Position Summary:

The Director of Scientific Communications & Evidence Generation will be responsible for developing a plan for disseminating the company’s scientific data (manuscripts, abstracts, posters, presentations); as well as identifying clinical evidence gaps, overseeing non-registrational research, and collaborating with cross-functional teams to generate real-world evidence (RWE), health economics and outcomes research (HEOR), and investigator-sponsored research (ISR) to support product value and safety profiles. This role requires strong scientific writing skills, advance understanding of industry best practices related to publication-related and research-related compliance, as well as cross-functional leadership savvy.

Key Responsibilities:

Scientific Communications & Publication Planning

• Develop and maintain and 18-month publication plan and lead the publication review process (abstracts, posters, oral presentations, manuscripts, review articles, etc) in compliance with GPP (Good Publication Practice) and ICMJE authorship criteria, as well as data transparency, and fair balance.
• Utilize innovative formats (micro‑learning, interactive pathways, patient‑friendly visuals) and ensure accessibility for diverse audiences
• Maximize the scientific impact of company data via the strategic selection of journals and congresses
• Collaborate with internal/external expertsand vendors to draft content and ensure the scientific accuracy of all data to be presented.
• Maintain the enterprise scientific lexicon and core claims matrix; ensure consistency across materials and channels.

Data Generation: 

• Lead the development of an integrated evidence generation plan (IEGP) aligned with overall medical affairs goals to address unmet needs in collaboration with Clinical Development, Regulatory, HEOR, and Commercial teams to avoid duplicative efforts. 
• Evaluate and acquire new data sources (clinical trials, RWD, registries) to support evidence plans.
• Create processes for synthesizing feedback from various sources, including field insights and advisory boards and analyze the data to uncover trends and actionable insights to guide scientific communication and strategic decision-making designed to effect change.
• Conceptualize and execute non‑promotional education for multidisciplinary audiences (hematology, BMT/transplant, apheresis, transfusion medicine, genetic counseling, nursing), including webinars, symposia, workshops, and digital learning modules.
• Establish content measurement frameworks (reach, engagement, knowledge lift, practice intent) and continuous improvement loops.
• Provide operational management for Medical Affairs-led research, including RWE, HEOR, and ISR, including monitoring the contractual commitments of vendors and collaborators to ensure quality and timeline adherence.
• Ensure all evidence generation activities follow ICH-GCP guidelines, SOPs, and compliance requirements for post-marketing research.

Cross‑Functional Partnership

• Collaborate within Medical Affairs and with Clinical Development, Regulatory, Pharmacovigilance, Commercial, Market Access, and Patient Advocacy to ensure accuracy and balance across communications.
• Develop and deliver scientific training programs for internal teams (e.g., onboarding for MSLs/field medical; refresher modules on gene therapy mechanisms, safety monitoring, LTFU requirements)..

Associated Responsibilities:

• Own Med Affairs content as well as related SOPs and work processes.
• Ensure adherence to policies and procedures via audits.
• Develop and deliver monthly and quarterly updates to track progress and align on key priorities.
• Develop and manage department budget
• Lead or co‑lead medical review for scientific materials; partner with Legal/Compliance/Regulatory on clear SOPs and guardrails.

Qualifications:

• MD, PharmD, PhD in a biomedical field; experience in hematology or Oncology or cell and gene therapy strongly preferred.
• 8+ years in Medical Affairs/Scientific Communications within biopharma, including publication planning and medical education leadership.
• Understanding of hemoglobinopathies (SCD, β‑thalassemia), cell‑based gene therapy modalities, safety monitoring (including long‑term follow‑up), and registry/RWE experience is preferred
• Experience building omnichannel education programs.
• Fluency with compliance frameworks (GPP, ICMJE, ACCME, OIG, PhRMA Code) and medical review processes.
• Exceptional scientific writing, editorial judgment, and stakeholder management; comfortable engaging with KOLs, investigators, and advocacy leaders.

ABOUT THE ROLE

The Medical Affairs group is driven by our responsibility to patients, our engaging science, and our opportunity to help the scientific community understand what Genetix is working on. Medical Affairs team serves as a trusted and reliable source of information about Genetix’s science to healthcare providers around the world. Through scientific and medical communications, we link the innovative science from our labs and clinical research to the patients in the clinic.

As the only company with three FDA approved gene therapy products, we have accomplished a lot and now we are driven to bring these therapies to a growing number of deserving patients. They have waited a long time for the cutting-edge science to be brought to the clinic, a goal now accomplished by amazing Genetix team. We move with a sense of urgency that reflects our commitment to people suffering from severe genetic diseases and we remember to support each other and have fun doing it!

RESPONSIBILITIES

As a Regional Medical Director Gene Therapy, you would be an integral part of Medical Affairs and will develop and implement the medical strategy for a gene therapy portfolio, ensuring alignment across various internal and external functions.

• Develop and execute Medical Affairs strategy: This includes contributing to the comprehensive strategy for gene therapy across sickle cell disease (SCD) and transfusion dependent thalassemia (TDT) ensuring alignment with the overall company strategy and develop medical plans with company’s goals and milestones. 
• Build external relationships: Develop external relationships to provide scientific and clinical information on our therapies to key HCP and bring actionable insights from the KOL and treating physicians. Scientific exchange is a key element of this role.
• Provide medical leadership to Genetix’s cross-functional teams: Offer medical expertise and input to other teams including commercial, clinical, operations, payor, and advocacy, ensuring a strong and consistent medical voice is represented. 
• Contribute to medical education and communications: Develop and support the creation of medical education materials, scientific communications, and publications. 
• Researching and exploring scientific presentations and publications: Collect the latest data from publications and presentations, gather competitive intelligence in the relevant areas of activity, and summarize key findings for the internal team.
• Ensure compliance: Maintain compliance with applicable company policies and regulations. Ensure that activities including the management, generation, and dissemination of clinical and non-clinical data are conducted with integrity and scientific accuracy. 

QUALIFICATIONS

• Medical degree (MD or equivalent) degree, or advanced scientific or clinical training (for example, Ph.D., PharmD or MSN) with at least 5 years of previous combined experience in relevant patient care and/or Medical Affairs.
• Ability to build and maintain relationships with key opinion leaders and other external stakeholders. 
• Previous experience in Hematopoietic Stem Cell Transplantation, Cell and Gene Therapy or other biologic therapies is required; experience with hemoglobinopathies such as TDT and SCD are also valued.
• Strong scientific expertise and the ability to explain complex concepts clearly is required.
• Residence in Texas, Southern California or Northeast US preferred.
• Must have the ability to travel frequently to the treatment centers, referring practices, academic conferences and other engagements.
• Excellent communication, presentation, and interpersonal skills. Ability to lead technical and business discussions internally and externally.