The Clinical Program Manager (CPM) is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements across the globe. In addition, the individual will contribute to the development of SOPs, clinical development plans, and other company initiatives as required. This position reports to Senior Director, Clinical Program Management.
Manage one or more assigned global clinical studies encompassing all aspects from start-up through close-out (reconciliation of Trial Master File)
May serve as subject matter expert (SME) in one or more areas such as systems, tools, best in class standards for operational execution etc.
Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
Works cross functionally to develop internal work processes
Collaborates with Clinical Program Management leadership on the growth of department
Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws
Coaches and provides guidance to clinical staff, may have management responsibilities for clinical trial management staff
Coordinates and assists in the planning of regulatory or ethics committee activities for the clinical study, as appropriate.
Ensures audit-ready condition of clinical trial documentation including trial master file;
Proactively identify and resolve issues and manage escalation as appropriate.
Participates in the planning of quality assurance activities and coordinates resolution of audit findings;
Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs:
Develop and manage study budget and maintain within financial goals; Responsible for study budgets up to $100M
Co-leads development of clinical study synopsis and protocol in conjunction with the clinical development plan
Plans, executes, and leads study-specific meetings (e.g., Study Management Meetings, investigator meetings, etc.);
Drives selection and management/oversight of external vendors including key performance indicators and participates, as applicable, in vendor management governance;
Develops and manages comprehensive study timelines and metrics
Bachelor’s Degree in science or a health-related field is required; advanced degree preferred
6 to 8 years of direct clinical trial management experience in the biotech/pharmaceutical industry
Must have multi-trial, Phase 2/3, global experience as a lead study manager
Excellent knowledge of GCP, ICH, and FDA regulations with direct experience with health authority inspections
Must be able to travel up to 20%
Demonstrated leadership, problem solving, conflict resolution, and team building skills
Excellent written and oral communication skills
Strong management skills, and ability to effectively lead and collaborate with both internal and external stakeholders
Experience in multiple therapeutic areas or disease state/indications desirable, including life cycle management
EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.