Director, Clinical Data and Systems

Kymera Therapeutics • Watertown, MA

6h • $195,000 - $275,000

About The Position

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:
Serve as clinical study team Subject Matter Expert for eCOA, IRT, Data Visualization and other clinical data systems.
Lead clinical technologies including planning, execution, and delivery of the clinical data activities on eCOA, IRT and other clinical technologies, implementing standard procedures to initiate best practices and lead data management flow.
Support the establishment of an overall clinical systems roadmap.
Partners with cross-functional team members (e.g., Clinical Operations, Clinical Science, Clinical Data Management, Tech Ops/Clin Supplies, QA, IT, Procurement) to gather relevant study requirements to create the system design, provide subject matter expertise, and ensure expert and on-time system delivery and implementation as well as data quality standards are met.
Responsible for user acceptance testing oversight and documentation, including UAT test case creation, facilitating signatures on documentation, and study risk and impact assessments.
Oversee data imports and integrations from multiple systems and ensure quality.
Responsible for facilitation of clinical system technical support, data changes, data issue resolution; working with cross-functional stakeholders including Clinical Data Management, IT, Clinical Operations and Biostatistics in order to achieve goals.
Monitor and improve data collection processes; partner to identify how to standardize data across multiple systems; provide recommendations for enriched reporting and data standards; support standardization of internal data infrastructure.
As Business Owner, ensure processes, tools, documents, and training materials related to clinical systems are developed and implemented, as needed.
Act as technical SME for contracting and budget management activities including establishing initial Scope of Work (SOW) and Change Orders in partnership with Strategic Sourcing, as applicable.

Requirements

• 10+ years of progressive experience in a Systems Management role with a Sponsor/CRO company is required.
• Ability to work independently with a high level of attention and act with initiative to address issues.
• Experience overseeing IRT/RTSM and eCOA/ePRO systems is required.
• Experience with user requirement specifications/user test scripts with clinical data systems is required.
• Experience authoring/reviewing procedures (SOPs, WIs) in a GCP environment is required.
• Experience in clinical trial conduct. Hands-on Data Management experience of EDC, eCOA and IRT.
• Effectively negotiates and influences to solve high impact challenges
• Strong leadership and project management skills, and is able demonstrate flexibility and agility working within a multi-functional, global matrix.
• Must have excellent communication skills (verbal and written), and good interpersonal/group skills.

Responsibilities

• Serve as clinical study team Subject Matter Expert for eCOA, IRT, Data Visualization and other clinical data systems.
• Lead clinical technologies including planning, execution, and delivery of the clinical data activities on eCOA, IRT and other clinical technologies, implementing standard procedures to initiate best practices and lead data management flow.
• Support the establishment of an overall clinical systems roadmap.
• Partners with cross-functional team members (e.g., Clinical Operations, Clinical Science, Clinical Data Management, Tech Ops/Clin Supplies, QA, IT, Procurement) to gather relevant study requirements to create the system design, provide subject matter expertise, and ensure expert and on-time system delivery and implementation as well as data quality standards are met.
• Responsible for user acceptance testing oversight and documentation, including UAT test case creation, facilitating signatures on documentation, and study risk and impact assessments.
• Oversee data imports and integrations from multiple systems and ensure quality.
• Responsible for facilitation of clinical system technical support, data changes, data issue resolution; working with cross-functional stakeholders including Clinical Data Management, IT, Clinical Operations and Biostatistics in order to achieve goals.
• Monitor and improve data collection processes; partner to identify how to standardize data across multiple systems; provide recommendations for enriched reporting and data standards; support standardization of internal data infrastructure.
• As Business Owner, ensure processes, tools, documents, and training materials related to clinical systems are developed and implemented, as needed.
• Act as technical SME for contracting and budget management activities including establishing initial Scope of Work (SOW) and Change Orders in partnership with Strategic Sourcing, as applicable.

Benefits

• 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 $195,000 – $275,000, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed