Associate Director, Clinical Operations

Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our science, we live our four core values: Explore, Disrupt, Deliver. We believe in the power of curiosity and pushing boundaries, welcoming challenging thoughts and imagination to develop innovative solutions. We know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

As Associate Director, Clinical Operations within the Development Operations organization, you are an integral part of the leadership team. You 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. You provide day to day operational oversight and/or coordination for clinical study execution.

Duties/Responsibilities

• Execute 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.
• Develop and manage comprehensive study timelines and metrics.
• Drive selection and management and oversight of external vendors including planning, executing study-specific meetings, key performance indicators and participate, as applicable, in vendor management governance.
• Co-lead 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.
• Participate in the planning of quality assurance activities and coordinates resolution of audit findings.
• 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.

Supervisory Responsibilities

• Coach and provide guidance to clinical staff, may have management responsibilities for clinical trial management staff.
• Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.

Requirements

Skills/Abilities

• 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.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to function well in a high-paced and at times stressful environment.
• Proficient with Microsoft Office Suite or related software.
• Ability to travel up to 20%.

Education / Certifications

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

Experience

At least 4 to 8 years of direct clinical trial management experience in the biotech/pharmaceutical industry.

Physical Requirements

Ability to sit or stand for multiple hours at a computer; manual dexterity for keyboarding; may include repetitive movements.

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.