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.
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 contribute :
Lead development and execution of the Clinical Quality strategy while ensuring that it aligns with Kymera's business strategy, GCP / GLP / GVP standards, and FDA / EMA / ICH requirementsDevelop, implement and monitor phase appropriate GCP / GLP / GVP Quality programs, policies and procedures to ensure compliance with applicable regulationsDevelop, implement and execute a risk-based audit strategy for clinical and non-clinical studiesLead and manage GLP / GCP / GVP audits program including oversight of consultant mediated and / or self-conducted Vendor, System, Study, and Process auditProviding quality oversight and compliance support to all GLP non-clinical and clinical development programs including the development of strategic clinical quality oversight plansServe as a member of clinical study teams, providing compliance guidance, to achieve continuous quality improvement and effective quality assuranceImplement tolerance limits, metrics and key performance indicators to drive quality compliance and continuous improvementProvide day-to-day quality and compliance support, including issue management (triage / investigation / actions)Assist and advise in the development of CAPA plans in response to Quality events / audits / inspections and follow-up on CAPAsParticipate in the evaluation and selection of CROs and other GLP / GCP / GVP service providers and establish Quality Agreements, as requiredProvide training sessions and mentor teams on topics related to GLP / GCP / GVP quality and related global regulationsReview key non-clinical, safety and clinical documents including protocols / amendments, reports, study plans and regulatory documentsMaintain an inspection awareness culture leading to a successful Inspection Readiness ProgramEstablish Quality management governance and escalation structure and periodically report the state of R&D Quality and compliance to management at the Quality Management ReviewSkills and experience you'll bring :
Bachelor's degree in life sciences, nursing, or related field. Advanced degree (MS or MBA) preferredA minimum of 15 years of experience in the biopharmaceutical / pharmaceutical industryWorking knowledge of relevant FDA, EU, ICH guidelines and regulationsExperience with First in Human trial managementExtensive knowledge and understanding of ICH E6 GCP Guideline, FDA and EU RequirementsExperience and understanding of Data Integrity requirements and electronic systems used in Clinical trialsDirect experience in managing Health Authority GCP Inspections. Experience supporting BIMO inspections is preferredProven experience with developing strong partnerships with cross functional key stakeholders to ensure that strategic business goals are met through the sharing of knowledge and teamworkExtensive knowledge and understanding of all related study monitoring activitiesComprehensive understanding of the infrastructure and operational characteristics of CROs and centralized servicesStrong problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspectiveAbility to drive results on time and take ownership and accountability for shared informationStrong communication and influencing skills, as well as problem solving ability to evaluate quality matters and make decisions utilizing risk-based approachExperience with authoring and reviewing clinical regulatory filingsAbility to travel up to 15%Skills and experience not an exact match? :
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.
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.
