Associate Director, Preclinical Safety Operations
<h3><strong>Who we are:</strong></h3>
<p>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. </p>
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<h3><strong>How we work:</strong></h3>
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<li><strong>PIONEER</strong>: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.</li>
<li><strong>COLLABORATE</strong>: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.</li>
<li><strong>BELONG</strong>: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.</li>
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<h3><strong>How you’ll contribute:</strong></h3>
<p>The Preclinical Study Project Manager will coordinate and schedule preclinical studies encompassing discovery through IND-enabling and registrational activities for Toxicology, Drug Metabolism, and Pharmacokinetics (DMPK) and Bioanalytical (BioA) Functions at Kymera. This role involves interfacing with Contract Research Organizations (CROs) and internal stakeholders to manage study planning, scheduling, coordination, and progress tracking, as well as ensuring proper storage of study results.</p>
<p><strong>Study Planning and Scheduling: </strong>Collaborate with internal project team representatives and project managers to assist in the planning, conduct, and reporting of non-GLP and GLP studies in Toxicology, DMPK, and BioA functions, ensuring compliance with regulatory requirements.</p>
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<li><strong>Project Management:</strong> Oversee and manage timelines, deliverables, and documentation for Toxicology, DMPK, and BioA studies, ensuring projects stay within timelines and within scope.</li>
<li><strong>Document Storage and Archiving:</strong> Collaborate with colleagues from Toxicology, DMPK, and BioA functions to maintain organized records and ensure proper storage of study documents, data, and reports in appropriate databases and document management systems.</li>
<li><strong>CRO Coordination:</strong> Collaborate with Contract Research Organizations (CROs) to ensure timely and quality delivery of study data, including study design, data analysis, interpretation and study close out.</li>
<li><strong>Compliance:</strong> Support GLP infrastructure through quality control responsibilities and active participation in process improvement activities.</li>
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<h3><strong>Skills and experience you’ll bring:</strong></h3>
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<li>Master’s degree and 5+ years, or Bachelor’s degree and 10+ years, in a related scientific discipline such as Biochemistry, Pharmacology, Toxicology, or a related field, and experience in preclinical study management (conducting, scheduling and/or planning Toxicology, DMPK, and BioA studies) within the biopharmaceutical industry or at a CRO.</li>
<li>Proficiency in managing preclinical studies and interfacing with CROs.</li>
<li>Strong understanding of GLP regulations and other relevant regulatory guidelines.</li>
<li>Experience with project planning tools such as Smartsheet or Project</li>
<li>Experience with data management systems and electronic data capture.</li>
<li>Proven ability to anticipate challenges in study planning and implementation and to develop solutions rapidly to avoid study delays or failures without increasing costs.</li>
<li>Demonstrated ability to work collaboratively in a cross-functional team environment including, CROs, and others.</li>
<li>Excellent organizational and project management abilities.</li>
<li>Strong communication and interpersonal skills for effective collaboration with internal teams and external partners.</li>
<li>Attention to detail and problem-solving capabilities.</li>
<li>Demonstrated ability to manage multiple projects simultaneously and adapt to changing priorities.</li>
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<h3><strong>Skills and experience not an exact match?:</strong></h3>
<p>Go ahead and submit your resume (and a cover letter, if you’d like!). If this role isn't right for you, we can keep you in mind for future opportunities.</p>
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<p><strong><em><span class="ui-provider a b c d e f g h i j k l m n o p q r s t u v w x y z ab ac ae af ag ah ai aj ak">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.</span></em></strong></p>
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