Director, Clinical Program Management
Company: Intellia Therapeutics, Inc.
Location: Cambridge
Posted on: February 20, 2021
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Job Description:
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 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. 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. In the next window
you will be prompted to create a candidate account. You can log
into your candidate account anytime to view the status of your job
application(s). Intellia Therapeutics and the Intellia Therapeutics
logo are registered trademarks with the U.S. Patent & Trademark
Office.
Keywords: Intellia Therapeutics, Inc., Cambridge , Director, Clinical Program Management, Executive , Cambridge, Massachusetts
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