Position Description

The Director, Regulatory Labeling, Advertising & Promotion (LAP) is responsible for leading global product labeling and U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure labeling and promotional materials are scientifically accurate, compliant with regulatory requirements, and aligned with corporate and commercial objectives.

The position serves as a key regulatory partner to Clinical Development, Medical Affairs, Commercial, Legal, and Safety, and plays a central role in labeling strategy, lifecycle management, and promotional material review in a highly regulated environment, for cell and gene therapy products.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Job Duties and Responsibilities

Core Responsibilities:

Labeling

• Lead the development, negotiation and lifecycle maintenance of global and US product labeling, including pre- and post- approval updates.
• Drive development and maintenance of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI), ensuring alignment with global regulatory expectations.
• Establish and operationalize labeling strategies that result in clear, concise, compliant and scientifically robust product labels.
• Provide regulatory leadership for labeling-related interactions with Health Authorities, including briefing documents and responses to inquiries.
• Ensure final labeling content meets internal standards and regulatory authority requirements prior to submission or implementation.

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

• Support or co‑lead the Labeling Review Committee (LRC) and provide regulatory oversight of labeling governance processes.
• Develop, maintain, and improve SOPs, workflows, tools, and training related to labeling and Ad/Prom review.
• Ensure inspection readiness and documentation compliance for labeling and promotional activities.
• Drive consistency and operational excellence across labeling and Ad/Prom processes globally.

Cross-Functional Leadership

• Act as a strategic regulatory advisor to Clinical, Safety, Medical Affairs, Commercial, Quality, and Regulatory Strategy teams.
• Lead and mentor internal staff and manage external vendors or consultants as needed.
• Contribute to broader regulatory strategy discussions.

Essential/Required Qualifications:

• Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies.
• Experience supporting FDA interactions related to labeling and promotional compliance
• Experience with MLR review and developing Company Core Data Sheets
• 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.
• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree)
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• 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.

Key Competencies:

• Deep understanding of FDA regulations and guidance governing labeling and promotional materials.
• An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.

Position Description

The Manager, Gene Therapy Operations, is a critical role within the Patient Operations organization and is responsible for end-to-end (enrollment to infusion) oversight and execution of critical gene therapy supply chain operations for Genetix’s three commercially approved therapies.

This role partners closely with Manufacturing, Quality, Commercial Strategy & Operations, Sales, Systems Teams, and Logistics to ensure uninterrupted, world class patient and customer support.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Job Responsibilities

• Execute and manage the day-to-day supply chain and logistics operations of gene therapy from patient enrollment to infusion of drug product
• Coordinate patient scheduling with internal team, ensure scheduling tasks in associated systems and trackers are updated and communicated in a timely manner. Oversee the external CMO scheduling functions as appropriate
• Manage, maintain, and improve customer relationship with QTCs in partnership with apheresis and commercial teams
• Live monitoring and on call support during apheresis and final drug product logistics movements to ensure delivery is timely and secure
• Own and manage CMO slot utilization
• Execute tasks in accordance with all governing Policies, Standard Operating Procedures, Work Instructions, and Job Aids
• Contribute to a culture of continuous improvement, think proactively to offer solutions to problems

Required Education, Experience, and Qualifications

Required:

• Bachelor’s degree in Life Sciences, Engineering, or related discipline
• 5+ years of experience in pharmaceutical supply chain, planning, scheduling, gene therapy systems, project management, customer service and relationship management within the biotech industry
• Prior experience working in GxP regulated environments

Preferred:

• Experience within Sickle Cell Disease, Beta Thalassemia, and autologous cell and gene therapy supply chain

Key Competencies:

• Excellent attention to detail, must be able to manage and organize own work independently and in coordination with a team
• Ability to navigate systems such as Oracle, Traceability Systems, Veeva efficiently
• Excellent, clear, concise, and empathetic communication
• Able to execute tasks with a sense of urgency and manage time effectively. Must be comfortable operating in a fast-paced, evolving environment
• Ability to adapt to fluctuating relationship dynamics with internal and external partners

Position Description:

The Director, Apheresis Operations, is a leadership role within Patient Operations and is responsible for providing strategic and operational oversight of the apheresis operations team that supports Genetix’s three commercially approved therapies. This role is field based and requires frequent travel to Qualified Treatment Centers (QTC) to engage with our customers and care teams in-person. This role will develop and expand the strategic partnerships and relationships with external partners and evolve the internal team to meet the demands of our growing commercial business. The ideal candidate will enhance and expand on the existing technical and medical knowledge of the organization. The apheresis operations team is a highly skilled and technically knowledgeable group of individuals responsible for: 1) QTC onboarding, training, qualification, 2) data analytics and metric tracking on collections, 3) onsite/remote cell collection support and optimization, and 4) final Drug Product infusion support.

