---
title: 'Director, Regulatory Advertising and Promotion at Genetix Biotherapeutics'
canonical: 'https://feeny.ai/job/director-regulatory-advertising-and-promotion-genetix-biotherapeutics-somerville-4ykm3383hgsq'
type: 'job'
last_seen: '2026-09-07'
---

# Director, Regulatory Advertising and Promotion at Genetix Biotherapeutics

- **Company:** Genetix Biotherapeutics
- **Location:** Somerville, MA
- **Compensation:** $185k–$285k
- **Posted:** 2026-08-24
- **Last confirmed live:** 2026-09-07
- **Apply:** https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/8129150

## 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 Director, Regulatory Advertising & Promotion is responsible for leading U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure promotional materials are compliant with regulatory requirements and aligned with corporate and commercial objectives.

The Director serves as a key regulatory partner to Medical Affairs, Commercial, Marketing, and Legal, and plays a central role in promotional material review in a highly regulated environment, for cell and gene therapy products.

Job Duties and Responsibilities:

Advertising and Promotion

- Oversee regulatory review of US promotional and select non-promotional materials across channels, ensuring compliance with FDA regulations and enforcement trends
- Serve as the regulatory lead and reviewer for Medical-Legal-Regulatory (MLR) review
- Partner with Commercial, Medical Affairs and Legal to proactively identify and mitigate regulatory risk in promotional strategy and execution
- Monitor and interpret FDA enforcement actions and policy developments related to advertising and promotion, translating insights into internal guidance and best practices.
- Develop submission strategy for efficient and appropriate health authority review of promotional materials; and ensure the compliant and timely submission of promotional materials to Health Authorities.
- Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions.

Governance, Process and Compliance

- Develop, maintain, and improve SOPs, workflows, tools, and training related to Ad/Prom review.
- Escalate issues related to MLR reviews and approvals, as needed.
- Drive consistency and operational excellence.

Essential/Required Qualifications:

- Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree) and strong scientific background
- Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies.
- Experience supporting FDA interactions related to promotional compliance
- Experience with MLR review
- Prior experience in cell and gene therapy or rare disease is strongly preferred.
- Proven ability to lead cross-functional teams and to operate in a matrixed organization, including leadership without direct authority.
- Deep understanding of FDA regulations and guidance governing promotional materials
- An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.
- Excellent English written and verbal communication skills.
- Ability to influence without authority and partner effectively with senior leaders.
- Strong attention to detail and accuracy with sound judgement and risk-based decision making.
- Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines, motivates others, demonstrates tact and diplomacy, and has a flexible and positive solution-oriented approach.

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 $185,000—$285,000 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
- [Regional Medical Director, Gene Therapy](https://feeny.ai/job/regional-medical-director-gene-therapy-genetix-biotherapeutics-remote-wz9vc7s3xy0n)
- [Paralegal and Legal & Compliance Operations Manager](https://feeny.ai/job/paralegal-and-legal-compliance-operations-manager-genetix-biotherapeutics-m768zfn33tct) — Somerville, MA
- [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