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Director, Clinical Development Operations
Department: Clinical Development
Reports to: Vice President, Clinical Development
Location: Office US-based
Summary of job description:
As a member of the Replimune Clinical Development management team, the Clinical Development Operations Director will support the clinical development programs for the Replimune clinical studies. The Director of Clinical Development will provide leadership, project management, and program oversight to plan and conduct one or more high quality clinical trials concurrently in accordance with CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions. The Director of Clinical Development Operations will manage all operational aspects of clinical development projects.
- Responsible and accountable for the conduct of clinical trials.
- Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct trials on time, on budget, in compliance, and of highest quality.
- Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
- Work collaboratively with cross functional internal and external teams including regulatory affairs, medical writing and biostatistics
- Identify, qualify, audit, and manage all external vendors, including CRO’s.
- Will take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company’s business objectives.
- Ensure clinical trial team and clinical trial sites are properly trained and in compliance protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Performs site monitoring with field team, as needed.
- Facilitates all start-up activities including but not limited to investigational site contracts, investigational sites, and ethics committee submissions.
- Facilitate confidentiality agreements, negotiate study agreements and budgets with sites and external vendors.
- Responsible for writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, DMC charter, close-out plans, and CSR’s.
- Assist with the development of presentations, handouts, and coordination of Investigator Meetings.
- Assist VP, of Clinical Development in leveraging technology solutions that support clinical trials operations and allow for visibility into trial quality and risk management
- Assist VP, of Clinical Development in development of appropriate SOPs, and other template documents for standardization of processes to ensure quality
- Advanced degree, or BS degree in science, nursing, health or related field
Experience and skill requirement:
- Minimum of 15 years of clinical research and/or clinical project management experience in domestic and international clinical trials.
- Excellent working knowledge of ICH, GCP guidelines, CFR, EMA, and HIPAA regulations.
- Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward.
- Excellent written and oral communication and presentation skills
- The ability to manage multiple priorities, while maintaining attention to detail is critical.
- Experience operating effectively within a matrixed environment, specifically in a healthcare/pharmaceutical start-up setting.
- Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
- Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels.
- Computer skills should include routine business software and trial platforms: e.g., Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms.
- Must be willing to travel up to 25%.