This role partners closely with Manufacturing, Quality, Commercial, Patient Management & Logistics, Medical, and Systems Teams to ensure uninterrupted, world class patient and customer support.

This position is a US Remote position. Domestic travel 50% or more of the time is required for this role.

Job Duties and Responsibilities:

Core Responsibilities:

• Lead, engage, evolve, and elevate the Apheresis Operations team to match evolution of our commercial business
• Extensive technical expertise, with strong focus on medical and apheresis operations experience
• Gather and analyze key data metrics, perform KPI tracking to inform continued improvements to our process and patient journey experience

Field Responsibilities:

• Travel domestically, 50% or more of the time across our national QTC network for engaging internal and external collection teams, cell therapy labs, treating physicians and teams, and patients as required to provide individualized, white glove customer service and establish partnership with teams involved
• Set the standard of relationship management and communications for the apheresis operations team, provide internal team coaching and field training

Other Responsibilities:

• Serve as subject matter expert for internal and external apheresis education
• Partner with Quality, Technical Development & Operations, and Commercial teams to build a robust treatment center network including center selection, qualification, training and ongoing support
• Oversee and drive the strategy and process improvements for QTC qualification, training, ongoing support
• Ensure compliance with regulatory standards and requirements, oversee management of team owned quality system records, (deviations, CAPAs, change controls, proactive initiatives)
• Drive the identification, sharing, and adaptation of best practices cross-functionally and between centers that will improve overall treatment experience of our patients

Essential/Required Qualifications:

Required:

• Bachelor of Science in Nursing (BSN), Registered Nurse (RN), Qualification in Apheresis (QIA) preferred, or minimally, Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)
• 10+ years of progressive experience in Apheresis Operations, Cell and Gene Therapy, Commercial Operations, Treatment Centers
• Prior people leadership experience at the Associate Director or Director level within the industry
• Demonstrated experience leading a field-based team, and working in the field
• Knowledge of GMP regulations (FDA, EMA, ICH)
• Direct apheresis experience within the last 5 years
• Domestic travel, 50% or more of the time
• Passion for bringing curative therapies to patients

Preferred Qualifications:

• Experience within Sickle Cell Disease, Beta Thalassemia, and autologous cell and gene therapy
• Experience working in BioPharma

Key Competencies:

• Primary focus on driving process improvements which have a demonstrable impact on the business
• Enhance apheresis technical knowledge, utilizing this expertise to educate internal and external groups. Key focus on how to improve collections, show up with executive presence at conferences, drive and oversee apheresis summits to be a leader in the industry
• Excellent communication and partnership with internal and external groups and individuals
• Detail oriented, anchor to and utilize data to drive sound business decisions
• Strategic thinking, with an ability to translate into operational plans
• Ability to adapt to fluctuating relationship dynamics with internal and external partners
• Excellent listening and conflict management skills. Team player, flexible to the needs of a wide range of personalities

Sr. Director, Process Development

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 hybrid position in our Somerville, Massachusetts office with regular presence in our lab facility.

SUMMARY

The Senior Director, Process Development, will provide strategic technical and operational leadership for the Process Development team within Technical Development supporting our company’s gene therapy product portfolio. This role will oversee the design and execution of process development, drive continuous improvement initiatives, advance new unit operations, and technically drive the end-to-end transfer to external manufacturing.  The role must partner successfully cross-functionally within Technical Development and across Technical Operations. 

The ideal candidate will bring deep expertise in cell and gene therapy (CGT) process development, a track record of successful prior innovations, and the leadership acumen to bridge the gap from the laboratory to routine manufacturing.

RESPONSIBILITIES

Strategy

• Provide strategic oversight and day-to-day management of process development workflows internally and externally.
• Collaborate with Analytical Sciences ensuring alignment with process development milestones and regulatory requirements.
• Propose and drive the development of continuous improvements in process, from the smallest detail in execution to an entire unit operation.
• Actively participate in establishing the appropriate technical rigor needed to support strategic decisions including appropriate utilization of small-scale models and the scale down model qualification.

Continuous Improvement and Process Optimization

• Lead a high-performing team of scientists in the design and development of process improvements, leveraging both internal experiments and external vendors.
• Drive high quality execution of rapid optimization cycles and successful comparability studies.
• Drive innovation in continuous improvement activities whether through novel unit operation development or designing the ideal custom consumable part that improves manufacturability.
• Ensure all new processes are developed with a "right first time" approach to facilitate seamless transition to a GMP environment.

