How you will Achieve More with Intellia:

The Associate Director, Clinical Operations is an integral part of the leadership team for the Clinical and Development Operations organization. They are a vital team member for operational excellence of study execution in cross functional collaboration with Data Management and Biostatistics, Medical, Regulatory Affairs, Clinical Pharmacology, Clinical Supply and CMC, Drug Safety and Pharmacovigilance and other Global Development functions. They provide day to day operational oversight and/or coordination for clinical study execution

In this opportunity, your main responsibilities will include:

• Executes the day-to-day operations of a clinical study(ies) from the protocol concept through the clinical study report per established project team goals and objectives in compliance with applicable GCP/ICH guidelines, regulations, SOPs and other regulatory requirements across the globe.
• Develops and manages comprehensive study timelines and metrics
• Drives selection and management and oversight of external vendors including planning, executing study-specific meetings, key performance indicators and participates, as applicable, in vendor management governance;
• Co-leads development of clinical study synopsis and protocol in conjunction with the clinical development plan
• Develop and manage study budget and maintain within financial goals; Responsible for study budgets up to $100M
• Participates in the planning of quality assurance activities and coordinates resolution of audit findings;
• Coaches and provides guidance to clinical staff, may have management responsibilities for clinical trial management staff
• Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• May serve as subject matter expert (SME) in one or more areas such as development of SOPs, systems, tools, best in class standards for operational execution etc.

What you will bring to the table:

If you enjoy working in a fast-paced Biotech environment, have a combination of experience across study, program, and functional levels within Development Operations, then this could be just the job for you! Do you have the following?

• Bachelor’s Degree in science or a health-related field is required; advanced degree preferred

• 4 to 8 years of direct clinical trial management experience in the biotech/pharmaceutical industry
• Must have multi-trial, Phase 1, 2 and 3, global experience as a lead study manager (early phase development is a plus)
• Experience in multiple therapeutic areas or disease state/indications desirable, including life cycle management
• Strong management skills, and ability to effectively lead and collaborate with both internal and external stakeholders
• Excellent written and oral communication skills
• Demonstrated leadership, problem solving, conflict resolution, and team building skills
• Excellent knowledge of GCP, ICH, and FDA regulations with direct experience with health authority inspections
• Potential ability to travel up to 20%

Meet your future team:

This role will report directly to the Sr. Director, Clinical Operations. As part of the greater Development Operations team, the Clinical Operations group will continue to expand as our clinical trial portfolio of work continues increase. The Clinical Operations groups as well as the Development Operations team members bring an extensive range of experience and knowledge to the clinical development process. As a key member of this team, you will join a group of passionate individuals who enjoying working with one another.

Although in a virtual environment, the group and the Intellia organization has made it a priority to continue to foster a sense of community. This includes team all-hands meetings, virtual happy hours, game nights, and more! You can expect to join a hardworking, collaborative environment driven on bringing potential new therapies to patients and their families.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

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.