Director, External Data

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

This individual is an experienced clinical data management leader and reports to the Head of the External Data team within the Clinical Data Management function. This role is accountable to oversee and lead all activities associated with the collection, transfer, and quality of clinical trial data collected from external sources (i.e., central labs, specialty data providers, eCOA, IRT, etc.) across the clinical data management function. This individual provides both subject matter and technical expertise in clinical data management and supports multiple therapeutic area teams as an external data specialist.

The Opportunity to Make a Difference

• Accountable to support all Data Management timelines and quality of external data deliverables in collaboration with the study Data Management leads other development functions
• Measures vendor success through mutually agreed key performance indicators (KPIs) and service level agreements (SLAs)
• Manage the standards, data transfer specifications, and data flow for collection and on-going review of external clinical trial data
• Develop process automation tools and processes to enable real-time data flow from external vendor partners
• Provide subject matter expertise and external data leadership to the clinical trial data repository development team
• Provide technical and process leadership for external data to cross-functional teams
• Collaborate with the Early Research and Gene Therapy Center of Excellence teams to streamline data flow and data review requirements
• Manage external data vendors to meet regulatory requirements, quality standards, timelines and budget constraints. May participate in external data vendor selection activities
• Partner with study Lead DMs and Clinical Trial Teams (CTTs) in the on-going external data updates, data reconciliations between EDC and external sources, and on-going data cleaning to enable high-quality data snapshots and soft locks to support various trial and/or program activities 
• Provide external data leadership and support for key database lock activities to ensure high quality data with proper documentation and inspection readiness
• Collaborate with Clinical Operations Excellence team members in implementing cross-functional platform solutions to support all aspects of data collection and reporting
• Ensure close collaboration of Data Management with other functions in various activities to achieve program and trial level goals
• Develop and oversee new or revised external data vendor KPIs and metrics to inform cross-functional teams and support vendor oversight

More about You

• Bachelor's degree or higher, preferably in a data science or health related discipline
• 8+ years of clinical data management experience in pharma/biotech industry, with previous external data oversight experience expected
• Previous experience and leadership in managing external data providers for Data Management (i.e., central labs, specialty vendors, IRT, etc.)
• Previous experience and leadership with Electronic Patient Reported Outcomes (ePRO) and Electronic Clinical Outcomes Assessments (eCOA) is preferred
• Strong expertise in clinical data management for Phases I-IV clinical trials and complex study designs in pharma/biotech industry
• Strong technical skills in database design, data transfer requirements, and data flow
• Can translate highly technical concepts and requirements to cross-functional stakeholders
• Previous experience in leading machine learning, AI, and robotic process automation (RPA) projects in clinical development is helpful
• Experience in managing an outsourced data management model
• Familiarity with GCP, ICH, and FDA and other health authority regulatory requirements as applicable for clinical data management
• Familiarity with CDISC model and associated CDASH and SDTM standards
• Experience in leading Data Management for a BLA or NDA
• Excellent written and oral communication skills
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment

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. Apply