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Company

Sarepta Therapeutics · 2 hours ago

Director, Study Start-Up

Cambridge, MA

Full-time

Remote

Director/Executive

$180K/yr - $225K/yr

10+ years exp

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BiotechnologyGenetics

Growth Opportunities

No H1B

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Responsibilities

Direct and oversee the feasibility process for Sarepta clinical trials.

Direct and oversee the study start-up activities for Sarepta clinical trials.

Direct and monitor vendors including the creation of vendor governance charter that details roles, responsibilities, KPIs, and deliverables.

Establish study specific meeting series to review clinical trial feasibility data and start-up activities with study leads, MSLs, and the CRO. Candidate will report metrics to larger teams including senior management.

Develop and implement feasibility and start-up to support new clinical studies.

Lead calls with Sarepta and the CRO to manage feasibility and study start-up activities and ensure the study timelines are achieved.

Oversee study feasibility activities including country, site, and investigator selection for participation in Sarepta-lead studies.

Develop and foster a culture of new innovative ideas and programs around feasibility to continue growth of the programs and department.

Provide guidance and mentoring to junior members of the Study Start-up and Feasibility Team.

Create reporting tools to measure ongoing activities and other key performance, quality, and effectiveness indicators.

Partner with Clinical Operations and CRO teams, and other key stakeholders to implement innovative feasibility efforts including collection of data within CTMS.

Support and or lead the development of Charters or SOPs as it relates to Study Start-up and Feasibility.

May have direct reports.

Qualification

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Clinical operations experienceFeasibilityStudy start-upClinical trial feasibility processVendor managementClinical study budget planningICF developmentRegulatory knowledge ICHRegulatory knowledge GCPAnalytical reasoningPowerPoint skillsLine management experienceProblem-solving ability

Required

BA / BS degree with a minimum of 10 years in the pharmaceutical or biotech industry within a clinical operations or project management role or similar.

6+ years’ experience in clinical study budget planning, and program implementation.

Strong 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 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.

Line management experience required.