Genetix Biotherapeutics

Lead and oversee pharmacovigilance activities, ensuring compliance and safety for biotech products, and collaborate with cross-functional teams. | Requires an MD with 10+ years in pharmacovigilance, experience with global PV regulations, and team leadership in a biotech or pharmaceutical setting. | About Genetix Biotherapeutics At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values: Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care. SUMMARY The Senior Director of Pharmacovigilance will serve as the strategic and operational leader for the company’s pharmacovigilance function. This role combines medical oversight and PV scientist responsibilities, 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. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office but will consider Remote. Why Join Us? Opportunity to shape the PV function in a biotech with approved products. Work on cutting-edge gene therapy treatments that make a real difference. Collaborative, mission-driven culture with room for innovation and impact. RESPONSIBILITIES 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). Team Management Lead and mentor a small team of PV professionals (scientist and operational roles). Foster a culture of compliance, scientific rigor, and continuous improvement. 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. 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.

Implement and manage payer engagement strategies, negotiate value-based agreements, and collaborate with treatment centers to ensure patient access to gene therapies. | Extensive experience in biotech/pharma market access, deep understanding of US payer landscape, established relationships with healthcare payers and stakeholders, and success in negotiating outcomes-based payment models. | About Genetix Biotherapeutics At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values: Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care. SUMMARY Genetix Biotherapeutics' Market Access, Advocacy + Policy (MAAP) team is dedicated to helping patients access our innovative gene therapies. We're seeking a mission-driven National Account Executive to implement the strategic direction and execution of all payer engagements and access initiatives to ensure timely and sustained reimbursement for the company's gene therapy portfolio. The National Account Executive is responsible for engaging commercial and government payers, executing innovative value-based agreements, and partnering with treatment centers to streamline access pathways. The ideal candidate brings deep expertise in payer strategy and engagement, contracting, treatment center collaboration, and leadership within specialty or gene therapy markets, coupled with a passion for ensuring patients can access transformative, one-time treatments. As a member of the Market Access Advocacy and Policy team (MAAP) you will be working alongside some of the most committed, creative, and experienced individuals in the cell and gene therapy industry to break new ground so that patients can access our FDA-approved gene therapies—patients who often have no therapeutic alternatives to battle progressive, debilitating, and life-shortening diseases. We are passionate about the science behind our gene therapies and the tremendous value we believe these one-time administered, potentially curative therapies bring to patients, their families, the healthcare system, and society overall. Everyone on our team has external-facing responsibilities, so we aim to be integrated and data- and evidence-driven to capitalize on the dynamic flow of information and insights across stakeholders (always being sure to maintain the highest standards of compliance). Join us if you work best in a fast-paced and highly collaborative environment! RESPONSIBILITIES • Meet access goals and ensure medical coverage pathways are consistent with FDA approved prescribing information • Collaborate with Qualified Treatment Center (QTC) Account Liaisons, Marketing, Patient Support Team and Medical Value Liaisons and other Genetix stakeholders to identify access barriers and ensure patient access • Implement strategies and tactics to support individual patient access and reimbursement (e.g., coverage, coding) across payer segments • Serve as the primary, regional point-of-contact for Genetix's Qualified Treatment Center network for all market access-related issues. Proactively educate QTC around state Medicaid and commercial payer coverage criteria, PA process and requirements as well as addressing account specific educational gaps in our treatment process and pathway. Create confidence in the access pathway for our therapies by leveraging published medical policies and patient approvals across the QTC network and aligning all messaging to our market access engagement strategy • Develop and maintain core relationships with the business functions at Genetix's QTCs with a focus on patient pull through, including but not limited to, managed care contracting, CFO and revenue cycle, government affairs, billing department leads, along with hospital quality and legal teams, gene therapy coordinators, financial coordinators and PA and appeals support • Proactively work in a preventative measure with QTCs to establish hygienic PA submissions to alleviate incomplete submissions or administrative inaccuracies • Consistently engage National and Regional commercial payers, FFS and Managed Medicaid plans, and Federal payers to positively influence decision makers in areas of clinical criteria and medical policy. Present, negotiate and execute Value Based Agreements (VBA) at the payer level to facilitate timely access to FDA-approved Genetix therapies • Negotiate and manage value contracts with assigned payers for optimal Genetix product access • Respond to ad hoc requests by small regional payers in assigned territory • Work within the payer ecosystem to identify delays or friction in the approval process, develop a plan, and implement a timely resolution. Provide support and pull through strategies to the QTCs when to overcome delays within the process ex: PA requirements and any PA denials, distribution channel preference etc. • Educate QTCs with Letter of Intent on considerations for case rate agreements to reduce delays. Connect QTCs with other QTCs for best practice sharing or connect them with appropriate decision makers at the health plan for issue escalation and resolution. • Identify and leverage contacts within the payers and connect those payer stakeholders with the QTC to streamline PA review and approval processes • Work cross-functionally within the POD team structure to ensure alignment across Genetix's stakeholders and that QTCs receive surround sound support at every step in the patient journey; these cross functional partners include: apheresis, patient support, field medical, legal and contracting, and working closely with the QTC account leads to mitigate and/or remove barriers to care at the consult and treatment phases of the patient journey. • Work closely with Medical Value Liaison (MVL) in tandem for targeted situations e.g. PA prep, appeals, policy and coverage influence • Share insights and feedback from across market access stakeholders (with a focus on payers and financial decision makers at QTCs) • Encourage and facilitate QTC patient's enrollment into Genetix's patient support program My Bluebird Support (MBS) to enrich the patient treatment journey • Maintain the utmost standard of professionalism and compliance in all internal and external engagements QUALIFICATIONS • 10 years of experience in the biotech/pharma field with a bachelor's degree required; master's degree in a relevant health or finance related field preferred • A track record of success engaging tertiary and quaternary clinical and research institutions and integrated delivery networks on market access issues • Comprehensive understanding of the current and evolving US payer landscape within cell and gene therapies or complex therapies from a both medical and pharmacy benefit perspective • Strong clinical aptitude/acumen • Deep knowledge of U.S. markets and understanding of Commercial Payers, PBMs, Stop Loss and Reinsurance and Government Payers (FFS and Managed Medicaid, Medicare, and TRICARE) • Established relationships with Pharmacy Directors, Medical Directors, and other key stakeholders with assigned accounts • Demonstrated knowledge and specialty pharmacy and buy and bill procurement models across commercial and government payers; recent experience preferred • Demonstrated expertise as a subject matter expert (SME) for assigned key payer accounts with experience in navigating complex vertically integrated orgs • Experience negotiating and implementing outcomes-based or other alternative payment models preferred • Exceptional customer business planning, tactical planning, and successful execution skills • High degree of attention to detail including proven ability to manage multiple, competing priorities • Travel 50% Additional Information: Base Salary Range: $204,000 - $271,000 The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. 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. Genetix's total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include 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. 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.