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

• 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

Responsibilities

• Works closely with senior leaders to develop and execute clinical development strategies including, but not limited to, clinical pipelines and competitive development in Immuno-Oncology and beyond
• Responsible for integrating clinical development objectives with global considerations into strategic business decisions
• Provides oversight of all aspects of clinical development and the management of resources to ensure study milestones and deliverables are timely achieved
• Leads and directs Safety/Pharmacovigilance, Medical Writing, Data Management, and Statistics Teams
• Serves as the Clinical Development point-of-contact for medical monitor inquiries from clinical operations, clinical research organizations (CROs), and collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
  
• Ensures all clinical development programs and projects are conducted in accordance with applicable SOPS, ICH, GCP and other regulatory requirements
• Develops departmental SOPs, regulatory related documents, and collaborates with Clinical Operations, Quality Assurance, and Regulatory Affairs for compliance with applicable quality and regulatory requirements
• Contributes to Clinical Development functional organization by managing the talent strategies, operational excellence and efficiencies, and by driving key innovation initiatives
• Provides input on the design of preclinical studies supporting clinical strategy
• Has responsibility for defining late-stage development approaches for licensing/Business Development activities

Qualifications

• Medical Degree (MD) required; PhD is ideal
• 10+ years of industry experience required
• Experience in the Oncology or Immuno-Oncology therapeutic area required
• Demonstrated ability to lead the development of project strategy and be accountable for project plans, timelines, progress, and outcomes
• Demonstrated ability to lead, coach, and mentor junior physicians/scientists
• Excellent working knowledge of ICH, GCP and FDA/EMA guidelines/regulations
• Excellent leadership, management, and negotiation skills
• Excellent verbal and written communication skills
• Solid understanding of the drug development process with an emphasis on clinical development
• Approximately 10% travel may be required

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.

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