Associate Principal Scientist, Toxicology​/Study Director

Job Description

The Nonclinical Drug Safety department is seeking a - motivated and talented - toxicologist - to conduct and/or monitor toxicity studies (GLP and non-GLP) as a Study Director or Study Monitor. Toxicologists at our Company are integral members and leaders of collaborative cross functional scientific teams, addressing challenges from early discovery to late development. Our toxicologists provide scientific leadership in the design and overall conduct
-of in - vivo studies and integrate the findings from all contributing scientists into reports that characterize the safety profile of drug candidates.

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• Serve as the single point of control (Study Director) on assigned acute through chronic general toxicology studies across all - modalities.
• Interact - with technical, veterinary, and scientific staff to ensure that the study - is in compliance with - the protocol, amendments, Standard Operating Procedures, regulations, safety guidelines, and company policies and procedures.
• Critically analyze and interpret data. Integrate data from other areas (e.g., clinical pathology, pathology, - toxicokinetics ) in written reports used for regulatory - submissions, and - communicate results within established timelines.
• E nsure regulatory rigor, proactive risk identification, and timely study execution .
• Demonstrate enterprise mindset and strategic thinking, proactively identifying opportunities, anticipating challenges, and contributing to solutions aligned with
  - Nonclinical Drug Safety - organizational priorities.
• Build strong - collaborative relationships and influences without authority, contributing to an inclusive team environment.
• Deliver high-quality results with accountability and agility, translating objectives into action while continuously improving , - embracing change, and - demonstrating leadership .
• As needed, lead and/or participate in method development, inter-group initiatives, and various related scientific projects.

• Master 's degree - with training in toxicology, pharmacology, or related scientific discipline .

• Minimum of - 8 - years of relevant experience .
• Minimum of 5 years - as a Study Director in pharma, biotech, or at a CRO .
• General toxicology - GLP
  - Study Direct or - experience with varied models, routes of administration, and study designs.
• Demonstrated understanding of Good Laboratory Practices (US FDA 21 CFR Part 58).
• Strong interest in collaborating with diverse cross-functional teams and communicating openly and often with colleagues .
• Strong listening - and leadership - skills .
• Ability to communicate clearly using verbal and written formats , including presentations .

• GLP Study Director experience with varied modalities (e.g. biologics and small molecule therapeutics)
• Familiarity with outsourced study monitoring
• Familiarity with ICH safety guidelines

Animal Studies, Effective Written Communication, Evaluate Information, Good Laboratory Practices (GLPs), Oral Communications, Proactive Thinking, Study Directing, Study Monitoring, Teamwork, Toxicology

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

-We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

-We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Regular

Domestic

No

No Travel Required

Not Applicable

Not Indicated

No

N/A