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 Associate Director, Clinical Operations Lead for Immunoassay (IA), Clinical Operations is responsible for the planning, implementation, conduct, and oversight of clinical operations for assigned companion diagnostic studies. This individual is expected to provide leadership as well as line management within Clinical Operations and guidance with regards to operational deliverables. The AD, COL for IA may be responsible for project oversight across IA studies within a program.

The Opportunity to Make a Difference

• Serve as the subject matter expert within clinical operations for the planning and execution of IA studies across all phases
• May provide project oversight to IA studies on a large program 
• Oversee Clinical Research Organizations (CROs), vendors and consultants involved with the IA clinical trials
• Serves as the point of contact for protocol execution 
• May participate in the Clinical Trial Team (CTT) and/or the program Clinical Sub Team
• May support the Clinical Operations Program Lead (COPL) to operationalize and execute the Clinical Development Plan (CDP)
• Oversee junior team members and ensure alignment with any supporting COLs assigned to studies
• Establishes the IA study timelines in line with the therapeutic study timelines and the company goals and ensures accurate tracking and reporting of IA study metrics and progress through completion of study dashboards
• Works cross-functionally to ensure clinical program timelines and goals are met and risks are appropriately escalated to the Clinical Operations Program Lead (COPL)
• Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
• Develops, reviews and/or consults on reports and clinical trial documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates
•  Responsible for communication and escalation of IA study related issues to the COPL
• Provides enrollment forecasting to the COPL in alignment with the therapeutic study
• Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed, or delegates activity with oversight
• Participates in and responds to Quality Assurance and/or regulatory authority inspection audits 
• In conjunction with CRO and appropriate internal stakeholders, facilitates the development of trial budgets and execution of clinical trial agreements and other relevant documents
• Manages the clinical trial budget and provides financial reporting and projections to Finance  
• Leads creation of scope of work and budgets and escalates vendor performance issues to COPL and Procurement as necessary 
• May serve as an escalation point for more clinical operations team study team members internally and with vendors 
• Assume leadership role in operational improvement initiatives (e.g., SOP development, training etc.)

Up to ~4 direct reports consisting of CTAs, COLs, Sr. COLs

More about You

• Experience managing a clinical study with a Companion Diagnostic (CDx) and/or in vitro diagnostic (IVD)
• Experience in management of CROs, vendors and consultants
• Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICH guidelines for patient registries and studies
• Experience developing IVD trial plans including informed consent, site management, risk mitigation strategies, trial budgets and program-level budgets
• Proficient written and verbal communication skills
• Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation 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 7+ years’ experience in clinical research with at least 5 years’ experience in study management with strong experience with CDx and/or IVD studies, study phases I-IV, global trials, and with complex trial designs
• Program-level experience preferred.
• Rare disease experience preferred.
• Line management experience preferred

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-TD1This 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 $156,000 - $195,000 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.