Senior Manager or Associate Director, Preclinical Safety Study Monitor

Kymera Therapeutics•Watertown, MA

16d•$145,000 - $240,000•Onsite

About The Position

Kymera Therapeutics is seeking an experienced nonclinical toxicology professional to join the Preclinical Safety organization as a Senior Manager or Associate Director, Preclinical Safety Study Monitor. This individual will serve as the study level scientific and operational lead for outsourced nonclinical safety studies, partnering with project toxicologists and CRO Study Directors to ensure high-quality, timely, and inspection-ready study execution.

Requirements

Bachelor's or Master's degree in Toxicology, Pharmacology, Biology, Veterinary Science, or a related life science discipline.
Approximately 7+ years of relevant experience supporting the conduct of nonclinical safety studies, including significant experience conducting or directing toxicology studies.
A minimum of 3 years of experience monitoring outsourced GLP toxicology studies at a CRO or sponsor organization is required.
Demonstrated experience independently managing GLP and non-GLP toxicology studies, including repeat-dose studies in rodent and nonrodent species, from protocol development through final report.
Strong working knowledge of Good Laboratory Practice (GLP) regulations and the conduct of nonclinical safety studies supporting global drug development, general regulatory compliance and animal welfare knowledge related to conduct of toxicology studies
Demonstrated ability to recognize scientific, operational, quality, and regulatory risks during study conduct and appropriately resolve or escalate issues to ensure study integrity and timely execution.
Excellent organizational, written, and verbal communication skills, with the ability to effectively manage multiple studies and collaborate across multidisciplinary teams and external CRO partners, in a highly dynamic, fast-paced environment.
Willingness to travel to CRO sites as needed (typically 5–10%).

Responsibilities

Serve as the primary study-level scientific and operational liaison with CRO study directors and study personnel for assigned GLP and non-GLP toxicology studies (single- and repeat-dose, DRF, and specialized study designs as needed).
Develop, review and provide scientific input to CRO on protocols and protocol amendments, ensuring alignment with program-level nonclinical strategy and applicable regulatory expectations.
Monitor in-life study conduct through site visits (in person or remote), in-life reviews, and routine communication with CRO study teams; review emerging study data, monitor study quality, and identify findings or quality issues requiring discussion or escalation.
Attend and provide scientific input during protocol development, pre-study meetings, dose selection discussions, in-life reviews, necropsy, and pathology/TK data review.
Own study execution against project-critical timelines, proactively identifying risks to deliverables and implementing mitigation strategies in collaboration with the Study Manager, the Project Toxicologist, Project Manager and the CRO.
Review draft toxicology reports for scientific accuracy, completeness, and internal consistency prior to finalization; coordinate resolution of comments with the CRO study director.
Maintain accurate, audit-ready study files and documentation in Kymera's document management system (e.g., Veeva, SharePoint).
Coordinate activities with the Preclinical Study Manager, Project Toxicologist, DMPK, Bioanalytical, CMC and other functional areas to ensure efficient execution of nonclinical studies.
Independently assess study conduct issues and protocol deviations for scientific and regulatory significance and determine when escalation to Line Management or the Project Team is warranted.
Represent Preclinical Safety on cross-functional project teams as needed, communicating study status, risks, and scientific interpretation to non-toxicologist stakeholders.