Senior Manager or Associate Director, Translational Medicine Operations

Kymera Therapeutics•Watertown, MA

14d•$145,000 - $240,000

About The Position

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years.

Requirements

7–10+ years of experience in Translational Medicine Operations, Clinical Sample Management, Biomarker Operations, or a related drug development function within the biotechnology, pharmaceutical, or CRO industry.
Bachelor's degree in Life Sciences, Biology, Biomedical Sciences, Clinical Laboratory Science, or a related discipline required.
Demonstrated experience managing end-to-end biospecimen operations for Phase I–III clinical trials, including sample collection, processing, shipment, tracking, reconciliation, and study closeout.
Proven ability to manage central laboratories, specialty laboratories, and external vendors, including study start-up, laboratory manual review, kit management, performance oversight, and issue resolution.
Experience developing biospecimen operational documents such as laboratory manuals, sample management plans, collection guidelines, and processing instructions.
Strong understanding of clinical trial operations and collaboration with Clinical Operations, CROs, clinical sites, and Clinical Research Units (CRUs).
Experience overseeing vendor contracts, scopes of work, budgets, and cross-functional partnerships with Legal, Procurement/Sourcing, and Finance.
Experience managing sample deviations and ensuring sample and data integrity.
Knowledge of GCP, ICH guidelines, biospecimen chain of custody, sample handling best practices, and applicable regulatory requirements.
Experience using sample tracking systems, Smartsheet, or similar operational tools.
Excellent project management skills with the ability to prioritize multiple studies, manage timelines, identify risks, and drive cross-functional alignment.
Experience working in a fast-paced biotechnology environment with evolving clinical development programs.

Nice To Haves

Advanced degree (MS, MPH, or PhD) preferred but not required.
Experience supporting early-phase (Phase I/II) immunology, where translational endpoints are a major focus.
Experience with pharmacodynamic assays, flow cytometry, genomics, transcriptomics, IHC or other biomarker platforms.
Familiarity with assay validation activities and laboratory technology transfers.

Responsibilities

Lead Translational Medicine (TM) operations for clinical studies, overseeing end-to-end biospecimen management from study start-up through closeout.
Develop and execute biospecimen operational strategies, including collection, processing, handling, shipment, tracking, reconciliation, and archival activities.
Manage central laboratory and vendor operations, including study setup, contract management, laboratory documentation, assay support, kit management, and performance oversight.
Partner cross-functionally with Translational Medicine, Clinical Operations, Biomarker Scientists, CROs, CRUs, and external vendors to ensure successful execution of biomarker and biospecimen activities.
Oversee site operational readiness by supporting study start-up, investigator site training, biospecimen collection procedures, and ongoing site issue resolution.
Monitor biospecimen quality and data integrity by managing sample deviations, resolving operational issues, conducting root cause analyses, and implementing corrective and preventive actions.
Lead operational execution for complex, multi-site clinical studies by proactively identifying risks, managing escalations, and implementing mitigation strategies to ensure study timelines and objectives are achieved.
Ensure compliance with study protocols, regulatory requirements, and company standards while driving continuous process improvements across Translational Medicine operations.
Demonstrated experience leading, developing, and mentoring high-performing teams, including direct people management and performance development.
Experience leading cross-functional teams and influencing stakeholders in a matrixed organization without direct reporting authority.