External

• Acts as the ultimate technical authority for Process Development, starting with first principles and best practices for process development and extending to strategic approach externally.
• Oversight of the design and execution of external process development activities, ensuring development activities are equivalent to internal standards.

Cross-Functional Leadership & Compliance

• Collaborate across CMC to support regulatory submissions and inquiries.
• Author and review high-quality technical reports, SOPs, and CMC sections of regulatory filings.
• Build and mentor a world-class process development team, fostering individual team member development while in parallel maintaining a culture of scientific rigor and operational excellence.
• Manage resource allocation and timelines to ensure program delivery.

Qualifications

• Education: Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology or a related scientific discipline.
• Experience: 10+ years of progressive experience in the biopharmaceutical industry, with at least 5 years in a people management role specifically within Process Development for Cell and Gene Therapies.
• Technical Expertise: Deep hands-on and strategic knowledge of best practices in process development supporting cell therapy manufacturing. Ideal candidate will have prior CD34+ and/or viral vector experience. Understanding of analytical techniques such as flow cytometry, PCR, etc. that are core to cell therapy product quality is required.
• Track Record: Proven success in developing and transferring processes to external CDMOs and supporting successful regulatory filings (IND/BLA/MAA) including resolving root cause investigations.
• Communication: Exceptional verbal and written communication skills, with the ability to translate complex process development data and decisions into strategic insights for senior leadership.

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! 

*THIS POSITION WILL COVER THE CENTRAL GREAT PLAINS REGION: Texas, Nebraska, Oklahoma, Colorado, North Dakota, South Dakota, New Mexico, and Iowa.

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%

SUMMARY

As a member of the Sales and Qualified Treatment Center (QTC) Account Team, you will work alongside a team of committed members driven to make a profound impact on people living with rare diseases through our mission of establishing gene therapy as a meaningful option for patients.

The Account Manager, gene Therapy will have primary accountability for managing their business within their territory and driving the utilization of Genetix’s approved gene therapies within their QTC accounts. The QTAL will achieve these goals through the development and execution of strategic account plans, dynamic collaboration with internal and external stakeholders, identifying key drivers for business performance, and educating HCPs and other key account stakeholders about Genetix’s gene therapy to drive the identification of appropriate patients.

This is a FIELD BASED POSITION and will cover the New England Territory.

RESPONSIBILITIES

• Delivering approved education, messages, and tools about Genetix’s gene therapy products to a broad set of QTC (Qualified Treatment Center) stakeholders, including HCPs and other key decision-makers to drive product utilization.
• Building and implementing strategic account plans for assigned QTCs (Qualified Treatment Centers) to advance account business objectives, patient identification, and pull-through of appropriate patients for Genetix’s gene therapies.
• Identifying barriers within the account and collaborating with Genetix cross-functional colleagues, including but not limited to Apheresis Operations, Patient Supply, Patient Educators, Market Access, and Medical Affairs, to deploy solutions to address the account’s needs.
• Engaging with community-based HCPs focused on hemoglobinopathies to educate them on disease state, unmet needs, and Genetix’s gene therapies.
• Serving as the main point of contact for assigned accounts to coordinate the QTC (Qualified Treatment Center) activation process to onboard HCPs, apheresis, cell therapy labs, transplant coordinators, pharmacy, and reimbursement leads within the QTC (Qualified Treatment Center)
• Providing customer insights and feedback to Genetix leadership regarding account business trends, performance, business issues, and opportunities.
• Developing and implementing strategic and measurable business plans to ensure the achievement of account objectives and goals (patient starts, patient pull-through, and QTC activation).
• Maintaining expertise in hemoglobinopathies, including Sickle Cell Disease, Transfusion-dependent Beta-thalassemia, Genetix’s gene therapy products, and the gene therapy treatment process.

QUALIFICATIONS

• Bachelor’s degree required with 10+ years of experience in the healthcare industry and a high-performance track record, preferably in sales and commercially focused roles (Sales, Operations, Account Management, etc.).
• Direct line leadership experience preferred.
• Successful track record within hospital inpatient and outpatient settings, including the development of KOL relationships.
• Demonstrated experience in specialty therapeutic areas such as Hematology, CAR T, or Cell and Gene Therapy.
• Strong account management experience within hospitals, IDNs, ACOs, and/or organized customers; strong clinical selling experience is a must (high level of clinical and selling acumen).
• Entrepreneurial spirit and strong problem-solving skills for business management of territory.
• Strong communication and relationship-building skills, applying a consultative approach to establish and sustain a strong network with a wide range of stakeholders.
• Proficient with MS Office (including Word, Excel, and PowerPoint), Field Force Effectiveness tools (e.g., Veeva), and administrative tools (e.g., Concur).
• Travel up to 50-75% for face-to-face customer meetings and national company meetings.