Director – Clinical Operations Excellence

Director – Clinical Operations Excellence

Requirements

• Bachelor’s Degree is required. An advanced degree is highly preferred.
• 7+ years of experience gained with a CRO, biotech, or pharmaceutical company
• 5+ years of clinical research in a GCP Function
• Line management experience required
• Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timely
• Ability to work independently and manage deadlines
• Problem-solving, process improvement, analytical, and collaborative skills
• Excellent oral, written, presentation and cooperation skills
• Self-motivated, calm under pressure and adaptable to a dynamic environment with the ability to support successful change
• Experience with corrective/preventive actions and effectiveness checks
• Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICH guidelines for patient registries and studies
• Experience developing trial plans including site management, risk mitigation strategies, trial budgets and program-level budgets
• Ability to collaborate effectively with study teams, cross-functional team members and external partners using collaborative negotiation skills
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project

Responsibilities

• Lead select vendor governances
• Drive and manage ongoing maintenance of Clinical Trial Operating Model (CTOM) as CTOM task force lead
• Serves as the subject matter expert and primary point for Development Operations SOPs, process oversight, and good clinical practice (GCP)
• Drives gap analysis and reconciliation of Dev ops-owned SOPs; and management of SOPs per Sarepta guidelines; support of CRO SOP gap analysis
• Drive Clinical Operations Excellence by managing Oversight activities for cross-program monitoring oversight program
• Drives certain JOC meetings and provides ongoing clinical operations oversight and support on resolution of issues
• Supports compliance activities including SOP activity and training compliance; support teams with risk management/mitigation in accordance with the requirements of ICHE6(R3)
• Manages inspection preparation activities as required
• Supports process build of clinical development process and business area SOPs as fit for purpose and in compliance with regulatory requirements; confirm SOPs are an accurate representation of the way work is executed
• Provides input and support for training sessions on best practices, trends, regulatory requirements guidance, and GCP topics to facilitate continuous improvement in quality and on-going adherence to standards and regulations
• Assists with the creation and delivery of tools, templates, training, and guidance for best practice and reporting and minimizing risk while ensuring quality is integrated into our processes
• Drives process change within Development Operations related to day-to-day processes, SOP activity, risk management/mitigation
• Assists other functional groups, as needed, on time-sensitive materials relating to Quality Issues and Events
• Drives overall Clinical Vaults, including CTMS, implementation and maintenance and be a change agent for the system within Sarepta to ensure adoption of new capabilities and business process
• Be a point-of-contact for CTMS to ensure established milestones are met
• Partner with appropriate functional stakeholders, technology vendors, and CRO partners to avoid and resolve risks and issues within the CTMS and other Clinical Vaults, as applicable
• Participate in preparing functions for submission readiness as it relates to Clinical Vaults and may represent Dev ops group in a formal inspection or audit
• Liaise with internal R&D Business Operations and R&D Quality and Compliance to execute best practice relationship infrastructures, and efficient, high quality & compliant business processes
• Assume leadership role in operational improvement initiatives
• May support additional ad-hoc activities as agreed with the Executive Director, Operational Excellence

Preferred Qualifications

• An advanced degree is highly preferred.
• Position may require some travel