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 Associate Director, Clinical Systems, Clinical Operational Excellence is responsible for managing the day-to-day operations of important clinical systems (i.e. Clinical Trial Management System, Trial Master File, etc.) that support clinical trial execution and management. The individual participates in and leads transformative initiatives that create effective and efficient processes that meet high compliance standards, collaborating across Development Operations, Information Technology, key stakeholders, and external vendors.
The Opportunity to Make a Difference
- Lead and participate in transformative initiatives that create effective and efficient processes that meet high compliance standards, collaborating across Development Operations
- Collaborate with team members to reinforce and operationalize strategic direction and solutions that support the ability to deliver on commitments to the organization and to patients
- Oversee building capabilities, implementation and maintenance of CTMS and TMF systems, and related applications, in support of related processes
- Lead the creation and delivery of system related training
- Ensure system administrative and study-related set-up activities are defined, appropriate and carried out in a timely manner
- Oversee system user access management
- Collaborate with system and technology team to support data aggregation and reporting
- Lead an ongoing community of practice and functional superusers for CTMS
- Ensure the system and associated activities are managed within budget/resource/timelines
- Actively support the strategic vision for CTMS and TMF to maximize end user focus and engagement, internal and external end users
- Partner with key internal and external stakeholders to remediate risks and manage emerging issues
- Use proactive approaches to process improvements and enhancements of CTMS and TMF capabilities and standards
- Partner with appropriate stakeholders in DM, PMBA and R&CD QA (and others as applicable) on technology standards and governance models
- Lead and manage system related change control activities
- Foster best practices, mentor and consult on CTMS and TMF across the Development and Operations organizations
- Keep current on changes in industry and regulatory standards for GCP requirements and advises on business impact for CTMS and TMF
- Provide expert support for CTMS and TMF audits and inspections
- Promote a culture of continuous improvement; acts as a change champion and effectively leads change
- Core member of the Sarepta Cross Vault Governance Center of Excellence and other related Governance committees
- May support additional ad-hoc activities as agreed upon with Director, Clinical Operations Excellence
- Works on issues where analysis of situations or data requires an in-depth knowledge of Clinical systems
- Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
- Establishes and assures adherence to budgets, schedules, work plans, and performance requirements
- Any mistake would have immediate impact to the Operational Excellence team
- Any mistakes may have larger impacts to cross functional teams
- The incumbent would be interacting with the team, Director level, and cross functional teams regularly, including external vendors
- Works to facilitate individual and sub-team goal setting with direct reports, as applicable
More about You
- Expert knowledge of Clinical Systems – CTMS, TMF, etc.
- Experience and knowledge of planning implementations, liaising with IT and QA for change controls/upgrades
- Able to effectively communicate on clinical operations topics both internally and externally
- Able to implement directives, meet deliverable timelines, exercise managerial discretion, advanced analytical/forward thinking and prioritization skills, and escalates when necessary
- Able to maintain a high level of quality, accuracy, and attention to detail in a fast-paced environment with shifting priorities
- Must be proactive, self-motivated, excel at relationship building, and able to work independently with minimal supervision
- Must have strong work ethic, excellent organizational skills, strong oral and written communication skills, have a ‘can do’ approach, strong problem-solving skills, and be a team player
- Extensive knowledge and application of ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization E6(R2) guidelines
- Must have ability to manage and navigate multiple electronic Clinical systems and advanced proficiency in Word, Excel, and PowerPoint
- BS/BA degree or equivalent required with 10+ years of related experience
- Prior clinical research experience including relevant clinical systems
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 $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.
