Kymera Therapeutics

Senior Manager or Associate Director, Preclinical Safety Study Monitor

Kymera Therapeutics • $145K — $240K *
Watertown, MA 02472In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's or Master's degree in Toxicology, Pharmacology, Biology, Veterinary Science, or related field.
  • 7+ years of relevant experience in conducting nonclinical safety studies, with 3+ years in monitoring outsourced GLP studies.
  • Proven track record of managing GLP and non-GLP toxicology studies from protocol development through reporting.
  • In-depth knowledge of GLP regulations and compliance in nonclinical safety studies.
  • Ability to identify and resolve scientific and operational risks during study execution.
  • Strong organizational, written, and verbal communication skills effective in a multidisciplinary team environment.
  • Willingness to travel (5-10%) to CRO sites.

Responsibilities

  • Serve as the main operational liaison between CRO study directors and personnel for toxicology studies.
  • Develop, review, and provide scientific input on study protocols to ensure regulatory alignment.
  • Monitor study conduct through visits and communication with CRO teams while addressing quality issues.
  • Participate in scientific discussions during protocol and dose selection meetings.
  • Proactively manage study timelines and identify risks, collaborating with the project team for mitigations.
  • Review toxicology reports for scientific correctness and coordinate feedback with CRO directors.
  • Maintain audit-ready documentation in study file management systems.

Benefits

  • Comprehensive benefits package including medical, dental, and vision insurance.
  • Eligibility for annual bonus and equity participation.
  • Supportive travel expense reimbursement for CRO site visits.
Full Job Description
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.
  • 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.
Skills and experience you'll bring:
  • 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%).
Compensation
  • Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
  • The anticipated base salary range for this role is $145,000 - $240,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
  • Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate's depth of experience and the capabilities they bring to the position.

About Kymera Therapeutics

Kymera Therapeutics is a clinical-stage biopharmaceutical company that is focused on discovering and developing novel small molecule therapeutics that selectively degrade disease-causing proteins by harnessing the body's own natural protein degradation system. The company's proprietary targeted protein degradation platform, Pegasus, is designed to harness the body's natural protein recycling machinery to degrade disease-causing proteins, with a focus on undruggable and difficult-to-drug targets. Kymera's initial programs are focused on oncology and immunology, with a goal of delivering transformative therapies for patients with previously untreatable diseases. Kymera was founded in 2015 and is headquartered in Cambridge, MA.
Learn more about Kymera Therapeutics
Size
75 employees
Market Cap
$1.4 billion
Industry
Pharmaceuticals & Biotech
Founded
2017
NASDAQ
KYMR
* Ladders Estimates

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