Founded in 2014 and based in Rockville, MD, NeoImmuneTech (NIT) is a clinical-stage T cell-focused biotech company dedicated to the discovery and development of novel immuno-therapeutics. At NIT, we strive to expand the therapeutic horizon in Immuno-Oncology and Infectious Diseases by greatly reducing the fatality and morbidity of life-threatening and debilitating diseases. Led by our scientific founder, who invented our lead asset NT-I7 (efineptakin alfa), we are science driven and patient focused. We believe that with NT-I7, the only clinical stage IL-7, we can enhance the body’s immune function to address key resistance mechanisms in Immuno-Oncology and deadly infectious diseases. We have a profound belief, rooted in our science, that we have the power to transform patient care with unique assets like NT-I7, and are committed to the pursuit of discovering their full potential in treating various diseases.
- Hybrid work opportunity
- Competitive pay
- Annual promotion opportunities
- 401(k) + company matching - 100% vests immediately!
- Free medical insurance
- Flexible Spending Account (FSA)
- Free life insurance
- Paid time off
- Paid holidays
- Paid sick leave
- Paid Family Medical Leave
- Free lunches, snacks, and drinks
- Cell phone reimbursement
- Internet reimbursement
Job Summary - Safety Scientist
The Safety/Pharmacovigilance Scientist provides oversight and monitoring of product safety regarding all programs, develops SOPs to ensure trials are conducted in compliance with regulatory requirements, and directs a team of risk and benefits management of study medication.
- Reviews all adverse events (AEs) and serious adverse events (SAEs) for accuracy and consistency, and coding and case assessments
- Independently applies scientific knowledge and performs literature searches
- Leads cross-functional training of relevant stakeholders
- Assists with the evaluation of case data to monitor and identify potential product trends and safety signals
- Performs periodical safety data review and reports and contributes to safety risk assessments
- Supports the drug safety-related regulatory documents (e.g., IB, DSUR, RMPs, SUSAR reports and CSR)
- Collaborates with team to assist in developing SOPs
- Partners with Quality Assurance and Regulatory Affairs to comply with applicable quality and regulatory requirements
- Works closely with internal clinical trial teams and external CROs to meet deadlines for data review and milestones
- Other duties as assigned
- BS in life sciences required; PharmD preferred
- 1-3 years of relevant experience in pharmacovigilance, drug safety, regulatory affairs, or clinical trials preferred
- Demonstrated experience in key activities and responsibilities for the role
- Working knowledge of relevant regulations
- Excellent written and verbal communication skills
- Korean language proficiency a plus
NeoImmuneTech, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
If you require assistance to complete a job application, please email us at firstname.lastname@example.org.