Executive Director, Clinical Operations – Regional Head

Executive Director, Clinical Operations – Regional Head - JAPAC Provides input into JAPAC regional strategic and operational short- and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation. Provides leadership, guidance, oversight and therapeutic expertise for the successful management of all aspects of clinical trials. Responsible for the strategic, operational and financial oversight of all program(s) within the region. Develops, implements, manages and ensures completion of clinical trials within regional designated budgets and timelines. Sets the regional strategic vision for assigned clinical trials / programs by working cross-functionally with all relevant stakeholders. Assesses, on-boards and manages regional contract research organizations (CROs) and other vendors to ensure success of assigned trials / programs, including requests for proposals (RFPs) and selection processes. Contributes to the regional strategic implementation of Clinical Development Program(s) for specific programs as a member of the Clinical Sub-Team and may sit on the Global Development Team, dependent upon the program’s priority and breadth. Oversees regional representation of local Study Management Team(SMT) members and influences relevant stakeholders. Performs regional strategic analysis of project status and issues; ensuring robust risk mitigation strategies are in place. Anticipates complex obstacles and implements solutions to achieve project goals. Solves problems relating to national regulations, guidelines and investigator interactions. Keeps all stakeholders appropriately and timeously advised on all aspects of project status and any issues. Partners with General Managers within the JAPAC region and other key regional stakeholders to ensure seamless execution. Ensures building of strong regional site partnerships (Sponsor of Choice) through management of Clinical Site Partners within the region. Uses all available tools to track, oversee and communicate on program status to all key stakeholders. Contributes leadership input into all regional study-related documentation, including study protocols. Responsible for Clinical Operations activities conducted by the regional affiliates that are required by local regulations and/or usual practice to support clinical trials. May contribute to standard operating procedure (SOP) development, implementation and training as it relates to the region. Ensures team’s work complies with established practices, policies and processes, and any regulatory or other regional requirements. People Leader Path: Hires, develops and retains diverse top talent on the team. Sets clear expectations for the team and individuals direct reports. Coaches direct reports on their performance, development and career interests. May play a central role in developing other people leaders. REQUIREMENTS We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. BA / BS / RN with 14 or more years’ relevant clinical or related experience in life sciences. Or, MA / MS / PharmD / PhD with 12 or more years’ relevant clinical or related experience in life sciences. Typically has a minimum of 12 years’ cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing study management or project teams. Experience developing RFPs and selection and management of CROs or other vendors. Proven ability to successfully manage clinical studies within designated program budgets and timelines, including significant expertise in authoring clinical study and regulatory documentation and SOPs. Meets all requirements for a Director (D) grade 32 position with demonstrable proficiency. Knowledge & Other Requirements Exhibits exceptional knowledge of various disease or therapeutic areas (Oncology, Virology, Inflammation), as evidenced by applying leading-edge knowledge and leadership of oversight for multiple clinical programs and Phases (Ph 1 – 3. Mandatory Post Marketing) across the region. Demonstrates expert knowledge of full cycle study management, from start-up to close-out to direct staff effectively. Develops solutions which extend knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness. Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use ( ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies. Strong financial acumen necessary for the management of clinical programs. Proven ability to effectively author clinical study and regulatory documentation. Demonstrates exceptional strategic leader presence with demonstrated ability to lead without authority and influence programs with an enterprise mindset. Strong interpersonal skills and understanding of team dynamics. Strong communication and organizational skills. Often acts independently to uncover and resolve issues associated with the development and implementation of operational programs. Can employ change management that significantly influences multiple projects at a large or high profile scale. As required, the ability to travel. #J-18808-Ljbffr