Executive Director, Clinical Operations

Sarepta Therapeutics
United States, Massachusetts, Cambridge
215 First Street (Show on map)
Feb 19, 2025
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 Executive Director, Clinical Operations Therapeutic Area (TA) Lead will function in a strategic leadership role accountable for managing all assets and clinical programs within assigned TA. The TA Lead is responsible for driving program teams within the TA towards corporate and asset goals. The TA Lead is expected to be a seasoned leader that can provide technical expertise and inspire and motivate their teams. This is a highly visible role within Development Operations and R&D. The TA Lead will assume a functional leadership role involving hiring and headcount planning and envisioning and driving departmental and cross-functional initiatives. The Opportunity to Make a Difference Oversee multiple assets and clinical programs within an assigned TA May sit on Global Program Teams as Clinical Sub-team representative and/or co-lead Clinical Sub-teams with Clinical Development Will oversee Clinical Operations Program Lead(s) responsible for assigned clinical programs Contributes to and oversees the development of 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 Accountable for meeting all operational deliverables in accordance with the timeline, cost, and quality commitments Ensures internal consistency across TA and ensures alignment of operational program to the development team goals Interfaces with key internal and external stakeholders (senior leadership, KOL's, advocacy groups, external partner leadership teams, etc.) Provides functional leadership and clinical trial subject matter expertise to the program and clinical operations teams Mentors and coaches clinical operations TA team (direct and dotted-line reports), provides timely feedback to Head of Development Operations regarding staffing needs and individual performance feedback Provides performance, talent and resource management, and succession planning Identifies, recruits, hires, and develops 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 Actively participates in vendor/external partnership governance Participate in and/or lead working groups and/or initiatives within the Development Operations organization or cross functionally (at least 25% allocation to non-program specific work) Up to ~6 direct reports of any level More about You 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 Experience developing and implementing program-level plans including reporting tools, timelines, budgets 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; travel to the office is expected for critical activities Bachelor's degree in health sciences or related field Minimum of 12+ years of experience in clinical research with at least 8 years of experience directing and implementing clinical program strategy 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. #LI-Hybrid #LI-PM1 This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $248,000 - $310,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.