Senior Clinical Trial Manager

Regulatory Toolkit; Massachusetts; Sur place; USD 145 000 - 215 000; Plein temps

Avantages offerts par ce poste

Competitive compensation

Equity participation

Bonus eligibility

Résumé du poste

Kymera Therapeutics is seeking a Senior Clinical Trial Manager to oversee global Phase 2/3 trials from planning through execution. You will manage cross-functional teams, vendors, and sites to ensure timely enrollment and data integrity while maintaining regulatory compliance and patient safety.

You will bring a BS in Life Sciences with 7+ years in biotech/pharma, strong PM skills, and experience with ICH GCP and HIPAA.

Qualifications

• Bachelor of Science in Life Sciences and 7+ years as a project/clinical trial manager in biotech/pharmaceutical industry.
• Experience working on large, global, complex Phase 2/3 clinical trial(s).
• Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects.

Responsabilités

• Contribute to planning, implementation and execution of a global clinical trial.
• Manage vendors to support clinical trial execution.
• Lead study meetings and provide study-specific training to staff and CROs.
• Ensure data integrity, timely enrollment, and site monitoring.
• Collaborate with data management and translational teams to summarize safety/efficacy data.

Connaissances

Clinical trial management

Global trials

Regulatory knowledge

Formation

Bachelor's degree in Life Sciences

Description du poste

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 protocols and 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 7+ years as a project/clinical trial manager in biotech/pharmaceutical industry.
• Experience working on large, global, complex Phase 2/3 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 $145,000 – $215,000, 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.