Associate Director, Clinical Operations Lead, Study Start-up & Feasibility

This is a highly cross-functional position, requiring collaboration with internal teams, CROs, and vendors. The candidate must be comfortable working directly with clinical trial sites.

The contribution of the candidate directly supports the goals of the Development Operations organization under R&D.

This is a great opportunity for an individual with an operational background and innovative mindset to help us accelerate study execution to support Sarepta’s goal of Patient’s First.

More about You

Primary Responsibilities Include:

• Develop and implement feasibility and start-up strategies to support the success of Sarepta’s clinical studies.
• Oversee study feasibility activities, including country, site, and investigator selection for participation in Sarepta clinical studies.
• Gather cross-functional, country-level input to inform robust feasibility strategies.
• Develop and manage integrated feasibility and site start-up timelines, and report on progress, including plans to address potential timing risks or gaps.
• Establish study-specific meetings to review clinical trial feasibility data and start-up activities with study leads, MSLs, and the CRO; report metrics to broader teams, including senior management.
• Lead calls with Sarepta and CRO partners to manage feasibility and study start-up activities and ensure study timelines are achieved.
• Foster a culture of innovation by developing new ideas and programs to advance feasibility and support departmental growth.
• Provide guidance and mentorship to junior members of the Study Start-up and Feasibility team.
• Create reporting tools to measure ongoing activities, as well as key performance, quality, and effectiveness indicators.
• Partner with Clinical Operations, CRO teams, and other key stakeholders to implement innovative feasibility initiatives, including data collection within CTMS.
• Support and/or lead the development of charters and SOPs related to Study Start-up and Feasibility.
• May have direct reports.

Desired Education and Skills:

• BA/BS degree in a related field; 10+ years related experience in the pharmaceutical or biotech industry within a clinical operations or project management role or similar
• Experience in clinical study budget planning, and program implementation
• Experience with both direct line management and dotted line reporting
• Experience in developing feasibility questionnaires
• Experience with protocol and ICF development and review
• Experience in clinical study start-up
• Experience with rare disease / difficult to recruit populations a plus
• Experience identifying and managing multiple CROs, vendors, budgets, KPIs.
• Comprehensive regulatory knowledge, including ICH and GCPs
• Exceptional organizational skills and ability to deal with competing priorities
• Strong analytical reasoning and problem-solving ability
• Excellent PowerPoint slide development and presentation skills
• Ability to multi-task, work independently and as part of a multidisciplinary team, exercise sound judgement and escalate issues when necessary

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

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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 $160,800 - $201,000 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.