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 long-acting human 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

• Leads and manages large, complex trials and/or multiple smaller trials to deliver positive patient and investigator site experiences and high quality data
• Partners with other organizations to oversee and actively participate in Site Initiation Visits (SIVs), Investigator Calls and Investigator Meetings
• Responsible for enrollment strategy
• Responsible for trial documentation and ensuring inspection readiness of respective clinical trial(s) at all times. This includes timely documentation of deviations, creation of storyboards or issue summary documents (e.g. for high risk areas/hot topics)
• Leads vendor relations, (including CRO) qualification process, selection, and oversight
• Applies expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Company standards of operation in the conduct of clinical trials
• Works closely with Clinical Scientist/Clinical Lead and other cross-functional team members to develop study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR), etc.
• Responsible for data management and clinical operations teams in review of clinical data including providing guidance on issues and queries and implementing risk management concepts, as needed
• Responsible for TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory document/packages
• Conducts sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as needed
• Creates, manages, and reports timelines for milestones and deliverables

Qualifications

• Experience in management of Oncology trials or pediatric trials preferred
• Able to travel domestically (~ 5% or less, not applicable during COVID-19 pandemic)

• Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
• At least 3 years previous experience in study coordination (e.g., study site) or study management (e.g., CRO or sponsor)
• Fluency in study phases and demonstrable knowledge of how they apply to clinical development
• Strong working knowledge of ICH Good Clinical Practice guidelines
• Working knowledge of project management concepts (e.g., scope, resources, timeline, risk management)
• Able to handle multiple tasks and deadlines
• Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
• Able to identify issues and take appropriate actions
• Highly effective verbal and written communication skills
• Experience using computer applications including spreadsheets, email, word-processing software and web-based systems

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-us@neoimmunetech.com.

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