Senior Director, Clinical Operations

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. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.

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.

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.

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 but not limited to, 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 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

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

Must be 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.