Senior Clinical Trial Associate

Kymera Therapeutics; Watertown (MA); Presencial; USD 85.000 - 155.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Equity participation

Comprehensive benefits

Descripción de la vacante

Kymera Therapeutics in Watertown, MA is seeking an experienced Clinical Trial Manager to plan, implement and oversee global trials. You will manage vendors, lead study meetings, and ensure timely enrollment, data integrity and safety reviews to support decision making.

Requirements include a Bachelor of Science in Life Sciences and 5+ years in biotech/pharmaceutical trial management, plus experience on large Phase 2 trials, knowledge of ICH GCP and HIPAA, and proven leadership in

Formación

• Bachelor of Science in Life Sciences and 5+ years as a project/clinical trial manager in biotech/pharmaceutical industry.
• Experience working on large, global, complex Phase 2 clinical trials.
• Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects.
• Strong project management skills with the ability to manage multiple trials simultaneously.
• Excellent problem-solving, leadership, and communication skills.
• Ability to work in a fast-paced, dynamic environment with cross-functional teams.

Responsabilidades

• Plan, implement and execute a global clinical trial.
• Manage vendors to support clinical trial execution.
• Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings).
• Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
• Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.
• Manage study timelines and metrics to ensure completion of study deliverables.
• Support site selection, qualification, initiation, and monitoring activities.
• Review monitoring reports to ensure quality and resolution of site-related issues.
• Ensure timely enrollment and data collection at clinical trial sites.
• Collaborate with the data management team to ensure data integrity and timely database lock.
• Review and analyze clinical trial data to identify trends and potential issues.
• Ensure tracking and review of protocol deviations and assess impact on study data
• Develop relationships with investigators and site staff
• Work closely with CRO and Medical Monitor to ensure safety and efficacy data appropriately summarized to facilitate review.
• Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocolsand relevant data output of the trial is provided to functional groups for review.
• Maintain accurate and complete trial documentation.
• Proactively identify and resolve clinical project issues

Conocimientos

Project management

Clinical trial management

Leadership

Communication

Educación

Bachelor of Science in Life Sciences

Descripción del empleo

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. For more information about our science, pipeline and people, please visit www.kymeratx.com 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 make an impact:

• Contribute to the planning, implementation and execution of a global clinical trial
• Responsible for management of vendors to support clinical trial execution
• Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed
• Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
• Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.
• Manage study timelines and metrics to ensure completion of study deliverables
• Support site selection, qualification, initiation, and monitoring activities.
• Review monitoring reports to ensure quality and resolution of site-related issues.
• Ensure timely enrollment and data collection at clinical trial sites.
• Collaborate with the data management team to ensure data integrity and timely database lock.
• Review and analyze clinical trial data to identify trends and potential issues.
• Ensure tracking and review of protocol deviations and assess impact on study data
• Develop relationships with investigators and site staff
• Work closely with CRO and Medical Monitor to ensure safety and efficacy data appropriately summarized to facilitate review.
• Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocolsand relevant data output of the trial is provided to functional groups for review.
• Maintain accurate and complete trial documentation.
• Proactively identify and resolve clinical project issues

Skills and experience you’ll bring:

• Bachelor of Science in Life Sciences and 5+ years as a project/clinical trial manager in biotech/pharmaceutical industry.
• Experience working on large, global, complex Phase 2 clinical trial(s).
• Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects.
• Strong project management skills with the ability to manage multiple trials simultaneously.
• Excellent problem-solving, leadership, and communication skills.
• Ability to work in a fast-paced, dynamic environment with cross-functional teams.

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 $85,000 – $155,000, 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.