Associate Director, Clinical Operations Lead, Study Start-up & Feasibility
$160,800–$201,000 year
Hybrid · Cambridge, Massachusetts, United States
Job Summary
Associate Director, Clinical Operations Program Lead, Study Start-up & Feasibility role leading feasibility and start-up strategy across Sarepta’s clinical programs. Responsible for directing feasibility activities, country/site feasibility, overseeing timelines/goals for clinical studies, developing feasibility plans, coordinating with CROs/vendors, and mentoring junior team members. Requires robust clinical operations expertise, experience in feasibility, study start-up, budget planning, vendor management, regulatory knowledge (ICH/GCP), and strong leadership in a cross-functional environment. Hybrid role on site at Sarepta facilities in the United States with periodic in-person events; targeted salary range $160,800 - $201,000 per year.
Required Qualifications
- 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
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