Director, COPL Early Research

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

The Director, Clinical Operations Program Lead, Early Phase will function in a strategic leadership role accountable for overseeing and executing high quality early phase studies and programs on time and within budget, including providing Clinical Operations support and expertise to the cross-functional team, when applicable. This is a collaborative role in a cross-functional and matrixed environment. The Early Phase COPL also assumes a leadership role across Clinical Operations which includes recruiting and maintaining a high-quality team and serving as a subject matter expert on functional initiatives.

More about You

• Contributes to the development of Clinical Development Plans (CDPs) including scenario planning, high-level forecasting of timelines, assesses program level feasibility, estimation and allocation of resources and budget, and development of high-level operational strategies
• Provides strategic oversight and input into the design of the clinical program and plays a key role in the work required to determine possible program design options
• Accountable for meeting all operational deliverables in accordance with the timeline, cost, and quality commitments
• Maintains an overview of status, issues, and proactively communicates progress, issues or changes that may impact timelines and costs of the program to relevant stakeholders
• Ensures internal consistency across studies within a program and ensures alignment of operational program to the development team goals
• May serve as the Clinical Sub Team member at the Global Program Team (GPT) meetings to ensure delivery of the Clinical Development Plan (CDP) to meet strategic objectives of the program/platform plan
• May collaborate with the Site Start-up and Feasibility group to assess county and site engagement to facilitate the development of early phase timelines and optimize clinical program delivery
• Partners with key internal and external stakeholders to provide oversight and leadership that supports the design and execution of development programs that enable proof of concept
• Provides program leadership and trial subject matter expertise to the clinical trial teams
• Mentors and coaches Clinical Operations program team (direct and dotted-line reports), provides timely feedback to Clinical Operations Department Head regarding staffing needs and individual performance feedback
• Provides performance, talent and resource management, and succession planning
• Identifies, recruits, hires, and develops Clinical Operations staff, as well as oversees their work to ensure all department goals, deliverables, and objectives are met
• Ensures that employees are appropriately trained and comply with company and regulatory standards
• Creates a positive work environment by encouraging mutual respect, creativity, and accountability
• Serves as an escalation point for the study teams internally and with vendors
• Actively participates in vendor/external partnership governance
• Participate in and/or lead working groups and/or initiatives within the Clinical Operations organization or cross functionally (at least 10% allocation to non-program specific work)
• Up to ~6 direct reports consisting of Clinical Trials Associates (CTAs) Clinical Operations Leads (COLs), and Associate Director, Clinical Operations Leads (AD COLs)

Desired Education and Skills:

• Minimum of 8+ years of experience in Clinical Operations with direct experience in management and oversight of early phase studies.
• Experience in planning, management, and oversight of early phase clinical trials and programs.
• Experience with managing and demonstrating oversight of CROs, vendors, and consultants
• Strong experience with both direct line management and dotted line reporting
• Extensive knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials
• Prior regulatory inspection experience preferred
• Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills
• Proficient written and verbal communication skills
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook, and MS Project
• Position may require some travel
• Bachelor's degree in health sciences or related field
• Line management experience required

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.