Director/Associate Director, Clinical Operation

Job Description

Director/Associate Director, Clinical Operation The Clinical Operations Director is responsible for clinical study planning, execution, timelines and budgets for the assigned clinical development studies/program(s). These responsibilities include, but are not limited to vendor identification and selection, preparation of study related materials, relationship management between study sites and vendors: in particular, oversight of CRO(s), study related activities, identification of project risks and contingency planning, as well as ensuring all activities are in compliance with GCP, ICH and other relevant guidance. Reports To: Head of AP Clinical Operations. Key Responsibilities: Providing strategic input and execution of clinical trials 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. Leverage resources, expertise, and knowledge within the CRO/vendor for smooth study execution. 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, systems and initiatives. Collaborating with oversight leads 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). Managing and serving as the primary escalation point for internal and external team activities and serves as a key stakeholder for Clinical Operations within Sironax. Represents 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. Up to 30% domestic and/or international travel. Responsible for line management, professional development, and mentorship of direct report(s) including providing feedback on employee performance and goal setting. Who will thrive in this role? B.S/B.A. degree is preferred in a science/health care related field. 8+ years' experience working within a pharmaceutical/biotech company, CRO, or similar organization. 6+ years’ experience managing clinical trials, early phase experience is a must. 4 years experience as a CRA. Experience with global trial program execution preferred. Strong knowledge of ICH/GCP/local regulations. 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. Provide creative solutions when faced with unique problems/emerging situations. Reputation as an open, available, and transparent communicator. Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships. Facilitates productive dialogue that empowers others to share input/recommendations/perspective. Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex concepts to audiences with differing levels of experience. Demonstrated ability to effectively navigate and manage within a matrixed organization. Demonstrated ability to inspire, motivate and mentor teams. #J-18808-Ljbffr