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Senior Director, Clinical Operations

$235k - $330k

Kymera Therapeutics

About Kymera 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. 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. Senior Director, Clinical Operations As a leadership role, the Senior Director, Clinical Operations oversees and manages all aspects of clinical operations for the Phase 3 program of a high‑priority immunology program, KT‑621. This individual is accountable for driving the cross‑functional strategy and rigorous operational execution through regulatory approval. The Senior Director will be a leader in the organization who knows how to hire and manage a team internally, at clinical sites, and with vendors. Responsibilities Lead and oversee the strategic planning, implementation and execution of late‑stage clinical trials across a key immunology program in accordance with project timelines, budget, and quality standards (including ICH GCP and local regulations). Develop and manage comprehensive program project plans, including study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies. Collaborate cross‑functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics and Program Leadership to ensure alignment on clinical trial objectives and milestones. Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program. Accountable for robust operational strategies for all studies in the Phase 3 program, ensuring consistency as needed, including country and site mix, PR&R and Site Engagement strategies, vendor strategy, risk‑based and site monitoring strategies, etc. Serve as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards. Ensure compliance with regulatory requirements, ICH‑GCP requirements, and company SOPs throughout all stages of clinical trial conduct. Accountable for inspection readiness and provide 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‑621 Phase 3 team, fostering a culture of collaboration, accountability, continuous improvement and operational excellence. Skills and Experience BA/BS, preferably in a health‑related field. 12+ years of experience in clinical operations within the pharmaceutical or biotechnology industry. Prior experience building and leading a high‑performing clinical operations team. Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CRF, EU CTD and ICH GCP. Ability to manage multiple competing priorities and adapt to changes in a high‑pressure environment. Strong communication, interpersonal, and problem‑solving skills. Comfortable working in a fast‑paced environment. Equal Employment Opportunity Kymera Therapeutics is proud to be an equal‑opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class. 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 $235,000 - $330,000, 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. #J-18808-Ljbffr

Vacancy posted 3 days ago
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