Director, Safety Risk Management Scientist

5 days ago

Cambridge, Massachusetts, United States Intellia Therapeutics Full time

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.

Why JoinIntellia?

Our mission is to developcurativegenome 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. Wearen'tconstrained by typical end rails, and wearen'tout to just "treat" people.We'reall in this for something more.We'redriven to cure and motivated for change. Just imagine the possibilities of what we can do together.

How you will Achieve More with Intellia:

We are excited to welcome this new member to our growing team and company. This role collaborates with the safety physician and clinical development team for safety surveillance, safety risk management and benefit-risk evaluations for the assigned products. This role requires strong safety surveillance and risk management experience with products in clinical development and post-marketing settings including experiences with global IND and or BLA/MAA submissions.

If you are a strong problem-solver, agile with detailed regulations and requirements for global safety surveillance & safety risk management and enjoy cross-functional partnerships, this is the role for you As the Safety Risk Management Scientist, you will lead and work on various projects including but not limited to:

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-marketingAuthors 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, templatesCollaborate with PV Operation team on medical review of ICSRs and clinical study team on safety surveillance deliverables for the assigned productsParticipate in PV audit and inspectionsAbout You: You are an experienced safety surveillance and risk management scientist with a degree in life sciences (Pharmacy degree, Nursing degree or MS in health-related field) and 10+ years' experience in safety surveillance and risk management (experience in rare diseases, oncology or immunology therapeutic areas preferred). You have in depth understanding on FDA and EU-GVP guidance on safety signal management, periodic report development and safety risk management. You are detail-oriented and have strong written, organizational and communication skills. You are intrigued by the new challenges to pharmacovigilance that accompanies novel gene editing therapies. Your prior experience with gene therapy products or biologics and advanced trainings in epidemiology will be plus. On a product/program team, you work collectively with all relevant functions for DSPV including medical, clinical operations, data management, biostatics, regulatory, quality and manufacturing. Meet your future team: Intellia strives to form an experienced, patient-focused drug safety & pharmacovigilance (DSPV) function. The present team is comprised of small team of experienced PV professionals including Safety physician, safety scientist, PV operations lead and the functional head. Plans are in place to build a team of knowledgeable and conscientious pharmacovigilance professionals to support our growing portfolio. 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.

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