Job Summary (Primary function)
Associate Director Clinical Operation is the Regional Clinical Operation (ReCO) tactical expert responsible to provide leadership and strategic oversight of the Incyte pipelines, provide adequate planning and operational delivery of assigned clinical studies, in accordance with the appropriate quality standards, including ICH/GCP standards, Incyte SOPs, Country operating guidelines and Country requirements, as applicable, in the territory assigned (Australia and New Zealand) (Territory).
Duties include but are not limited to: (1) direct/indirect management and support of Country Clinical Operations teams including providing inputs with regards to resource assignment, development, training, and performance review (2) oversight of programs/clinical studies to ensure their implementation and progress (3) a key partner with Development Operations (e.g Asset Leads and Global Clinical Trial Managers) and Development Operations senior management stakeholders, as required, in all aspects of drug development strategy and management.
Essential Functions of the Job (Key responsibilities)
Is responsible for the strategy building and planning, execution and oversight of Clinical Operation activities in the Territory.
Collaborates with Development Operations (eg. Asset Leads, Global Clinical Trial Managers) and Country representatives (eg. Medical Affairs) as appropriate to ensure continuous alignment on Country strategy, execution, follow-up and support for outsourced and in-house clinical studies in the Territory.
Acts as the Country Clinical Operations expert/point of contact for the Development Operations (eg. Asset Leads, Global Clinical Trial Managers) to support the timely and efficient site set-up and maintenance of outsourced and in-house clinical studies in the Territory.
Demonstrates ability in working in a matrix organization by partnering with Country Organizations, Development Operations and Clinical Development to identify investigators, clinical experts, cooperative groups, and build Country network that support pipeline development in all therapeutic areas in the Territory.
Represents Incyte externally and build relationships, including a master agreement of clinical trials, when possible, with key research institutions and investigators in the Territory.
Communicates and updates on regular basis on clinical trial activities and strategy in the Territory with Development Operations (eg. Asset Leads, Global Clinical Trial Managers) and ReCO Asia Pacific Head.
Assures Country inspection readiness by developing Country work instructions, procedures, SOPs, as needed and applicable by liaising with the respective relevant functions (e.g. Clinical QA) in the Territory.
Tracks Country KPI (e.g. Country enrolment target) to ensure high performance and implement corrective actions as needed in the Territory.
Provides Country inputs and contributes to the improvement of Development Operations SOPs and processes (Global, Regional and Country level).
Identifies gaps and lead and implement Country SOPs/WIs and processes in collaboration with other departments as needed.
Manages Country Clinical Operations resources based on activities and engagement (current and future pipeline development) in the Territoy.
Conducts performance reviews of direct reports with support as needed. Oversees proper handover and training documentation for internal monitoring activities.
Implements individual development plan of direct reports with support as needed.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Minimum Bachelor of Science degree or equivalent degree
Minimum of 5-7 years’ experience working in Clinical Operations within the biopharmaceutical industries and/or Clinical Research Organization (‘CRO’) including a role of primary responsibility for clinical study execution and management.
Operational and direct managerial experience in the planning, executing and reporting of clinical studies.
Have experience in appropriate therapeutic areas; Oncology, Hematology, Inflammatory Diseases (preferable)
Experience in developing effective relationships with key investigators.
Language Proficiency
Have capabilities of business level languages: English.
Proven ability to manage multiple tasks simultaneously and to lead multi-disciplinary teams.
Good knowledge of GCP, clinical study design, statistics, regulatory processes, inspection readiness and drug development process.
Proven ability to work in a matrix organization.
Excellent organizational, problem-solving, and written/verbal communication/presentation skills.
Goal oriented, self-starter with proven ability to work independently in accordance with stated timelines and quality.
Effective organizational and time management skills.
Proven flexibility and adaptability.
Available for domestic and international travel.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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