AD / Director of Drug Safety

Our Company

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.

We Offer

• Remote and hybrid work opportunities
• Competitive pay
• Annual promotion opportunities
• 401(k) + company matching - 100% vests immediately!
  
• Free medical insurance
• 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

The AD / Director of Drug Safety / Pharmacovigilance is responsible for all activities related to patient safety, pharmacovigilance, signal detection, and medical monitoring. He/she will ensure the consistency and accuracy of adverse event reporting in clinical studies including initial safety review of adverse events, interaction with drug safety vendors, review of source documents, and preparation of documents for submission to regulatory authorities.

Primary Responsibilities 

• Plans, manages, and monitors Safety / PV activities for study medications, including:
        Oversees CRO medical monitor or directly monitors study safety-related activities
        Establishes safety analyses in clinical trials and safety databases for monitoring
        Responsible for medical coding review, safety issue management, and Adverse Events (AEs) and Serious Adverse Events (SAEs) reviews and reports
        Oversees safety aspects of regulatory submissions, such as annual reports, updating of the IB, and final study reports
• Develops proactive patient-centric risk management strategies
• Responsible for risk-benefit and product risk minimization of activities for investigational compounds of Clinical Program
• Provides interpretation of clinical trial safety data for clinical trial reports, publications, and submission documents
• Responsible for drug safety-related regulatory documents (e.g., IB, DSUR, RMPs, SUSARs report, Clinical Overview Statements)
• Maintains current knowledge of all applicable drug safety guidelines and regulations (e.g., FDA)
• Develops departmental SOPs and works with Quality Assurance for compliance with applicable quality and regulatory requirements
• Serves as a drug safety expert and provides updates of the drug’s safety profile to senior leadership
• Leads internal Safety / PV monthly review meetings
• Other duties as assigned

Qualifications

• MD required
• 7-10 years of experience in Pharmacovigilance and Risk Management in pharmaceutical or biopharma
• Experience in Oncology or Immuno-Oncology therapeutic area preferred
• Knowledge of medical and therapeutic terminology
• Demonstrates excellent leadership and project management competencies
• Working knowledge of ICH, GCP, and FDA/EMA safety regulations
• Excellent written and verbal communication skills
• Approximately 10% travel may be required (not applicable during the COVID-19 pandemic)

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 hr@neoimmunetech.com.