--- title: 'Paralegal and Legal & Compliance Operations Manager at Genetix Biotherapeutics' canonical: 'https://feeny.ai/job/paralegal-and-legal-compliance-operations-manager-genetix-biotherapeutics-m768zfn33tct' type: 'job' last_seen: '2026-09-07' --- # Paralegal and Legal & Compliance Operations Manager at Genetix Biotherapeutics - **Company:** Genetix Biotherapeutics - **Location:** Somerville, MA - **Compensation:** $120k–$155k - **Posted:** 2026-08-17 - **Last confirmed live:** 2026-09-07 - **Apply:** https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/8129871 ## Job description ## 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. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office. Position Description: The Paralegal and Legal & Compliance Operations Manager pairs substantive paralegal work with ownership of the operational engine behind the Legal and Compliance function. This position will manage the contract lifecycle, corporate governance records, and entity administration; execute the recurring obligations of the healthcare compliance program, including federal and state transparency reporting, engagement documentation, exclusion screening, policy administration, and training; and own the systems, calendars, metrics, and vendor relationships that allow a lean department to operate at commercial scale. This position is well suited to an experienced in-house paralegal who is seeking a broader remit than a traditional paralegal seat, or to a compliance operations professional who brings strong transactional and governance experience. The role is an individual contributor position with significant autonomy and cross-functional visibility. Job Duties and Responsibilities: Contract Lifecycle and Transactional Support (approximately 30 percent) - Serve as day-to-day administrator of the contract lifecycle management system, including intake triage, routing, template selection, version control, execution through the electronic signature platform, and post-execution filing and obligation tracking. - Prepare first drafts of routine agreements from approved templates, including confidentiality agreements, consulting and advisory board agreements, master services agreements, statements of work, speaker agreements, data use agreements, and business associate agreements. - Coordinate review across Legal, Compliance, Finance, Procurement, Quality, and Privacy, and escalate non-standard terms and playbook deviations to the responsible attorney. - Maintain the contract repository, the signature authority matrix, and the renewal and expiration calendar, and give business owners advance notice of upcoming decision points. - Support qualified treatment center agreements, payer and outcomes-based agreements, clinical trial and site agreements, and vendor onboarding documentation at the direction of the responsible attorneys. Healthcare Compliance Operations (approximately 30 percent) - Own the operational calendar for federal Open Payments reporting under the Physician Payments Sunshine Act, including data collection, validation, dispute resolution, attestation, and submission. - Administer state transparency and pharmaceutical marketing obligations, including the Massachusetts pharmaceutical and medical device manufacturer code of conduct filing, the California comprehensive compliance program declaration, and Vermont, Connecticut, Nevada, and District of Columbia requirements, together with pharmaceutical representative licensing and registration where applicable. - Manage aggregate spend data flows across Finance, travel and expense, Medical Affairs, and third-party vendors, and reconcile reported transfers of value to source records. - Process and document engagements with healthcare professionals and healthcare organizations, including needs assessments, fair market value determinations, exclusion and debarment screening, conflict-of-interest disclosures, and verification of post-engagement deliverables. - Support the intake and review workflow for grants, charitable contributions, medical education support, and investigator-initiated study requests through the applicable review committees. - Maintain the compliance policy library, including version control, scheduled periodic review, attestation tracking, and archiving of superseded versions. - Coordinate the onboarding and annual compliance training curriculum in the learning management system, and track completion, escalation, and remediation. - Prepare agendas, materials, and minutes for the Compliance Committee, and support periodic reporting to executive leadership and the Board of Directors. - Support monitoring and auditing activities, including field ride-along documentation, speaker program monitoring logistics, expense report review, and corrective action tracking. - Provide intake and administrative support for hotline reports and internal investigations under attorney direction, maintaining strict confidentiality and an accurate investigation log. Corporate Governance and Entity Management (approximately 20 percent) - Maintain corporate minute books, board and committee materials, written consents, resolutions, and officer and director records for the parent company and each subsidiary. - Manage entity housekeeping, including annual reports, franchise tax filings, foreign qualifications, registered agent relationships, certificates of good standing, and secretary certificates. - Support equity administration and capitalization recordkeeping in coordination with Finance and outside counsel. - Coordinate corporate authorizations, notarizations, apostilles, and signature packets for domestic and international transactions, including partnership and distribution arrangements outside the United States. Legal Operations and Department Management (approximately 20 percent) - Administer the matter management system, outside counsel guidelines, engagement letters, conflict waivers, rate approvals, electronic billing, invoice review, and accrual reporting. - Track department budget and spend against plan, and prepare