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Director, Clinical Program Management

Employer
Intellia Therapeutics
Location
Cambridge, MA, United States
Start date
Dec 16, 2020

View more

Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown

Job Details

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.

Job Description:

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.

Responsibilities
  • 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


Qualifications
  • 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


#LI-KD1

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.

Company

Many of us pursuing work in the biotechnology industry are inspired by a loved one who is living with a disease or the loss of someone in our community. Rare genetic and oncological and immunological diseases not only affect the people living with often debilitating and life-threatening symptoms, but these disorders also significantly impact their families, friends and caregivers.
 
Our researchers work tirelessly to harness the genome editing technology CRISPR/Cas9 for human therapeutic use. Jennifer Doudna, an Intellia co-founder, and Emmanuelle Charpentier were awarded the 2020 Nobel Prize in Chemistry for their pioneering work in CRISPR. We at Intellia are humbled to have a hand in making what we believe to be medical history. As a leader in this space, we take this responsibility to patients seriously.
 
We are employing a modular genome editing platform to create diverse in vivo and ex vivo pipelines, spanning a range of therapeutic indications. Guided by this full-spectrum approach, we are committed to making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to creating novel engineered cell therapies for various cancers and autoimmune diseases.

Change life stories with genome editing therapies!

Stock Symbol: NTLA

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Company info
Website
Phone
(857) 285-6200
Location
40 Erie Street
Cambridge
Massachusetts
02139
United States

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