Principal Scientist - Pathology
Employment Type: Full-Time
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 - Pathology in our San Diego, CA 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 Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
* Takeda is looking for an experienced veterinary toxicologic pathologist to join the Global Pathology group in Drug Safety Research and Evaluation (DSRE) to serve as a representative on project teams through the provision of anatomic/clinical pathology and nonclinical toxicology expertise
* Evaluate histopathology specimens and associated data from non-GLP and GLP nonclinical toxicity studies to provide integrated interpretation of the target organs and safety profile to support novel drug candidates at all stages of development
* Collaborate with DSRE project representatives, cross-functional project teams, Global Head of Pathology and Drug Safety Therapeutic Area Leaders in the development and execution of nonclinical safety and investigative strategies for discovery and development stage programs
* Perform integrative gross and microscopic primary reads and peer reviews of animal tissues from toxicology, investigative, and discovery studies; interpret observations and determine the biologic significance of clinical pathology, organ weight, necropsy and histopathology data in the context of other study data.
* Effectively communicate pathology data and other safety data along with their implications to a broad audience in study reports, regulatory documents, and project team meetings and make recommendations for how these data impact the project team strategy and decision making.
* Serve as an integral member on project teams for drug discovery and development teams to collaborate with project leaders and R&D leadership across Takeda to ensure transition of programs into development
* Develop strategies for investigating and de-risking potential toxicology issues
* Provide scientific direction and pathology expertise to project specific IHC and ISH endpoints in collaboration with the DSRE Investigative Pathology lab
* Author and review regulatory documents (BB, IND, IB, DSUR, BLA, MAA, NDA, JNDA) for technical accuracy, regulatory adequacy and respond to health authorities concerning toxicology issues
* Participate in local and national toxicology/pathology meetings and represent Takeda in professional society committees, working groups and cross industry consortia
Technical/Functional (Line) Expertise
* Within area of accountability, may represent organization in order to influence functional and/or project team leadership and/or technical discipline.
* Provides leadership to own discipline and impacts other disciplines.
* Solves unique and complex problems with broad impact on the business.
* Works independently to navigate complex situations and serve as the primary resource on complex issues in the discipline.
* Requires conceptual and innovative thinking to develop new creative solutions
* Leads and/or provides direction to cross-functional projects with significant complexity.
* Decisions have an extended impact on discipline's work processes and outcomes.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
* DVM and MS (required)/PhD (preferred)
* Proficiency in toxicologic pathology (3-5 years of experience)
* Pharmaceutical drug development experience including as a project team representative (preferred but not required)
* Experience with alternative modalities (gene therapy, cell therapy, oligonucleotides)
* 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, databases, Halo, Pristima (or other pathology data capture systems)
* Certification in veterinary pathology (ACVP, ECVP, or JCVP)
* Certification in toxicology (ABT or equivalent) - optional
* Willingness to travel to peer review, various internal and external meetings, including overnight trips. Some international travel may be required. Requires approximately ≤ 5% travel.
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.
San Diego, CA