• Serve as the senior clinical and scientific voice for Caris in GI/GU oncology, representing the company at national and international meetings, academic institutions, and major cancer centers. • Deliver high-impact public and scientific presentations to clinicians, researchers, and thought leaders, translating complex genomic science into clear, clinically relevant insights. • Cultivate and maintain strategic relationships with key opinion leaders (KOLs), clinical collaborators, and POA member institutions to advance the Caris mission and strengthen brand leadership in precision oncology. • Partner with internal stakeholders across R&D, Medical Affairs, Commercial, Business Development, and Marketing to ensure clinical accuracy, alignment, and innovation in messaging and product positioning. • Advise on clinical strategy and evidence generation to support Caris’ growing presence in GI/GU oncology, including input on prospective trials, retrospective analyses, and real-world data initiatives. • Contribute thought leadership to Caris’ scientific communications—advisory boards, symposia, webinars, publications, and slide decks that convey Caris’ scientific differentiation. • Provide clinical mentorship to field-based medical personnel (e.g., Medical Science Liaisons), enhancing their effectiveness in customer engagement and scientific storytelling. • Collaborate on content development for GI/GU oncology education programs, internal trainings, and professional/continuing medical education (CME) initiatives. • Bridge insights from the field to internal teams, ensuring the evolving needs of GI/GU oncologists and researchers inform product innovation and R&D priorities.

• Develop and execute system-wide strategies for pathology services aligned with laboratory and organizational priorities. • Oversee market pathology groups’ alignment to ministry goals to assure efficiency, consistency, and service excellence. • Develop and, wherever possible, standardize pathology productivity and performance metrics across the ministry. • Provide guidance to market medical directors in the development of quality assurance programs, including proficiency testing, peer review, and internal audits. • Remain abreast of evolving best practices, technologies, and regulatory requirements in pathology and laboratory medicine. • Foster transparency and collaboration among pathology groups across markets by instilling a culture of continuous improvement in pathology services. • Chair the Clinical & Scientific Board, Lab Regulatory Oversight Committee, Lab Stewardship Committee, Patient Blood Management Committee, and other enterprise-wide committees, projects, and initiatives, as assigned. • Ensure site medical directors are compliant with all federal, state, and local regulations and are in good standing with market medical operations. • Provide feedback to executive leadership team and market leadership in the performance and evaluation of site medical directors. • Participate in strategic discussions in the buy vs sell analysis of test internalization and in the evaluation of new equipment. • Participate with the executive leadership team in driving cost-effective service delivery with focus on improving quality. • Serve as a key liaison between pathology, clinical departments, hospital leadership, and external partners.

• Provide clinical leadership and oversight of all owned PACE programs • Collaborate with a variety of system-level leaders in the departments of Finance, Quality, Compliance, Informatics, Coding, Claims adjudication, Education, Credentialing and Operations • Create and maintain an atmosphere of warmth, propagating a calm environment throughout the office • Promote and maintain collaborative relationships with managers, peers, direct reports and customers • Coordinate communication with Pharmacy Benefit Manager and pharmacy provider(s) as necessary • Participate in Part D audits and development of corrective action plans • Establish expectations for Utilization Management meetings

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Head of Drug Safety will serve as the strategic and operational leader for the company’s pharmacovigilance function. This role combines medical oversight and PV scientist responsibilities with strong team leadership, ensuring robust safety surveillance for marketed products and clinical programs. The ideal candidate is an MD with deep expertise in pharmacovigilance and drug safety, capable of managing both hands-on activities and team leadership in a small, fast-paced biotech environment. Key Responsibilities - Leadership - Lead and mentor a small team of PV professionals (scientist and operational roles). - Foster a culture of compliance, scientific rigor, and continuous improvement. - Reporting to the Chief Medical Officer, contribute as a key member of the MedCORE and Genetix Leadership Teams. - Medical Oversight - Serve as the Medical Director for all marketed and investigational products. - Perform medical review and assessment of adverse event reports, including seriousness, causality, and expectedness. - Author and approve aggregate safety reports (e.g., DSURs, PBRERs, SMP/RMP updates). - Provide medical input into signal detection, risk evaluation, and mitigation strategies. - Act as the primary medical contact for regulatory authorities on safety matters. - PV Operations & Compliance - Oversee case processing activities, including timely submission of ICSRs to regulatory authorities (FAERS, EudraVigilance). - Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA). - Lead signal detection and management processes, including periodic safety reviews and safety committees. - Maintain and update PV SOPs, policies, and governance frameworks. - Manage vendor relationships for PV services and ensure quality oversight. - Cross-Functional Leadership - Collaborate with Clinical Development, Regulatory Science, Quality, and Medical Affairs to ensure integrated safety strategies. - Provide PV input into clinical trial protocols, informed consent forms, and investigator brochures. - Support labeling updates and safety sections of regulatory submissions (IND, BLA, variations). Qualifications - MD degree required; clinical experience in a relevant specialty (e.g., hematology, oncology, cell and gene therapy) preferred. - 10+ years of pharmacovigilance experience, including leadership roles. - Proven experience with post-marketing PV and clinical trial safety; experience in hemoglobinopathies or cell and gene therapy preferred. - Strong knowledge of global PV regulations (FDA, EMA, ICH); experience with interaction with regulatory authorities on safety matters preferred. - Proficiency in using electronic safety databases (i.e., Argus). - Excellent analytical, communication, and decision-making skills. - Ability to thrive in a small biotech environment, balancing strategic and hands-on responsibilities. Requirements - Base Salary Range: $326,485 - $403,382. - This role is eligible for an annual bonus and long-term incentive. - Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law. Benefits - Comprehensive health, life and disability insurance. - Employer-matched 401(k) plan. - Lifestyle spending account. - Flexible time-off + paid holidays and winter shutdown. - Tuition reimbursement & loan repayment assistance. - Paid parental leave. - Generous commuter subsidy. - And much more. Company Description Genetix 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.