Senior Director, Clinical Operations

Job Summary (Primary Function)

The Senior Director, Clinical Operations is responsible for providing strategic planning, tactical implementation, and reporting of clinical investigations involving human subjects. The position would be responsible for management of clinical studies to ensure compliance with corporate objectives, regulatory requirements and appropriate guidance, direction of clinical operations personnel, contract research organizations, consultants, core laboratories, and all other study support organizations for assigned clinical trials. The workload of direct trial responsible may depend on the workload and complexity of the trials. This position is also responsible for program level activities as assigned. Finally, this position is accountable for the day-to-day clinical development operational plans in accordance with budget and timelines and with standard operating procedures (SOP), ICH Good Clinical Practices and any other specific country regulations.

Essential Functions Of The Job (Key Responsibilities)

• Provide clear objectives, ongoing feedback and end of performance review for direct reports.
• Maintain and develop Investigator sites and KOLs relationship.
• Maintaining close collaboration with clinical development, other internal departments and external vendors.
• Contribute to the hiring plan and staffing activities including efficient on-boarding, training and mentoring of new employees.
• Clinical Trial Managers and Clinical Trial Specialists to resource the studies across the compound.
• Provides updates and status reports to Sr. Management, as requested.
• Contribute to the hiring plan and staffing activities including efficient on-boarding, training and mentoring of new employees.
• Align the Clinical Trial Heads.
• Aid for clinical program/trials implementation including operational feasibility, resource forecast and management across the compound.
• Collaborate with Sr. Management to determine clinical supply requirements for clinical trials/program.
• Participate in the strategy, design, development and review of clinical trial protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents and study reports; participate as required in the preparation of the clinical contribution to IND's, Investigational Brochure, regulatory Briefing Documents, and other relevant documentation.
• Plan, implement and manage, in collaboration with CRO partners, Phase I-III clinical trials, as necessary.
• Collaborate with Sr. Management, internal project team and CRO partners, as applicable, to prepare clinical trials/program timelines, budget and key deliverables consistent with departmental and corporate objectives.
• Aid in the preparation of 'Requests for Proposal' documents and financial analysis of CRO proposal costs and negotiation.
• Aid in the strategic oversight of the Clinical Research Organization (CRO) and other vendors.
• Aid in the development and writing of clinical Trials/program documents and manuals as appropriate.
• Accountable for development and execution of accurate operational Development plans, including assuring harmonization and high data quality across clinical trials/program.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Bachelor of Science degree or a degree in a field relevant to a profession in biopharmaceutical industry.
• Minimum of 8 years of experience working in project management and/or clinical operations within the biopharmaceutical industries and/or Clinical Research Organization ('CRO') and at least 3 years in a role of primary clinical trial design, execution and management required.
• Good knowledge of GCPs, clinical trial design, statistics, regulatory processes, and drug development process.
• Proven ability to lead multi-disciplinary teams.
• Must have the ability to develop and administer budgets, schedules and performance requirements, direct resources effectively, meet company objectives, provide technical advice and assist with problem resolution and work well under pressure.
• Experience in developing effective relationships with key investigators.
• Must have experience in appropriate therapeutic area; preference in Oncology.
• Experience in program management preferred.
• Operational and direct managerial experience in the planning, executing and reporting of global clinical development trials.
• Must be able to travel (domestic and international) up to 10%.

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. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: http://www.incyte.com/privacy-policy