Intellia Therapeutics, Inc. · 10 hours ago
Associate Director, Safety Scientist
United States
Full-time
Remote
Lead/Staff, Director/Executive
$179K/yr - $219K/yr
5+ years expIntellia Therapeutics, Inc. is dedicated to developing curative genome editing treatments for severe diseases. They are seeking an experienced Safety Scientist to manage safety surveillance and risk management for assigned products, ensuring compliance with FDA and EU-GVP guidance.
BiotechnologyGeneticsHealth CareMedicalTherapeutics
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
Qualification
Required
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)
10+ years' experience in safety surveillance and safety risk management
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
Excellent verbal and written communication skills
Excellent interpersonal 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
At least 5 years of experience from pharmaceutical/biotech companies predominantly in safety surveillance and safety risk management
Prolonged periods of sitting at a desk and working on a computer
Preferred
Advanced degree in epidemiology
Benefits
Performance-based annual cash bonus
New hire equity grant
Eligibility to be considered for annual equity awards
Company
Intellia Therapeutics, Inc.
Intellia Therapeutics is a leading genome editing company whose mission is to develop potentially curative gene editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
501-1000 employees
H1B Sponsorship
Intellia Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (38)
2023 (63)
2022 (46)
2021 (10)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.54BKey Investors
OrbiMed
2022-11-30Post Ipo Equity· $300M
2021-06-30Post Ipo Equity· $690M
2020-11-30Post Ipo Equity· $201M
Leadership Team
John Leonard
President and Chief Executive Officer, Member Board of Directors
Edward Dulac
Chief Financial Officer
Recent News
Labiotech UG
2026-01-22
Clinical Trials Arena
2026-01-16
Company data provided by crunchbase