Scientific Director - Abeona : Job Details

About Abeona

Abeona Therapeutics Inc. (ABEO) is a clinical-stage biopharmaceutical company developing cell & gene therapies for serious and life-threatening diseases. We recently announced plans to submit a Biologics License Application (BLA) to the US FDA for our lead investigational therapy EB-101 and anticipate US approval next year. EB-101 is a genetically engineered, autologous cell therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB).

RDEB is a rare, inherited connective tissue disease in which both copies of collagen-producing genes (Col7A1) are mutated. In the absence of collagen protein, skin becomes fragile and even the slightest shear can result in severe blistering and formation of wounds that are often painful, large, and chronic. Patients live a debilitating life often wrapped in bandages to minimize the risk of infections, carcinomas, and an untimely death. Pz-cel is a breakthrough therapy that has demonstrated remarkable results in pivotal Phase 3 studies. Based on the high unmet need, strong clinical profile of Pz-cel, and the significant commercial opportunity, Abeona has decided to build a nimble commercial organization to launch Pz-cel following its potential approval in the U.S. next year.

Abeona is looking for a seasoned Scientific Director to join our team. The Scientific Director is a pivotal role within our organization, responsible for providing strategic scientific leadership and driving the advancement of Pz-cel.

• Provide specialized medical and scientific input into core medical affairs activities, including:
• Healthcare professional and payer interactions.
• Generation of clinical and scientific data to enhance therapeutic benefit and value.
• Educational initiatives, including medical education and value propositions.
• Safeguarding patient safety through risk minimization and safety surveillance activities.
• Onboarding and training COEs: assist in onboarding and training Centers of Excellence (COEs) to use Pz-cel in a commercial setting.
• Site qualification: collaborate in the qualification of clinical sites for the use of Pz-cel in a commercial setting.
• Medical education development: work with the Executive Medical Director to finalize the development of the medical education program.
• Medical education for COEs: implement medical education programs for COEs to support the use of Pz-cel in commercial settings.
• Medical inquiries: collaborate with the Executive Medical Director to address medical and off-label inquiries.
• Adverse event assessment: work with the Executive Medical Director to assess serious adverse events (S/AEs).
• Medical monitoring and reporting: assist in medical monitoring for ongoing studies and post-approval S/AE reporting.
• Regulatory: support communication with the FDA during regulatory processes.
• Conference engagement: promote Abeona's assets by creating awareness at scientific conferences.
• KOL relationships: engage and foster relationships with Key Opinion Leaders (KOLs) at COEs and Qualified Treatment Centers (QTCs).
• Data generation and publication: lead data generation initiatives to address open data questions and support publication efforts.
• HEOR projects: lead and manage Health Economics and Outcomes Research (HEOR) projects to support commercial strategy and demonstrate Pz-cel's value.
• Payer negotiations: participate in payer negotiations to ensure alignment between scientific and commercial goals.
• Launch support: in the initial stages of Pz-cel's launch, there may be increased travel requirements, including assisting in the operating room during procedures and performing quality control on the final product.
• Post-launch focus: following Pz-cel's launch, the role may focus primarily on Pz-cel or other clinical development assets, depending on Abeona's evolving business needs.

• Education: Advanced scientific degree (NP, PhD, MD/DO or PharmD) required.
• Clinical trials and clinical development experience in the pharmaceutical industry or academia or equivalent setting required.
• Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials.
• Experience in development strategy and protocol design.
• Clinical development experience required; medical affairs experience preferred.
• Excellent oral and written communication skills.
• Ability to interact effectively with internal and external stakeholders.
• Knowledge of cell & gene therapy is essential.
• Ability to travel at least 30%.