- 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, Biostatics, 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
- In collaboration with the Head of Clinical Operations, hire, train and develop the Clinical Operations team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence
- BA/BS preferably in a health-related field; preferred MA/MS degree with major in biological, life science, nursing or related field
- 10 + years of experience in clinical operations management within the pharmaceutical or biotechnology industry
- Prior experience building and leading a team is a plus
- 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
- Strong communication, interpersonal, and problem solving skills
- Must be comfortable working in a fast-paced environment
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Director, Clinical Operations - Watertown, United States - Kymera Therapeutics, Inc.
3 weeks ago
Description
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.
Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on delivering oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
Kymera is also progressing degrader oncology programs that target undrugged or poorly drugged proteins to create new ways to fight cancer.
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 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 contribute:
The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a key immunology program.
This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across multiple disciplines to drive a key program with multiple studies and indications through all phases of clinical trials (Phase I-III).
The Director will be a leader in the Clinical Development organization who knows how to manage a team internally, at our clinical sites, and with our vendors.
What skills and experience you'll bring:
Skills and experience not an exact match?:
Go ahead and submit your resume (and a cover letter, if you'd like). If this role isn't right for you, we can keep you in mind for future opportunities.
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.
