Senior Manager, Real World Evidence (RWE) Operations

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness

• Financial Wellness

• Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role

The Opportunity to Make a Difference

• Project management of internal and external research initiatives
• Manage day-to-day activities for multiple Phase IV studies focused on Real World Evidence collection in patients receiving commercially approved products.
• Coordinate and execute activities related to registry and Phase IV study operations, ensuring timelines, budget, and quality standards are maintained.
• Serve as the liaison with external collaborators, providing high-level customer service.
• Schedule and facilitate discussions with cross-functional internal teams and external investigators.
• Coordinate activities with internal stakeholders including Clinical Operations, Biometrics, Regulatory Affairs, and Patient Advocacy.
• Maintain and update RWE budget trackers, managing agreement execution and purchase order development.
• Ensure timely tracking of study-related activities and overall project milestones.
• Maintain RWE SharePoint and Webpage to ensure documentation is up to date and accessible.

• Work with vendors on monthly project accruals and accurate forecasting in collaboration with project leads.

Research Support:

• Support product and team leads with primary and secondary data research activities.
• Assist in the development, implementation, and interpretation of Phase IV studies, ensuring adherence to study timelines.
• Collaborate with cross-functional teams to prepare documentation for regulatory submissions, reimbursement agencies, and other external organizations.
• Maintain knowledge of evolving epidemiological methods, tools, and data sources.

More about You

• Bachelor's Degree in a life science discipline preferred; Master's Degree in Sciences, Public Health, Epidemiology, Biostatistics, or related field preferred.
• Minimum of 5 years of organizational experience in the biotech/pharmaceutical industry.
• Experience in collaboration with clinical operations and vendors for clinical/phase 4 studies
• Experience with Phase IV studies and research procedures such as clinical operations IRB submissions.
• Strong ability to multi-task, manage multiple projects, and work in fast-paced cross-functional teams.
• Previous project management experience with proven ability to identify issues, provide solutions, and ensure project timelines are met.
• Excellent organizational, interpersonal, and communication skills (verbal and written) with exceptional attention to detail.
• Strong proficiency in Microsoft Word, Excel, and PowerPoint.
• Strong proficiency in medical writing

Preferred Experience:

• Background in rare disease research and/or muscular dystrophy studies is a plus.
• Experience in managing study risk plans, problem-solving, and creative thinking within analytic and data-focused tasks.

Travel Requirement:

• This role is expected to travel less than 25% of the time.

What Now?

We're always looking for solution-oriented, critical thinkers.

So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.