Posted to MedZilla on 8/20/2019


Takeda Pharmaceuticals

US-CA, Principal Scientist - Toxicology R0010385-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 a Principal Scientist - Toxicology at our recently dedicated San Diego Research Site.

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.

Here, you will be a vital contributor to our inspiring, bold mission. As a Principal Scientist - Toxicology, you will be empowered to serve on project teams for discovery to development programs.

OBJECTIVES:

This position is for a Toxicologist in the global Drug Safety Research and Evaluation group (DSRE) at Takeda California, Inc., located in San Diego, CA. The candidate will serve as a project team representative responsible for design, interpretation, reporting, and presentation of nonclinical safety studies/programs. This position will primarily support Gastrointestinal (GI) and Neuroscience (NS) disease areas. As a member of project teams, the candidate will interact and provide guidance to other functional areas (e.g., DMPK, Medicinal and Process Chemistry, Regulatory Affairs, Pharmacovigilance, and Clinical groups) regarding the necessary types of studies and the impact of findings from nonclinical safety studies on project progression. The candidate must be scientifically independent, and will be responsible for presentations to internal committees and at external meetings as well as collaborating with scientists across our global sites in Boston and Japan and on collaborative programs with partner companies.

ACCOUNTABILITIES:

  • Will serve as a DSRE representative on matrixed project teams for development programs, primarily for GI and NS therapy areas, but with the possibility of supporting oncology and rare disease therapy areas as the need arises
  • Will serve as, or work with a study monitor to oversee the design, interpretation and reporting of exploratory and GLP-compliant studies that are outsourced
  • Must be able to effectively contextualize study plans/results for team decision making in support of asset characterization
  • Ensures that assigned projects are progressed within project timelines and budgetary agreements
  • Independently provides well-written reports and regulatory documents; communicates directly with internal review boards and externally, including global regulatory agencies
  • Collaborates with other departments, and disciplines, acting as scientific authority within discipline to coordinate interdepartmental activities for successful completion of safety studies
  • Provides safety expertise regarding in- and out-licensing of company assets and helps develop a strategy to mitigate potential safety liabilities
  • Serves as a senior company/project representative at external scientific or business meetings

MINIMUM EDUCATION/EXPERIENCE:

  • PhD degree in a scientific discipline with 8+ years experience, or Master's degree in a scientific discipline, or equivalent with 13+ years experience, or Bachelor's degree in a scientific discipline, or equivalent with 16+ years experience
  • Experience as a nonclinical safety representative on project teams
  • Exceptional knowledge of GLP Regulations
  • Experience in working with contract research organizations
  • Experience in dealing with global regulatory agencies
  • Candidate must be adaptable to a dynamic work flow and must be highly collaborative

LICENSES/CERTIFICATIONS:

Board certification in toxicology desired, but not required

TRAVEL REQUIREMENTS:

Ability/willingness to travel to meetings or client sites (domestic and international; approximately 5 10%)

LOCATION:

San Diego, CA

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.

No Phone Calls or Recruiters Please.

#LI-KL

Locations

San Diego, CA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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