Director, Clinical Operations Excellence

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

• Lead select vendor governances
• Drive and manage ongoing maintenance of Clinical Trial Operating Model (CTOM) as CTOM task force lead
• Serves as the subject matter expert and primary point for Development Operations SOPs, process oversight, and good clinical practice (GCP)
• Drives gap analysis and reconciliation of Dev ops-owned SOPs; and management of SOPs per Sarepta guidelines; support of CRO SOP gap analysis
• Drive Clinical Operations Excellence by managing Oversight activities for cross-program monitoring oversight program
• Drives certain JOC meetings and provides ongoing clinical operations oversight and support on resolution of issues
• Supports compliance activities including SOP activity and training compliance; support teams with risk management/mitigation in accordance with the requirements of ICHE6(R3)
• Manages inspection preparation activities as required
• Supports process build of clinical development process and business area SOPs as fit for purpose and in compliance with regulatory requirements; confirm SOPs are an accurate representation of the way work is executed
• Provides input and support for training sessions on best practices, trends, regulatory requirements guidance, and GCP topics to facilitate continuous improvement in quality and on-going adherence to standards and regulations
• Assists with the creation and delivery of tools, templates, training, and guidance for best practice and reporting and minimizing risk while ensuring quality is integrated into our processes
• Drives process change within Development Operations related to day-to-day processes, SOP activity, risk management/mitigation
• Assists other functional groups, as needed, on time-sensitive materials relating to Quality Issues and Events
• Drives overall Clinical Vaults, including CTMS, implementation and maintenance and be a change agent for the system within Sarepta to ensure adoption of new capabilities and business process
• Be a point-of-contact for CTMS to ensure established milestones are met
• Partner with appropriate functional stakeholders, technology vendors, and CRO partners to avoid and resolve risks and issues within the CTMS and other Clinical Vaults, as applicable
• Participate in preparing functions for submission readiness as it relates to Clinical Vaults and may represent Dev ops group in a formal inspection or audit
• Liaise with internal R&D Business Operations and R&D Quality and Compliance to execute best practice relationship infrastructures, and efficient, high quality & compliant business processes
• Assume leadership role in operational improvement initiatives
• May support additional ad-hoc activities as agreed with the Executive Director, Operational Excellence

More about You

• Bachelor's Degree is required. An advanced degree is highly preferred.
• 7+ years of experience gained with a CRO, biotech, or pharmaceutical company
• 5+ years of clinical research in a GCP Function
• Experienced in supporting clinical trial GCP compliance/quality management activities
• Line management experience required
• Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timely
• Ability to work independently and manage deadlines
• Problem-solving, process improvement, analytical, and collaborative skills
• Excellent oral, written, presentation and cooperation skills
• Self-motivated, calm under pressure and adaptable to a dynamic environment with the ability to support successful change
• Experience with corrective/preventive actions and effectiveness checks
• Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICH guidelines for patient registries and studies
• Experience developing trial plans including site management, risk mitigation strategies, trial budgets and program-level budgets
• Ability to collaborate effectively with study teams, cross-functional team members and external partners using collaborative negotiation skills
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project
• Position may require some travel

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.