Associate Director, Safety Scientist
Company: Intellia Therapeutics
Location: Cambridge
Posted on: January 30, 2026
|
|
|
Job Description:
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: One, Explore, Disrupt,
Deliver and feel strongly that you can achieve more at Intellia. We
have a single-minded determination to excel and succeed together.
We believe in the power of curiosity and pushing boundaries. We
welcome challenging thoughts and imagination to develop innovative
solutions. And we know that patients are counting on us to make the
promise a reality, so we must maintain high standards and get it
done. We wantall ofour people to go beyond what is possible. We
aren’t constrained by typical end rails, and we aren’t out to just
“treat” people. We’re all in this for something more. We’re driven
to cure and motivated for change. Just imagine the possibilities of
what we can do together. Experienced Safety Surveillance and Risk
Management Scientist with a degree in life sciences (Pharmacy
degree, Nursing degree or master’s degree in health-related field)
and 10 years’ experience in safety surveillance and safety risk
management. Have an in depth understanding on FDA and EU-GVP
guidance on safety signal management, periodic report development,
safety risk management and benefit-risk assessment. Detail-oriented
and have strong written, organizational and communication skills.
Will work collectively with all relevant functions for DSPV
including R&D medicine, clinical operations, data management,
biostatics, regulatory, quality, manufacturing and medical affairs.
Duties/Responsibilities Performs proactive safety monitoring and
signal detection for assigned products and presents the findings to
cross-functional team and safety governance meetings. Authors
signal assessment report as part of signal detection process,
develop safety monitoring plan and pharmacovigilance plan as
required. Manages cross-functional safety management team for the
assigned product(s). Authors safety risk management plan for
products under clinical development and post-marketing. Authors
safety sections/modules for BLA/MAA submission dossier (SCS, ISS,
Clinical overview). Oversight on the activities related to the
periodic reports preparation (DSUR) in collaboration with the
assigned external vendor(s). Authors and/or reviews documents or
sections of key documents as they relate to safety and safety
monitoring (e.g.: protocols, protocol amendments, Investigator
Brochures, Informed Consent Forms etc Authors and/or reviews
section of key CRO documents as they relate to safety and safety
monitoring (Safety Management Plan, Medical Monitoring Plan, SAE
Reporting, Communications plan, etc. Contribute to the development
and revision of safety surveillance & risk management SOPs,
template. Collaborate with PV Operation team on medical review of
ICSRs and clinical study team on safety surveillance deliverables
for the assigned product. Participate in PV audit and inspections.
Participate in PV audit and inspections Requirements
Skills/Abilities Excellent verbal and written communication skills.
Excellent interpersonal and customer service skills. Excellent
sales and customer service skills. Excellent organizational skills
and attention to detail. Excellent time management skills with a
proven ability to meet deadlines. Strong analytical and
problem-solving skills. Proficient with Microsoft Office Suite or
related software. Education / Certifications Degree in life science
(pharmacy , nursing or MS in health related field) Advanced degree
in epidemiology (desired) Experience At least 5 years of experience
from pharmaceutical/biotech companies predominantly in safety
surveillance and safety risk management. Physical Requirements
Prolonged periods of sitting at a desk and working on a computer
LI-Remote 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. Applications are accepted on a
rolling basis, and will continue to be accepted until the position
is filled at which point the position will be taken down. The base
salary for this position is expected to range between $178,880.00 -
$218,632.00 USD per year. The salary offered is determined based on
a range of factors including, but not limited to, relevant
education and training, overall related experience, specialized,
rare or in-demand skill sets, internal comparators and other
business needs. Upon joining Intellia, your salary will be reviewed
periodically and additional factors such as time in role and
performance will be considered. Intellia may change the published
salary range based on company and market factors. Additional
compensation includes a performance-based annual cash bonus, a new
hire equity grant, and eligibility to be considered for annual
equity awards the value of which are determined annually at the
Company’s discretion. For more information about Intellia’s
benefits, please click here .
Keywords: Intellia Therapeutics, Worcester , Associate Director, Safety Scientist, Science, Research & Development , Cambridge, Massachusetts