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. 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:
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PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
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COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
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BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.
How you’ll contribute:
- Provide operational and implementation expertise to Kymera’s project teams to enable timely progression of clinical development programs
- Clinical trial operational lead for clinical development program ensuring successful planning, implementation and conduct of all assigned clinical trials
- Oversee and manage the CRO to ensure timelines of clinical development plans are met
- Work with the project team to identify and evaluate issues in the program, interpret data on complex issues and suggest and implement solutions
- Participate in design and development of clinical trial protocols
- Provide oversight for development of specific study documents (informed consent forms, study guidelines, operation manuals & training materials)
- Oversee and assist with the development of the clinical components of regulatory submissions
- Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites
- Oversee and manage clinical development program budget
- Work on complex program issues in which analysis of situations or data require an in-depth evaluation of various factors
- Ensure that goals and objectives for clinical development programs are met by providing strategic and tactical input by developing study specific goals, tracking metrics, producing and presenting summary reports
- Prepare and present clinical development trial updates to project teams and management and review any potential issues or recommendations
- Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines
- Write and review clinical documents such as protocols, trial reports and SOPs consistent with GCPs and other applicable government and regulatory standards
- Lead and mentor others in Clinical Operations
Skills and experience you’ll bring:
- BA/BS in a scientific field of study with 8+ years of relevant experience working in in the pharmaceutical/ biotech industry; I&I experience strongly preferred
- In-depth understanding of industry standards and applicable guidelines; FDA regulations and ICH GCP knowledge
- Experience in developing Clinical Operations SOPs and metrics
- Proven leadership experience with the desire and ability to work in a fast-paced, matrixed, start-up environment
- Strong collaboration and team-working, communication and organizational skills required
- Strong problem solving and analytical skills necessary
- Ability to prioritize and manage time demand, incomplete information, and unexpected events
- Willing to travel domestically and internationally
This position is based in Watertown, MA, and offers a hybrid work model with a minimum of 3 days/week in the office.
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.
