Vice President, Drug Safety and Pharmacovigilance

Location: Cambridge
Posted on: June 23, 2025

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. How you will Achieve More with Intellia: The Vice President of Drug Safety and Pharmacovigilance will lead the development and execution of the company's safety strategy across all stages of product development and commercialization. This executive role requires a dynamic leader capable of overseeing pharmacovigilance operations, safety surveillance and risk management, ensuring regulatory compliance, and providing safety leadership across clinical development programs and post-marketing. Key Responsibilities: Strategic Leadership: Develop and execute a comprehensive drug safety and pharmacovigilance strategy aligned with the company's objectives and regulatory requirements. Safety Surveillance: Oversee safety signal detection, evaluation, and risk mitigation strategies for all products in the clinical and commercial pipeline. Regulatory Compliance: Ensure compliance with global safety regulations, including those from the FDA, EMA, and ICH guidelines. Team Building: Build and lead a high-performing pharmacovigilance and drug safety team, fostering a collaborative and high-performance culture. Cross-Functional Collaboration: Work closely with Clinical Development, Regulatory Affairs, and Medical Affairs to embed patient safety throughout the product lifecycle. Risk Management: Oversee the development, implementation, and maintain risk management plans, safety monitoring plans, and safety data exchange agreements for clinical programs and marketed products. Medical Oversight: Provide medical oversight for safety activities, including the review and assessment of individual case safety reports and aggregate safety data. Regulatory Interactions: Serve as the primary point of contact for pharmacovigilance interactions with regulatory authorities and external partners. Provide strategic oversight for safety sections of regulatory filings, including INDs, BLAs, NDAs, and MAAs. About You: Qualifications: Education: MD or equivalent with relevant clinical experience. Experience: Minimum of 15 years in pharmacovigilance and drug safety roles within the biotech or pharmaceutical industry, with at least 5 years in a leadership position. Therapeutic Area Expertise: Experience in gene editing or rare diseases is highly desirable. Regulatory Knowledge: Strong understanding of global safety regulations and industry standards. Proven experience with successful BLA and MAA regulatory submission and interactions that have led to approvals and product launch. Leadership Skills: Proven track record of building, managing, developing, and motivating high-performing teams and leading in a matrixed environment. Communication Skills: Excellent verbal and written communication skills, with the ability to present complex information to diverse audiences. Preferred Qualifications: Experience with safety data management systems and tools. Familiarity with the unique safety considerations of gene editing technologies. Experience in originating the safety program for the first commercial product in a biotechnology company. Demonstrated ability to navigate the safety aspects of products through late-stage development and commercialization. LI-KO1 LI-hybrid 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.

Keywords: , East Hartford , Vice President, Drug Safety and Pharmacovigilance, Science, Research & Development , Cambridge, Connecticut