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Senior Medical Director, Drug Safety & Pharmacovigilance

Company: Intellia Therapeutics
Location: Cambridge
Posted on: March 19, 2023

Job Description:

Senior Medical Director, Drug Safety & Pharmacovigilance page is loaded Senior Medical Director, Drug Safety & Pharmacovigilance Apply locations Cambridge, MA time type Full time posted on Posted 30+ Days Ago job requisition id R779 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 want all of our 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:We are excited to welcome this new member to our growing team and company. This is both a strategic and hands-on role. 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 Medical Safety Lead, you will lead and work on various projects including but not limited to:

  • Develop strategy for Safety surveillance for the clinical trials across platform in collaboration with clinical development team
  • Manage safety signals and lead cross-functional safety management team
  • Lead DSPV in various cross-functional teams (e.g., Clinical program teams)
  • Perform medical review of SAEs, SUSARs and aggregate safety data from all sources in collaboration with CRO medical monitors
  • Lead the development of safety risk management plans, IND annual safety reports
  • Develop and update RSIs for IBs
  • Develop and contribute for BLA safety deliverables and regulatory responses
  • Develop and contribute for safety surveillance SOPs, participate in PV audit and inspections
  • Collaborate with PV Operation on DSPV functional deliverables
  • Supervise, coach and mentor safety/risk management scientistsAbout You:You are an experienced safety physician with solid clinical experience from direct patient care (clinical experience in Oncology or Immunology preferred) and 10+ years of experience in drug safety and pharmacovigilance. You are to lead and work in a fast paced, growing drug safety & pharmacovigilance department where your knowledge and hands-on experience of the good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines will contribute to establish a state-of-the-art safety surveillance team. You have prior experience in leading and authoring safety sections of IND or BLA submission dossiers. 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 degree 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 a 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. This role has the ability to work remotelyCovid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.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. About Us 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.

Keywords: Intellia Therapeutics, Cambridge , Senior Medical Director, Drug Safety & Pharmacovigilance, Healthcare , Cambridge, Massachusetts

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