Director, Clinical Operations

Kymera Therapeutics; Watertown (MA); On-site; USD 140,000 - 180,000; Full time

Job summary

A biotechnology company in Watertown is seeking a Director of Clinical Operations. This leadership role involves managing clinical operations for an immunology program, overseeing trial execution, and collaborating with internal teams. The ideal candidate has over 10 years of clinical operations experience and a strong background in regulatory compliance. This position offers a chance to impact patient lives through innovative therapies.

Qualifications

• 10+ years of experience in clinical operations within the pharmaceutical or biotechnology industry.
• Prior experience building and leading high-performing clinical operations teams.
• Expertise in global regulatory and compliance requirements for clinical research.

Responsibilities

• Oversee and manage all aspects of clinical operations for a high priority immunology program.
• Lead the strategic planning and execution of clinical trials.
• Collaborate with internal teams to ensure alignment on clinical trial objectives.

Skills

Clinical operations expertise

Strong communication skills

Problem-solving skills

Team leadership

Ability to manage priorities

Education

BA/BS in health-related field

Job description

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.

How you'll make an impact:

The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a high priority immunology program. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III).

• Lead and oversee the strategic planning, implementation and execution of clinical trials across a key immunology program in accordance with project timelines, budget, and quality standards
• 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, Translational Medicine 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
• 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
• Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity
• 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 program 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 field
• 10+ 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

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.