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:
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
The Director, Clinical Operations Program Lead, Real World Evidence (RWE) will function in a strategic leadership role accountable for managing the overall execution of the RWE studies operationalized within R&D. They will develop and recommend operational strategies and/or decisions in support of achieving clinical program objectives. The 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.
The Opportunity to Make a Difference
- 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
- Build out the RWE model as the Sarepta pipeline continues to grow.
- Lead growth through cross collaboration with stakeholders from the customer organization (RWE, outcomes, commercial, etc.)
- 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 RWE studies and ensures alignment of operational programs to the development team goals
- May be a member of the Clinical Sub Team (CST) and/or Global Program Team (GPT)and ensures appropriate strategic topics are discussed and managed
- Interfaces with key internal and external stakeholders (senior leadership, KOL’s, advocacy groups, external partner leadership teams, etc.)
- Provides RWE program leadership and trial subject matter expertise to the clinical trial teams
- Mentors and coaches the RWE team (direct and dotted-line reports), provides timely feedback to the Department Head 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
- 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 Development Operations organization or cross functionally (at least 10% allocation to non-program specific work)
Up to ~6 direct reports consisting of RWE Clinical Trials Associates (CTAs) and RWE Clinical Operations Leads (COLs)
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
- 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
- Minimum of 8+ years of experience in clinical research with at least 2 years of experience directing and implementing clinical program strategy
- Experience with real world evidence studies preferred
- 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-Remote
#LI-TD1
This position is remote. However, 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 $180,000 - $225,000 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.
