We are seeking a Director, Data Management to oversee the quality of outsourced Data Management activities for Clinical Trials ranging from Phases I to III. This person will initially serve as the lead data manager for our three (3) ongoing Phase 1 oncology studies. The responsibilities will also include building internal Data Management infrastructures and hiring and retaining additional team members in the Data Management group as need.  This position will report to VP, Head of Biometrics and be located in the Watertown, MA office.

Kymera Therapeutics is a publicly listed, clinical stage biotechnology company pioneering the field of targeted protein degradation (TPD) to bring life-changing medicines to patients that need them. Kymera’s Pegasus™ TPD platform harnesses the body’s natural protein recycling machinery to degrade disease-causing proteins, with a focus on undrugged nodes in validated pathways currently inaccessible with conventional therapeutics. As we work toward becoming a fully-integrated biopharmaceutical company, we are growing and strengthening organizational capabilities and evolving our culture. As a result, Kymera has been recognized by both the Boston Globe and the Boston Business Journal as one of Boston’s top workplaces.

In 2023, we plan to continue to advance our leadership in TPD and enhance our capabilities to deliver on the potential of inventing a new class of protein degrader medicines for patients. Kymera is rapidly advancing four clinical stage programs in oncology and immunology, and is positioned to deliver one additional Investigational New Drug Applications (IND) annually. We are also actively advancing a broad pipeline of preclinical programs where TPD has the potential to provide a best-in-class approach, both internally and in collaboration with our partners Sanofi and Vertex Pharmaceuticals.

Responsibilities:

• Manage and oversee vendors, contractors and internal personnel on data management activities for all clinical studies. Accountable for external vendor timeline management.
• Build and retain a world class internal data management team.
• Provide project management and technical guidance/expertise to ensure operational and technical excellence.
• Manage aspects of data management activities, including oversight on vendor performance, internal metrics, quality assurance checks and communication of trial status within and outside the trial team
• Develop, implement, and version DM processes and standards.
• Review, and comment on CRFs, annotated CRFs, and edit checks and related documents.
• Collaborate with biostatistics, programming, and clinical to provide DM support.
• Could serve as a lead data manager for a pivotal project if needed.

Qualifications:

• Minimum of 10 years of experience in data management, with 5 years in oncology preferred.
• 3 years of people management experience, including the training and development of personnel.
• Master’s degree in life sciences, pharmacy or related discipline preferred.
• Expert proficiency, complete knowledge and understanding of DM and processes, procedures, and roles.
• Demonstrated proficiency managing the lifecycle of clinical data projects.
• Extensive experience in BLA, NDA/s NDA regulatory submissions
• Experience in developing and implementing SOPs.
• Possess a thorough knowledge of medical terminology and the clinical trial process including extensive knowledge of biostatistics, data management, pharmacovigilance and clinical operations functions.
• Proficient in developing requests for proposals for external vendor contracts and in evaluating external vendor capabilities.
• Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company.
• Demonstrate effective time management and organizational skills including the ability to work under deadlines and on multiple projects simultaneously.
• Willingness to roll up his/her sleeves and get things done.

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, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.