicates, and executes plans resulting in advancement of Takeda s portfolio by
    • Timely completion of studies while maintaining high quality standards;
    • Managing project timelines considering risk, cost, and benefit to Takeda; and
    • Working within cross-functional individuals in relevant communications, decisions and working groups as appropriate.

      EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

  • Ph.D. in Analytical Chemistry, Pharmacology and/or Pharmaceutical Sciences with a minimum of 10 years of experience in the pharmaceutical industry.
  • Hands-on laboratory experience in the evaluation of all aspects of enzymology and/or role of transporters is required.
    • Uptake and clearance mechanism of drugs
    • Reversible inhibition, TDI, induction potential of P450 enzymes, and
    • Substrate/inhibition potential of transporters. Expertise in LC/MS instrumentation and experience with
  • Other must have attributes include
    • Excellent written and oral communication skills
    • Proven track record in insightful publications contributing to of all aspects of enzymology and transporter related works.
    • Ability to work independently and having excellent written and oral communication skills.
    • Strong knowledge of clinical relevance of clearance mechanism, metabolic pathways, enzymology, drug transport across multiple organs and regulatory guidances on DDI.
    • Experience in supervising scientists and associates.
    • Ability to articulate and establish processes that have cross-functional impact and drive decision-making within a cross-functional team structure
    • Management of multiple tasks of varied complexity simultaneously
    • Excellent organizational skills
    • Highly effective presentation skills create and deliver presentations with appropriate messaging and focused recommendations
  • Ability to work in a virtual setting/across time-zones, i.e., making effective use of communication tools (WebEx, TelePresence, telephone and video conferencing, etc.) is essential
  • Additional experience, knowledge and expertise in the following areas are a plus:
    • Writing/reviewing ADME documents for regulatory submission
    • DMPK project representative in discovery and development teams.

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

    Discover more at takedajobs.com

    No Phone Calls or Recruiters Please.

    #LI-JT1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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