Director, Head of Clinical Operation
The Director/Head of Clinical Operation oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. He or she will participate in cross-functional teams to generate, deliver, and interpret high-quality clinical data to support overall product scientific and business strategies.
· Articulate and share vision with senior management about generating high quality clinical trial data in consideration of local healthcare systems, costs, regulatory environment, existing medical expertise, and disease prevalence.
· Translate corporate strategy into executable action plans and establish priorities in alignment with company goals and priorities. Manage team workload based on identified priorities by anticipating and initiating actions in response to multiple challenging demands to ensure the execution of goals.
· Responsible for ensuring execution of clinical trials. Proactively identify key issues internally and externally in clinical trial execution and propose appropriate solutions, and ensure compliance with company policies, regulations, and international/local guidelines.
· Develop and track metrics to evaluate processes on a regular basis and solutions for issues, identify new initiatives for implementation. Maximize all opportunities and remain current with broader organizational challenges to facilitate effective partnerships.
· Manage high-performing teams of line managers, area study directors, project managers, clinical site managers, clinical site monitors, clinical trial associates, administrative assistants, and other roles as relevant.
· Build effective working relationship with all key stakeholders, including internal matrix team members, both locally and centrally, as well as external customers (site staff). Partner with key stakeholders as a main point of contact to effectively communicate and create an understanding and awareness of the local environment and culture related to business for maximizing opportunities and risk management.
· Responsible for the administration of team budget and operating expenses.
· Responsible for representing or selecting appropriate team members to represent the organization at inspections by external regulatory authorities and implementing action items in compliance with the inspection outcomes.
· Bachelor’s degree or higher in bioscience.
· A minimum of 5 years of experience in the pharmaceutical industry
· Excellent oral and written skills, strong interpersonal and listening skills.
· Result-driven to achieve creative and sound outcomes.
· Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.
· Ability to deal with ambiguity and make sound and timely decisions, agile in learning and actions.
· Ability to interact with different levels of employees across the organization, set priorities for team, maintain accountability, and build effective teams.
· Experience in managing and developing team members.
· Excellent English and fluent Mandarin.