- Develop a strategy for Safety surveillance for the clinical trials across the platform in collaboration with the 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)
- Lead a cross-functional project on developing guidance for long-term safety assessment of gene-editing products
- 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 IND/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 scientists About You: Are you an experienced safety physician (MD) with solid clinical experience in direct patient care (clinical experience and/or board certification in Oncology, Immunology, Clinical Genetics desired)? Do you have 10+ years of experience in drug development and in drug safety/pharmacovigilance? If you have these qualifications, and are excited about a leadership opportunity in a fast-paced, growing drug safety & pharmacovigilance department, we encourage you to apply At Intellia, your knowledge and hands-on experience with good pharmacovigilance practices and international regulatory requirements such as EMA/FDA/ICH guidelines will contribute to the establishment of a state-of-the-art safety surveillance program for novel gene-editing therapies. have experience leading and authoring safety guidance documents, position papers, safety sections of IND or BLA submission dossiers. You are intrigued by the new challenges to pharmacovigilance that accompanies novel gene editing therapies. Prior experience with gene therapy products or biologics is a plus. You will lead the safety management team for the assigned product(s) with support from safety risk management scientist(s). On a product/program team, you work collectively with all relevant functions for DSPV including medical, clinical operations, data management, biometrics, regulatory, quality and manufacturing. Meet your future team: Intellia strives to form an experienced, patient-focused drug safety & pharmacovigilance (DSPV) function. We are a lean team of experienced PV professionals including a Safety Physician, Safety Risk Management Scientists, PV Operations Lead, and the functional head. Plans are in place to expand our team of knowledgeable and conscientious pharmacovigilance professionals to support our growing portfolio. In your role as Senior Medical Director, Drug Safety & Pharmacovigilance, you will report directly to the Vice President, DSPV. #LI-KO2 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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Senior Medical Director, Drug Safety and Pharmacovigilance - Cambridge, United States - Intellia Therapeutics
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:
We are excited to welcome this new member to our growing team and company. This is both a strategic and hands-on role for a physician leader with broad experience in drug development and drug safety from biotech and/or pharmaceuticals. If you are a strong problem-solver, agile with regulations and requirements for global safety surveillance & safety risk management in drug development and post-marketing settings, 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:
