The Sr Center of Excellence Medical Specialist will support the in-house Medical Affairs team in the development and execution of tactical and outreach plans to future treatment centers (Centers of Excellence – COEs) related to the potential launch of the first gene therapy product for an ocular disease in the United States.
She/he will be responsible for the day-to-day interaction and ongoing communication with COEs as well as vendors involved with COE post-launch activities. She/he will drive the tactical execution and implementation of the COE training program, and will continue to provide constant structured support to COE physicians and pharmacy personnel, to ensure flawless use of the product.
She/he will play a proactive and collaborative role, working in close partnership with a cross functional team, including Patient Services, Commercial, Market Access, Regulatory, Safety and Pharmacy teams, disseminating information, issues and timelines specific to Medical Affairs’ activities.
She/he will also have the opportunity to support in-house Medical Affairs team within a broader scope as needed, including development of scientific material, planning and execution of advisory boards, symposia, and presentations at medical meetings to ensure compliance and adherence to the company policy. She/he shall be able to deliver medical information for internal personnel and external customers.
80% of the time
- Build and establish relationships with launch COEs’ key stakeholders.
- Complete a comprehensive assessment of COE activities related to patient episode of care and overall institution capacity.
- Develop COE implementation tactical plan and ensure execution of activities in timely fashion.
- Responsible for development and update of medical/scientific materials for COE training program, encompassing surgical and pharmacy training.
- Responsible for project management and logistics of COE training program including workshops, managing Medical Affairs’ relationships with third parties (agencies/vendors/contract research organizations).
- Work closely with COE staff to evaluate institution’s needs and provide aligned and structured support on ongoing basis, ensuring quality control.
- Responsible for overseeing dry runs and simulation activities with COE personnel prior to treatment initiation to ensure institutional ability to handle drug and delivery.
- Support the development of database of COE output performance, and lead critical data analysis, including safety data.
- Represent Medical Affairs in meetings with internal cross-functional team and external stakeholders related to COE activities.
- Prospect and evaluate new potential COEs based on objective criteria.
15% of the time
- Support planning and execution of advisory boards, symposia, and presentations at medical meetings to ensure compliance and adherence to the company policy.
- Support data analysis and the development of scientific material
- Deliver medical information for internal personnel and external customers
5% of the time
- Other duties and projects as assigned by manager.