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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