- Provide pathology and toxicology expertise and represent DSRE on discovery, research and development project teams
- Collaborate with Global Head of Pathology and Drug Safety Therapeutic Leaders in the development and execution of strategies for discovery and development programs
- Provide stewardship, toxicology and/or pathology support and interpretation of toxicology studies on drug candidates with subsequent preparation and review of regulatory documents and support of Regulatory Affairs and Clinical groups for all phases of development, including IND through registration across all therapeutic indications
- Develop talent and mentor junior toxicologists or pathologists (Global) and the Comparative Medicine in vivo toxicology group (Cambridge site only)
- Scientific leader with deep subject-matter expertise, driving project team progression and development of technical capabilities
- Evaluate histopathology specimens from a variety of nonclinical animal species used in nonclinical toxicity studies to determine target organs and morphologic toxicity profile of potential novel pharmaceutical agents.
- Conduct peer reviews of pathology data generated off-site.
- Provide histopathology support for peripheral experimental modalities used in other departments such as immunohistochemistry and xenograft tumor models.
- Serve on project teams for drug discovery, transition and development teams
- Design and interpret toxicology studies to address human safety concerns and relevance
- Review study reports and regulatory documents for technical accuracy and regulatory adequacy
- Prepare regulatory documents (BB, IND, IB, DSUR, BLA, MAA, NDA, JNDA) and respond to health authorities concerning toxicology issues
- Collaborate and interface with project leaders across Takeda to ensure transition of programs into development
- Develop strategies for addressing toxicology issues and present them to management and governance committees
- Work with CMC to qualify impurities as needed
- Work with Comparative Medicine in vivo toxicology group on issues regarding in vivo studies and the 3Rs
- Participate in local and national toxicology/pathology meetings and represent Takeda at these meetings
- Independently manages workload and expectations Scientifically
- Independent Scientific driver for research strategy that impacts group internally and outside area of function
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- DVM and PhD degree in a scientific discipline with 10+ years experience , or MS with 14+ years experience, or BS with 16+ years experience
- Pharmaceutical drug development experience including as a project team representative (5+)
- Proficiency in histopathology
- In-depth understanding of molecular biology
- Excellent communication skills (written and oral)
- Ability and desire to take on leadership roles
- Ability to team with colleagues across different functional areas
- Proficiency with computer systems such as word processing, spreadsheets and databases
- Certification in veterinary pathology (ACVP, ECVP, or JCVP)
- Certification in toxicology (ABT or equivalent) - optional
Routine demands of an office based environment.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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
San Diego, CA