Executive Director, Head of Clinical Operations

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
  

Job Summary

The Executive Director of Clinical Operations leads a team of operations professionals and is responsible for executing the clinical development strategy and associated operational deliverables of global clinical trials (phase 1- 3, and post-marketing).

Responsibilities 

• Provides leadership by driving organizational and division clinical operation strategies and ensures strategic operational planning, optimal trial resource allocation (including consultants and vendor partners), as well as high quality execution of clinical trials around the globe within agreed clinical program timelines and budget
• Oversees the operational strategic prioritization of activities and deliverables, in accordance with overall corporate and development objectives, goals, and timelines
• Successfully collaborates across the organization including Regulatory Affairs, Quality Assurance, Business, Finance, Legal, and HR as well as external partners and others
• Ensures all clinical programs are conducted in accordance with applicable SOPS, ICH, GCP, and other regulatory requirements
• Provides hands-on expertise in conducting protocol/protocol amendment development and oversight
• Leads the selection and management of CROs and other external vendors and develops and maintains strong partnerships; ensures trial compliance to SOPs, protocols, management plans, and budget
• Coordinates with translational research to deliver high quality data deliverables on time and on budget
• Provides support for regulatory submissions and dossier development for interactions with FDA, EMA, and other regulatory agencies
• Responsible for overseeing development of SOPs and works with Quality Assurance for compliance with quality and regulatory requirements
• Provides direction and mentorship to staff including setting goals that are aligned with organizational and division goals
• Approximately 10% travel may be required (not applicable during the COVID-19 pandemic)
  

Qualifications

• Master’s degree in medical-related or life science field; PhD preferred
• 15+ years related experience
• Expertise in the areas of drug development, operations, and strategic planning, specifically management of clinical trial operations
• Experience working in Oncology or Immuno-Oncology therapeutic area
• Extensive experience in clinical operations methods and processes and managing CROs and other clinical study vendors
• Proven track record of oversight, coordination, and resource management of multiple global clinical operations deliverables to time, quality, and budget
• Extensive experience in GCP Compliance with a strong understanding of FDA regulations; EU Clinical Trials Directive, GCP, and/ SOPs in pharmaceutical or biotech
• Solid understanding of the drug development process with a special emphasis on clinical operations
• Demonstrated and effective leadership skills and proven ability to foster team productivity and cohesiveness
• Demonstrated experience managing and mentoring clinical team members
• Excellent verbal and written communication skills
• Strong problem resolution and conflict management skills

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.

#LI-hybrid