Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.The Director / Sr. Director, Clinical Program Management is a strategic role responsible for overseeing cross-functional clinical core and steering committee teams and clinical operational plans for Phase 2 and Phase 3 pivotal and Safety trials for Rilparencel. This experienced candidate will report to the VP of Program Leadership and Management in the PMO while partnering with clinical leaders for project execution.
Ideal candidates will demonstrate strength in communication and organizational skills to succeed in a highly cross-functional role and be broadly engaged across the company. In this position you will bring strong late-stage clinical drug development program management experience and the ability to build and deploy tools and best practices to ensure the successful execution of Rilparencel clinical trials.
Key Responsibilities: Lead and oversee project management operations of key clinical teams for Rilparencel.Collaborate cross-functionally with internal and external teams, including Clinical Operations, Clinical Development, Regulatory Affairs, Biostatistics, Clinical Quality Assurance, Pharmacovigilance, Technical Operations, and Leadership, to ensure alignment on clinical trial objectives and milestones.Give clear guidance and direction to teams if deviating from strategic plans and business objectives.Drive team decision-making and execution of agreed-upon program plans, manage team accountability, cross-functional integration, and overall program transparency to key stakeholders.Work with cross-functional clinical team members to set strategic meeting agendas, schedule meetings, draft meeting minutes, document key decisions and track actions to completion.Develop and track clinical study plans and timelines to define critical path activities, key program infection points, strategic decisions and milestones.Identify, manage and communicate clinical program risks and mitigation approaches.Draft clinical status-report dashboards and presentations for executive communications as needed.Utilize effective communication skills to facilitate appropriate information exchange between functional leads, core teams and senior management.What skills and experience you'll bring: BA/BS preferably in a health-related field, advanced degree a plus, with major in biological, life science, nursing or related field.8+ years of experience in late-stage clinical development and/or clinical operations within the pharmaceutical or biotechnology industry, cell therapy experience is a plus.Phase 3, registrational clinical experience preferred.Advanced experience building and leading clinical teams.Advanced meeting facilitation skills.Understanding of global regulatory and compliance requirements for clinical research.Demonstration of strategic thinking and high-level planning while also balancing execution of operational details.Ability to effectively manage multiple projects with competing priorities and adapt to change.Comfortable working in a fast-paced environment.Advanced user knowledge of Office365 applications, ie., PowerPoint, Excel, Word, and Project Management tools, templates, ie., Smartsheet, Think-Cell.Strong collaboration and teamwork disposition and demonstrated capability to lead with ProKidney leadership principles of Transparency, Respect, Accountability and Collaboration.ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.
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