Associate Director, Clinical Operations

Overview
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 quality standards including ICH/GCP, Incyte SOPs, Country operating guidelines and Country requirements, in the territory assigned (Australia and New Zealand).
Duties include but are not limited to: (1) direct/indirect management and support of Country Clinical Operations teams including inputs on 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.
Responsibilities
Is responsible for the strategy building and planning, execution and oversight of Clinical Operation activities in the Territory.
Collaborates with Development Operations (e.g., Asset Leads, Global Clinical Trial Managers) and Country representatives (e.g., Medical Affairs) to ensure 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 Development Operations to support the timely site set-up and maintenance of outsourced and in-house clinical studies in the Territory.
Demonstrates ability to work in a matrix organization by partnering with Country Organizations, Development Operations and Clinical Development to identify investigators and build a country network that supports pipeline development in all therapeutic areas in the Territory.
Represents the countries in the Territory within ReCO, provides active leadership in initiatives and workstreams, and strategically positions the respective Country in the context of Incyte pipeline development.
Represents Incyte externally and builds relationships, including a master agreement of clinical trials, with key research institutions and investigators in the Territory where possible.
Communicates and updates regularly on clinical trial activities and strategy in the Territory with Development Operations and ReCO Asia Pacific Head.
Ensures Country inspection readiness by developing country work instructions, procedures, SOPs as needed and applicable by liaising with relevant functions (e.g., Clinical QA) in the Territory.
Tracks Country KPI (e.g., enrolment targets) to ensure high performance and implement corrective actions as needed.
Provides country inputs and contributes to the improvement of Development Operations SOPs and processes (Global, Regional and Country level).
Identifies gaps and leads the implementation of 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 Territory.
Conducts performance reviews of direct reports with support as needed. Oversees proper handover and training documentation for internal monitoring activities.
Implements individual development plans for direct reports with support as needed.
Qualifications
Education: Minimum Bachelor of Science degree or equivalent.
Experience: Minimum of 5-7 years' experience in Clinical Operations within biopharmaceutical industries and/or CRO, including primary responsibility for clinical study execution and management.
Operational and direct managerial experience in planning, executing and reporting of clinical studies.
Experience in relevant therapeutic areas: Oncology, Hematology, Inflammatory Diseases (preferable).
Experience developing effective relationships with key investigators.
Language Proficiency: Business-level English.
Others: Proven ability to manage multiple tasks, lead multi-disciplinary teams; good knowledge of GCP, clinical study design, statistics, regulatory processes, inspection readiness, and drug development; proven ability to work in a matrix organization; excellent organizational, problem-solving, and written/verbal communication/presentation skills; goal-oriented, self-starter, able to work independently; effective organizational and time management skills; flexibility and adaptability; available for domestic and international travel.
Disclaimer and Privacy
The above statements describe the general nature and level of work performed by employees assigned to this job. They are not an exhaustive list of duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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