Associate Director, Clinical Operations Lead, Study Start-up & Feasibility
Sarepta Therapeutics
14 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Primary Responsibilities:
- Develop and implement feasibility and study start-up strategies for Sarepta clinical studies.
- Oversee feasibility activities, including country, site, and investigator selection.
- Gather cross-functional, country-level input to inform feasibility strategies.
- Develop and manage integrated feasibility and site start-up timelines; report progress and timing risks/gaps.
- Establish study-specific meetings with study leads, MSLs, and CRO; report metrics to broader teams/senior management.
- Lead calls with Sarepta and CRO partners to manage feasibility/start-up and ensure timelines.
- Foster innovation; develop new ideas/programs to advance feasibility.
- Mentor junior team members; may have direct reports.
- Create reporting tools/indicators (performance, quality, effectiveness).
- Partner with Clinical Operations and CRO teams; implement feasibility initiatives including CTMS data collection.
- Support/lead charters and SOPs related to Study Start-up and Feasibility.
Desired Education & Skills:
- BA/BS + 10+ years in pharma/biotech clinical operations or project management.
- Clinical study budget planning and program implementation.
- Experience with direct line management and dotted line reporting.
- Feasibility questionnaire development; protocol and ICF development/review; clinical study start-up.
- Experience with rare disease/difficult-to-recruit populations (plus).
- Manage CROs/vendors/budgets/KPIs.
- Regulatory knowledge (ICH, GCP).
- Strong organization, analytics/problem-solving, PowerPoint/presentation; ability to multi-task and work cross-functionally.
Hybrid (on-site at U.S. facilities and occasional in-person events). Candidates must be authorized to work in the U.S. Salary range: $160,800–$201,000/year. Encouraged to apply if solution-oriented and comfortable with ambiguity/candor.
- Develop and implement feasibility and study start-up strategies for Sarepta clinical studies.
- Oversee feasibility activities, including country, site, and investigator selection.
- Gather cross-functional, country-level input to inform feasibility strategies.
- Develop and manage integrated feasibility and site start-up timelines; report progress and timing risks/gaps.
- Establish study-specific meetings with study leads, MSLs, and CRO; report metrics to broader teams/senior management.
- Lead calls with Sarepta and CRO partners to manage feasibility/start-up and ensure timelines.
- Foster innovation; develop new ideas/programs to advance feasibility.
- Mentor junior team members; may have direct reports.
- Create reporting tools/indicators (performance, quality, effectiveness).
- Partner with Clinical Operations and CRO teams; implement feasibility initiatives including CTMS data collection.
- Support/lead charters and SOPs related to Study Start-up and Feasibility.
Desired Education & Skills:
- BA/BS + 10+ years in pharma/biotech clinical operations or project management.
- Clinical study budget planning and program implementation.
- Experience with direct line management and dotted line reporting.
- Feasibility questionnaire development; protocol and ICF development/review; clinical study start-up.
- Experience with rare disease/difficult-to-recruit populations (plus).
- Manage CROs/vendors/budgets/KPIs.
- Regulatory knowledge (ICH, GCP).
- Strong organization, analytics/problem-solving, PowerPoint/presentation; ability to multi-task and work cross-functionally.
Hybrid (on-site at U.S. facilities and occasional in-person events). Candidates must be authorized to work in the U.S. Salary range: $160,800–$201,000/year. Encouraged to apply if solution-oriented and comfortable with ambiguity/candor.