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Kymera Therapeutics — Watertown, New York
Who We Are
: 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. com or follow us on X (formerly Twitter) or LinkedIn . How we work: PIONEER : We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
COLLABORATE : We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine. BELONG : We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.
How you’ll make an impact: The Senior Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for the Phase 3 program of a high priority immunology program, KT-621. This individual will be accountable for driving the cross-functional strategy and rigorous operational execution through regulatory approval. This person possesses clinical operations expertise with a track record of success, working with peers and stakeholders.
The Senior Director will be a leader in the organization who knows how to hire and manage a team internally, at our clinical sites, and with our vendors.
Requirements
, ICH-GCP
, and company SOPs throughout all stages of clinical trial conduct Accountable for inspection readiness and provides appropriate guidance to Clinical Study Leads in support of inspection activities Contribute to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports Hire, train and develop the Clinical Operations KT-621Phase 3 team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence Skills and experience you’ll bring: BA/BS, preferably in a health-related