periodic reporting for the General Counsel. - Administer legal holds and the records retention schedule, coordinate document collection and preservation, and support litigation, subpoena, and government inquiry responses under attorney direction. - Coordinate intellectual property docketing and annuity deadlines with outside patent counsel. - Support privacy operations, including data subject access requests, records of processing activities, and vendor privacy due diligence. - Evaluate, implement, and administer department technology, and build the process documentation, dashboards, and metrics that improve cycle time and visibility. Essential/Required Qualifications - Bachelor's degree, or an American Bar Association approved paralegal certificate combined with equivalent experience. - A minimum of seven years of paralegal, legal operations, or compliance operations experience, including at least three years supporting an in-house legal or compliance function. - Demonstrated experience in the pharmaceutical, biotechnology, or medical device industry, with working knowledge of the federal Anti-Kickback Statute, the False Claims Act, the Physician Payments Sunshine Act, the PhRMA Code, and Office of Inspector General compliance program guidance. - Hands-on experience administering a contract lifecycle management system and an electronic signature platform. - Demonstrated ownership of a recurring regulatory reporting obligation from data collection through submission. - Exceptional attention to detail and document discipline, with the ability to manage multiple concurrent deadlines without close supervision. - Sound judgment regarding privilege, confidentiality, and when a matter must be escalated to counsel. ## Preferred Qualifications - Experience at a commercial-stage cell or gene therapy company, or in another rare disease or specialty therapeutic setting. - Experience serving as the responsible preparer for Open Payments submission and dispute resolution. - Familiarity with patient support program structures, including hub services, copay assistance, free goods, and independent patient assistance foundations, and the compliance considerations attached to each. - Experience supporting outcomes-based agreements and the government price reporting considerations associated with them. - Experience supporting international commercial partnerships and the associated anti-corruption due diligence. - Professional certification such as Certified Compliance and Ethics Professional, Certified in Healthcare Compliance, NALA Certified Paralegal, or NFPA Registered Paralegal. - Experience at a private equity backed company, or at a company that has recently transitioned from public to private ownership. Core Competencies - Integrity and discretion, with the judgment to handle sensitive matters independently. - Plain-language communication that helps commercial, medical, and technical colleagues understand what a requirement means for their work. - A process improvement orientation, rather than a preference for maintaining what already exists. - Comfort with ambiguity and with the pace of a lean department at a company in transformation. Additional Information - Hybrid schedule based at the company's Somerville, Massachusetts headquarters, with on-site presence expected [three] days per week. - Occasional travel, estimated at less than ten percent, for company meetings, industry congresses, and monitoring activities. - Prolonged periods of computer-based work. - This position has no direct reports. - The person in this role is not authorized to practice law or to provide legal advice, and performs all substantive legal work under the supervision of a licensed attorney. Additional Information The pay transparency range provided below 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 holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more. Pay Transparency $120,000—$155,000 USD 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. ## About Genetix Biotherapeutics ## Company Overview - **One-liner**: Genetix Biotherapeutics (formerly bluebird bio) is a commercial-stage biotechnology company dedicated to developing and delivering one-time, curative genetic therapies for patients with severe rare genetic diseases. - **Entity Type**: Private (taken private in June 2025 after a sale to new ownership) - **Headquarters**: Somerville, Massachusetts, USA (with a presence in the Netherlands) - **Founded**: 1992 (founded as Genetix Pharmaceuticals; rebranded to bluebird bio in 2010; rebranded back to Genetix Biotherapeutics in September 2025) - **Founders**: Not publicly disclosed; the company was originally founded as Genetix Pharmaceuticals in 1992. ## Core Business - **Primary Industries**: Biotechnology, Gene Therapy, Rare Disease Therapeutics - **Target Customers**: B2B (healthcare providers, qualified treatment centers, payers/insurers) and B2C (patients with sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy) - **Mission**: "To transform lives through curative therapies for patients with rare, genetic diseases." ## Products & Services - **LYFGENIA™ (lovotibeglogene autotemcel / lovo-cel)**: An FDA-approved, one-time gene therapy for patients 12 years and older with sickle cell disease. It works by adding functional copies of a modified β-globin gene into the patient's own blood stem cells. - **ZYNTEGLO™ (betibeglogene autotemcel)**: An FDA-approved, one-time gene therapy for patients with β-thalassemia who require regular blood transfusions. It adds functional copies of a modified β-globin gene into the patient's own blood stem cells. - **SKYSONA™ (elivaldogene autotemcel)**: An FDA-approved, one-time gene therapy for boys with cerebral adrenoleukodystrophy (CALD), a rare, progressive genetic brain disease. It adds a functional copy of the ABCD1 gene into the patient's own blood stem cells. - **Patient Support Program**: Personalized assistance for patients and families navigating the treatment journey, including insurance questions, treatment center coordination, and one-on-one support. ## Market