Clinical Operations Expert
4 weeks ago
The Associate Director of Clinical Operations will provide leadership and strategic oversight of the Incyte pipeline in the UK and Ireland. This role is responsible for planning and executing clinical trials, ensuring compliance with quality standards, and collaborating with cross-functional teams to drive drug development strategy.
Key Responsibilities
- Lead the planning, execution, and oversight of clinical operations activities in the UK and Ireland.
- Collaborate with Development Operations and countries to ensure alignment on country strategy, execution, and follow-up for outsourced and internal clinical trials.
- Act as the country Clinical Operations expert and point of contact for Development Operations to support the timely and efficient set-up and maintenance of outsourced and internal clinical trials.
- Develop and maintain effective relationships with key investigators, research institutions, and stakeholders.
- Represent the country within Regional Clinical Operations and actively lead initiatives and workstreams to position the country in the context of Incyte pipeline development.
- Ensure country inspection readiness by developing country work instructions, procedures, and SOPs, as needed.
- Track country KPIs and implement corrective actions as needed.
- Provide inputs and contribute to the improvement of Development Operations SOPs and processes.
- Perform other duties as assigned by Development Operations management.
Requirements
- Minimum Bachelor of Science degree or equivalent degree.
- Minimum of 5-7 years of experience working in clinical operations within the biopharmaceutical industry and/or Clinical Research Organization (CRO), including at least 3 years in a role of primary responsibility for clinical trial execution and management.
- Operational and direct managerial experience in the planning, executing, and reporting of clinical trials.
- Must have experience in appropriate therapeutic areas; preference in one or more of the following: Oncology, Dermatology, and Immunology.
- Proven ability to manage multiple tasks simultaneously and to lead a multi-disciplinary team.
- Proven ability to work in a matrix organization.
- Experience in developing effective relationships with key investigators.
- Good knowledge of GCP, clinical trial design, statistics, regulatory processes, inspection readiness, and drug development process.
- Excellent organizational, problem-solving, and written/verbal communication skills.
- Goal-oriented, self-starter with proven ability to work independently in accordance with stated timelines and quality.
- Must be able to travel (domestic and international) up to 10%.
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