Senior Manager or Associate Director, Preclinical Safety Study Monitor
Kymera Therapeutics
August 19, 2026
Remote friendly (Watertown, MA)
United States
Clinical Research and Development
How you’ll make an impact:
Kymera Therapeutics seeks a Senior Manager or Associate Director, Preclinical Safety Study Monitor to serve as the study-level scientific and operational lead for outsourced nonclinical safety studies, ensuring high-quality, timely, inspection-ready execution.
Responsibilities:
- Liaise with CRO study directors and personnel for GLP and non-GLP toxicology studies (single- and repeat-dose, DRF, and specialized designs).
- Provide scientific input to CRO on protocols and protocol amendments; ensure alignment with program strategy and regulatory expectations.
- Monitor in-life study conduct via site visits, in-life reviews, and routine CRO communication; review emerging data and escalate quality issues.
- Contribute during protocol development, pre-study meetings, dose selection, in-life reviews, necropsy, and pathology/TK reviews.
- Own execution against critical timelines; identify risks and implement mitigations with internal partners and CRO.
- Review draft toxicology reports for accuracy/completeness/internal consistency; coordinate comment resolution.
- Maintain audit-ready study files in document systems (e.g., Veeva, SharePoint).
- Coordinate with Preclinical Study Manager, Project Toxicologist, DMPK, Bioanalytical, CMC, and others.
- Assess protocol deviations and conduct issues for scientific/regulatory significance and determine escalation.
- Represent Preclinical Safety on cross-functional teams; communicate status, risks, and interpretation.
Skills and experience you’ll bring:
- BS/MS in Toxicology, Pharmacology, Biology, Veterinary Science, or related.
- 7+ years nonclinical safety experience; incl. significant toxicology study conduct/direction. Minimum 3 years monitoring outsourced GLP toxicology at CRO or sponsor.
- Experience managing GLP/non-GLP toxicology (repeat-dose; rodent and nonrodent) from protocol to final report.
- Strong GLP knowledge, regulatory compliance, and animal welfare related to toxicology studies.
- Ability to identify and resolve/escalate scientific, operational, quality, and regulatory risks.
- Excellent organizational and communication skills; ability to manage multiple studies and partner with CROs.
- Travel to CRO sites as needed (typically 5–10%).
Compensation:
- Base salary range: $145,000–$240,000; eligibility for annual bonus, equity participation, and comprehensive benefits.
Kymera Therapeutics seeks a Senior Manager or Associate Director, Preclinical Safety Study Monitor to serve as the study-level scientific and operational lead for outsourced nonclinical safety studies, ensuring high-quality, timely, inspection-ready execution.
Responsibilities:
- Liaise with CRO study directors and personnel for GLP and non-GLP toxicology studies (single- and repeat-dose, DRF, and specialized designs).
- Provide scientific input to CRO on protocols and protocol amendments; ensure alignment with program strategy and regulatory expectations.
- Monitor in-life study conduct via site visits, in-life reviews, and routine CRO communication; review emerging data and escalate quality issues.
- Contribute during protocol development, pre-study meetings, dose selection, in-life reviews, necropsy, and pathology/TK reviews.
- Own execution against critical timelines; identify risks and implement mitigations with internal partners and CRO.
- Review draft toxicology reports for accuracy/completeness/internal consistency; coordinate comment resolution.
- Maintain audit-ready study files in document systems (e.g., Veeva, SharePoint).
- Coordinate with Preclinical Study Manager, Project Toxicologist, DMPK, Bioanalytical, CMC, and others.
- Assess protocol deviations and conduct issues for scientific/regulatory significance and determine escalation.
- Represent Preclinical Safety on cross-functional teams; communicate status, risks, and interpretation.
Skills and experience you’ll bring:
- BS/MS in Toxicology, Pharmacology, Biology, Veterinary Science, or related.
- 7+ years nonclinical safety experience; incl. significant toxicology study conduct/direction. Minimum 3 years monitoring outsourced GLP toxicology at CRO or sponsor.
- Experience managing GLP/non-GLP toxicology (repeat-dose; rodent and nonrodent) from protocol to final report.
- Strong GLP knowledge, regulatory compliance, and animal welfare related to toxicology studies.
- Ability to identify and resolve/escalate scientific, operational, quality, and regulatory risks.
- Excellent organizational and communication skills; ability to manage multiple studies and partner with CROs.
- Travel to CRO sites as needed (typically 5–10%).
Compensation:
- Base salary range: $145,000–$240,000; eligibility for annual bonus, equity participation, and comprehensive benefits.