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Associate Director, Global Clinical Operations

Company: Sarepta Therapeutics
Location: Somerville
Posted on: January 12, 2021

Job Description:

The Associate Director, Global Clinical Operations will function in a strategic leadership role as the Sr. Clinical Program Leader (Sr. CPL) accountable for managing the overall execution of assigned clinical programs. S/he will make or recommend operational strategies and/or decisions in support of achieving clinical program objectives. The Sr. CPL is also accountable for functional management including recruiting, building and maintaining a high-quality Clinical Operations team.Primary Responsibilities Include: Contributes to the development of the target product profiles, CDPs including scenario planning, high-level forecasting of timelines, assesses program level feasibility, estimation and allocation of resources and budget, and development of high-level operational strategiesAccountable for meeting all operational deliverables in accordance with the timeline, cost and quality commitmentsMaintains an overview of status, issues, and proactively communicates progress, issues or changes that may impact timelines and costs of the program to all stakeholdersEnsures internal consistency across studies within a program and ensures alignment of operational program to the development team goalsActively leads a highly performing Development Team (DT) and ensures appropriate strategic topics are discussed and managedCollaborates with Core DT members to ensure that the program has a Clinical Development Plan (CDP) that meets the strategic objective of the asset/program plan and has been updated and approved by appropriate approval/governance bodies at appropriate time pointsIn conjunction with Lead MD responsible to report on the status of the CDP and clinical programMay represent DT and GCDO as a key Asset Team MemberIdentify program risks and develop and implement mitigation strategies for assigned programsParticipate in and/or lead working groups and/or initiatives within the Global Clinical Development Operations (GCDO) organization or cross functionally as requiredMay interface with to key external stakeholders (KOL---s, advocacy groups, partners etc.)Management Responsibilities:Provides program leadership to the clinical trial teams with program specific guidance, clinical trial management expertise, operational strategies, and direction to achieve results.Mentors and coaches--- staff (direct and dotted-line reports), provides timely feedback to functional managers regarding staffing needs and individual performance in the programProvides coaching, mentoring, performance and talent management, and succession planning. Identifies, recruits, hires, and develops Clinical Operations staff, as well as oversees their work to ensure all department goals, deliverables, and objectives are met.Ensures that employees are appropriately trained and comply with company and regulatory standardsCreates a positive work environment by encouraging mutual respect, innovation and accountability. Creates and maintains Clinical Operations as a great place to workResources projects to enable teams to meet deliverablesActively participates and contributes to internal and external governanceSponsors, leads and/or participates in critical department or broad organizational, cross-functional initiativesEducation and Skills Requirement:Bachelor---s degree in health sciences or related field.Minimum of 13 years of experience in clinical research with at least 7 years of experience in clinical study management across phases.Experience with managing and demonstrating oversight of CROs, vendors, and consultants.Experience with managing or mentoring employees directly or indirectly.Extensive knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials.Prior regulatory inspection experience preferredExperience developing trial plans including site monitoring, risk mitigation strategies, trial budgets, site selection and clinical supply management.Proficient written and verbal communication skills.Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and CompassionPosition may require some travelCandidates 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.Full time

Keywords: Sarepta Therapeutics, Somerville , Associate Director, Global Clinical Operations, Executive , Somerville, Massachusetts

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