Senior Manager, Clinical Program Management

Location
Cambridge, MA, United States
Posted
Oct 10, 2020
Ref
411645304
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Our mission:

Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

The Senior Manager, Clinical Trial Manager will be responsible for the successful execution of clinical trials from 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.

Responsibilities:
    • Manage assigned global clinical studies encompassing all aspects from start-up through close-out (reconciliation of Trial Master File).
    • Develop and manages comprehensive study timelines and metrics.
    • Drive selection and management/oversight of external vendors including key performance indicators and participates, as applicable, in vendor management governance.
    • Plan, execute, and lead study-specific meetings (e.g., Study Management Meetings, investigator meetings, etc.).
    • Co-lead development of clinical study synopsis and protocols in conjunction with the clinical development plan.
    • Develop and manage study budget and maintain within financial goals; Responsible for study budgets up to $100M.
    • Ensure all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs.
    • Participate in the planning of quality assurance activities and coordinate resolution of audit findings.
    • Proactively identify and resolve issues, escalate as appropriate.
    • Ensure audit-ready condition of clinical trial documentation including trial master file.
    • Coordinate and assist in the planning of regulatory or ethics committee activities for clinical studies, as appropriate.
    • Assist with the writing and development of SOPs as required to ensure compliance with regulations and local laws.
    • Works cross functionally to develop internal work processes and procedures.
    • Responsible for the selection, training, and management of study personnel (contract and internal) to ensure efficient operation of the function.
    • May serve as subject matter expert (SME) in one or more areas such as systems, tools, best in class standards for operational execution, etc.


Qualifications:
    • Bachelor's Degree in science or a health-related field required; advanced degree preferred.
    • At least 6 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.
    • 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.
    • Must be able to travel up to 25%.
    • Excellent knowledge of GCP, ICH, and FDA regulations with direct experience with health authority inspections.


#LI-KD1

What Intellia Stands For:

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us - trusting and counting on every single one of us.

- Explore because we seek new ways to tackle disease. Explore with unbounded minds...free from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

- Disrupt by thinking courageously...and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts...with that breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards...even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.

POSITION: Full-Time, Exempt

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.

Intellia's web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever's privacy policy .