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.
RESPONSIBILITIES: 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.
Highly organized and demonstrates consistent attention to detail
Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
High ethical standards
Must demonstrate accountability for delivery of results and have good problem-solving and decision making skills.
Excellent oral and written communication skills
Excellent diplomatic skills with the ability to manage differing opinions and perspectives, and experience in building strong and effective third party partnerships
Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines
Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
Must have the ability to operate in fast-paced, timeline-oriented, team environments/matrix organizations
Must possess the ability to work independently, be flexible and have strong organizational skills.
Minimum 5+ years experierience in biotech/pharma/CRO with related experience in clinical operations, clinical research or medical affairs.
Experience as a clinical trial specialist, site monitor, clinical research associate or medical affairs associate preferred.
Knowledge of ophthalmology strongly preferred
Must have demonstrated project management skills
Proven ability to critically evaluate and summarize clinical and scientific data
The successful individual will be empowering and a self-starter, pragmatic, capable of working independently.
She/he will need to have excellent communication, diplomatic skills, and is expected to foster teamwork and collaboration.
Additional Salary Information: Our employees enjoy a variety of benefits:
Employee stock purchase plan
Two medical plan options; dental and vision
401(k) retirement savings plan
Paid time off to recharge
Basic life, voluntary life and AD&D
Short-term and long-term disability
Dependent care FSA
Employee assistance program (EAP)
Health advocate service
Parking and transit
Fruit and snacks in the kitchen
Open spaces for grabbing lunch, coffee or just catching up!
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic... diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.