Clinical Operation Director/Associate Director

Description:

We are collaborating with a rising leader in transformational therapies focused on addressing the root causes of age-related degenerative diseases. As part of their global expansion, a new opportunity has emerged for a Clinical Operations Director/Associate Director based in Australia.
About the RoleYou will oversee the planning, execution, timelines, and budgets for assigned clinical studies/programs. Key responsibilities include vendor selection, site feasibility, study material preparation, and managing relationships between study sites and vendors, particularly CROs. You will also identify project risks, develop contingency plans, and ensure compliance with GCP, ICH, and other relevant guidelines.
Key ResponsibilitiesProviding strategic input and execution of clinical trials as project lead/manager from protocol design to the final clinical study report for the assigned studies.Leading and managing integrations of study team activities, leveraging internal resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.Managing CRO/vendor identification, request for proposal submission, CRO selection, and the day-to-day operational activities.Overseeing study operations including study site selection and regulatory submissions, review of CRO monitor visit reports and site correspondence, drug supply and use, enrolment of subjects, regulatory document flow including informed consents (and translations), study timelines, all budgetary and financial information, performance metrics, data flow, etc.Participate in Case Report Form and/or EDC specification design and user acceptance testing, data management plan review, and data quality review and tracking.Effectively communicate and interact with Key Opinion Leaders.Lead the development of contingency/risk management plans for projects.Prepare budgets, timelines, and forecasts for clinical studies. Participate in development and review of Clinical Operation processes, SOP systems and initiatives.Collaborating and leading within assigned program(s) on clinical trial designs and strategy to ensure successful implementation of program(s)/trial(s) while anticipating and mitigating potential issues.Managing and overseeing financial aspects of assigned program(s) and trial(s).Present program(s)/trial(s) to senior management, cross functional teams, and external partners.Provides input and support for regulatory activities including INDs and other regulatory submissions, inspection readiness activities and serve as a subject matter expert during regulatory inspections.Ensures implementation and standardized use of Clinical Operations and Clinical Development Operations tools.
About You
M.S. degree is preferred in a science or health care related field.8+ years' project management experience working within a pharmaceutical/biotech company, CRO, or similar organization.Experience in global trial execution preferred. Strong knowledge of ICH/GCP/local regulations.Skilled at managing multiple priorities in a fast-paced environment.Proven ability to work in a fast-paced environment with demonstrated ability to prioritize and manage multiple competing tasks while maintaining timelines and ensuring overall quality and integrity.Problem-solving mindset with creative solutions. Facilitates productive dialogue that empowers others to share input/recommendations/perspective.Open, transparent communicator with strong interpersonal skills. Encourages collaboration and values diverse input.Excellent written and verbal communication, simplifying complex concepts.Demonstrated ability to effectively navigate and manage within a matrixed organization.Demonstrated ability to inspire, motivate and mentor teams.Able to travel domestically and internationally.