Standing - **Valuation/Market Cap**: Not publicly disclosed (privately held after take-private transaction in June 2025) - **Key Metrics**: - **Annual Revenue**: Not publicly disclosed (but the company reported strong revenue growth in 2025 and achieved its **first ever profitable quarter** in that year) - **Total Funding**: Not publicly disclosed (new investors provided "significant capital" to support operational objectives following the take-private transaction) - **Notable Investors/Partners**: New ownership group (undisclosed); manufacturing partners include **Minaris**, **Lonza**, and **MilliporeSigma** (the U.S. and Canada business of Merck KGaA, Darmstadt, Germany) - **Growth Signals**: - **2025 commercial performance**: >100 patients treated in the U.S.; >150 patients completed their first cell collection cycle; 70 active Qualified Treatment Centers (QTCs) — the largest network for hemoglobinopathy gene therapies nationwide - **2026 outlook**: Doubling manufacturing capacity by mid-2026; targeting first full year of profitability; expanding LYFGENIA label to pediatric patients <12 years of age; advancing cryopreserved apheresis to improve the treatment experience ## Competitive Advantages - **First-mover & market leader**: The only company with FDA approval for three gene therapies, and the market leader in the U.S. for hemoglobinopathy gene therapies - **Proven commercial model**: >100 patients treated in a single year demonstrates real-world commercial execution and manufacturing scale - **Decades of scientific innovation**: Over 30 years of R&D in genetic therapy, with extensive clinical data from hundreds of treated patients (including 15-year long-term follow-up studies) - **Strong access**: LYFGENIA and ZYNTEGLO have meaningful access for >90% of eligible patients with commercial or Medicaid coverage - **One-time curative approach**: Therapies are designed to treat the underlying cause of disease, offering durable, potentially life-long benefits from a single administration ## Strategic Focus - **Commercial execution & patient access**: Expanding the Qualified Treatment Center network and making the treatment journey simpler for patients and providers - **Manufacturing scale-up**: Doubling manufacturing capacity in 2026 through partnerships with CDMOs to meet growing patient demand - **Process optimization**: Implementing cryopreserved apheresis to improve the patient and provider experience - **Label expansion**: Advancing the HGB-210 Phase 3 study to bring LYFGENIA to pediatric sickle cell patients under 12 years of age - **Full-year profitability**: Targeting the company's first full year of profitability in 2026 ## Why Work Here - **Mission-driven culture**: "United by purpose" — the company is laser-focused on transforming the lives of patients with rare, genetic diseases through curative therapies - **Strong momentum**: Recently achieved first-ever profitable quarter, with rapid commercial growth and a clear plan for expansion in 2026 - **Remote/hybrid policy**: Roles are listed as both on-site (Somerville, MA) and remote (e.g., Account Manager, Gene Therapy) — flexible arrangements appear available depending on the role - **Active hiring**: 23 job postings as of the search date, spanning Commercial, Quality Assurance, Technical Operations, Medical, and Regulatory functions - **Experienced leadership**: Led by CEO David Meek (ex-Mirati Therapeutics, Ipsen) with a seasoned executive team of industry veterans, signaling strong strategic direction - **Notable perks/culture**: High-impact work at the intersection of cutting-edge science and commercial execution; opportunity to join a company in the middle of a dramatic turnaround and growth phase; patient-centric focus with a dedicated support program ## Sources 1. [genetixbiotx.com - Company website](https://www.genetixbiotx.com/) 2. [job-boards.greenhouse.io - Careers page](http://job-boards.greenhouse.io/genetixbiotherapeutics) 3. [linkedin.com - LinkedIn company page](https://www.linkedin.com/company/genetix-biotherapeutics) 4. [genetixbiotx.com - Press release: Rebrand from bluebird bio](https://www.genetixbiotx.com/press-release-2025-09-18.html) 5. [genetixbiotx.com - Press release: 2025 commercial results & 2026 priorities](https://www.genetixbiotx.com/press-release-2026-03-02.html) ## Other roles at Genetix Biotherapeutics - [Sr. Manager - IT Commercial and Medical Systems](https://feeny.ai/job/sr-manager-it-commercial-and-medical-systems-genetix-biotherapeutics-somerville-drs30kf4perv) — Somerville, MA - [Sr. Director, Regulatory Strategy](https://feeny.ai/job/sr-director-regulatory-strategy-genetix-biotherapeutics-somerville-fpj4qjceza7s) — Somerville, MA - [Manager, End User Services & Lab Support](https://feeny.ai/job/manager-end-user-services-lab-support-genetix-biotherapeutics-somerville-q2ah951d4k1c) — Somerville, MA - [Director, Regulatory Advertising and Promotion](https://feeny.ai/job/director-regulatory-advertising-and-promotion-genetix-biotherapeutics-somerville-4ykm3383hgsq) — Somerville, MA - [Regional Medical Director, Gene Therapy](https://feeny.ai/job/regional-medical-director-gene-therapy-genetix-biotherapeutics-remote-wz9vc7s3xy0n) - [Associate Manager, Quality Assurance Operations](https://feeny.ai/job/associate-manager-quality-assurance-operations-genetix-biotherapeutics-8m008cez8h16) — Somerville, MA - [Sr. Manager, Quality Assurance for Quality Control](https://feeny.ai/job/sr-manager-quality-assurance-for-quality-control-genetix-biotherapeutics-j6a4xrp93mf0) — Somerville, MA - [Director, Value Communications](https://feeny.ai/job/director-value-communications-genetix-biotherapeutics-somerville-yxp6wwwsrt3f) — Somerville, MA - [Account Manager, Gene Therapy - Pacific Northwest](https://feeny.ai/job/account-manager-gene-therapy-pacific-northwest-genetix-biotherapeutics-seattle-cdgars1xqtra) — Seattle, WA - [Director of Scientific Communications & Evidence Generation](https://feeny.ai/job/director-of-scientific-communications-evidence-generation-genetix-ddek20fjzkgt) — Somerville, MA