We are seeking an experienced clinical trial manager to join our team at Kymera Therapeutics. The ideal candidate will successfully plan, implement, and execute all areas of clinical studies. The Clinical Trial Manager will interface with other department representatives as well other departmental leaders within the organization, thus, be a key member of the Clinical Development team. This individual will oversee and drive cross-functional leadership and expertise to ensure effective contribution, execution and delivery of study activities as per quality, plan/timelines and budget for one study or more within a clinical program(s)
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:
- Manages all clinical aspects of study including:
- Uses operational and therapeutic expertise to optimize trial design and execution.
- Typically works with the department leadership to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure appropriate patient recruitment
- Proactively identifies and resolves clinical project issues
- Responsible for selection, qualification, and management of vendors to support clinical trial execution
- Develops and manages comprehensive study timelines and metrics and ensures completion of study deliverables
- Provides study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel;
- Plans, executes, and leads study-specific meetings (e.g., internal core team meetings, investigator meetings, Advisory Committee)
- Participates in site monitoring visits as appropriate
- Provides input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc
- Reviews monitoring reports to ensure quality and resolution of site-related issues
- Ensures tracking and review of protocol deviations and assesses impact on study data
- Develops relationships with investigators and site staff; critical to be comfortable engaging KOLs in scientific discussion
- Responsible for review, analysis and interpretation of clinical data
- Proactively review individual data points and data listings to identify signals or trends
- Work closely with CRO and Medical Monitor to ensure safety and efficacy data appropriately summarized to facilitate review
- Working closely with translational medicine team, ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review
- Preparing data summaries and presenting to internal and external stakeholders
Qualifications:
- Bachelor’s degree in a health-related field; preferred MA/MS degree with major in biological, life science, nursing or related field.
- 4+ years as a project/clinical trial manager, biotechnology experience is highly desirable.
- Experienced in managing early development phase clinical trials, immuno-oncology trials experience preferred.
- Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects.
- Management of overall project timeline
- Strong leadership skills
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.