Senior Director - Clinical Operations

1w1 week ago

Kymera Therapeutics

Watertown, US · Full-time · $235,000 – $330,000

About this role

Kymera is a clinical-stage biotechnology company pioneering targeted protein degradation to address immunological diseases with oral small molecule degraders. The Senior Director, Clinical Operations leads all aspects of clinical operations for a high-priority immunology program. This role drives multiple studies and indications through Phase I-III trials.

Oversee strategic planning, implementation, and execution of clinical trials in line with timelines, budgets, and quality standards. Develop comprehensive program project plans covering protocols, enrollment, and risk mitigation. Manage teams internally, at clinical sites, and with vendors.

Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine, and Program Leadership for alignment. Serve as point of contact for CROs and vendors to ensure performance and contract adherence. Maintain compliance with regulatory requirements, ICH-GCP, and company SOPs.

Oversee clinical trial data collection, analysis, and interpretation with relevant teams. Contribute to clinical study documents like Investigator Brochure, INDs, protocols, and NDAs. Thrive embodying PIONEER, COLLABORATE, and BELONG values in a top Boston workplace.

Requirements

Clinical operations expertise with a track record of success
Experience driving programs with multiple studies and indications through Phase I-III clinical trials
Ability to work with peers and stakeholders across multiple disciplines
Proven leadership managing internal teams, clinical sites, and vendors
Expertise in clinical trial strategic planning, budgets, timelines, and risk mitigation
Knowledge of regulatory requirements, ICH-GCP, and SOP compliance
Cross-functional collaboration in clinical development and program leadership
Familiarity with immunology program operations

Responsibilities

Lead and oversee the strategic planning, implementation and execution of clinical trials across a key immunology program
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, Translational Medicine and Program Leadership
Provide operational expertise and strategic input into the development of Clinical Development Plans
Serve as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements
Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs
Oversee the collection, analysis and interpretation of clinical trial data
Contribute to the preparation and review of clinical study documents including Investigator Brochure, INDs, study protocols, and NDAs

Benefits

Recognized as one of Boston’s top workplaces for the past several years
Pioneer courageous, resilient mission to improve patients’ lives through degrader medicines
Value trust, transparency, data-driven decisions, and genuine camaraderie
Embrace differences with curiosity, inclusivity, ensuring people are valued, seen, and heard