Program Manager - Gene Editing & Therapy

Job Summary

Responsible for the management of multiple clinical research studies and the direct hiring and supervision of Clinical Research Coordinators. Serves as the key liaison with the sponsor, IRB, core laboratories, site P.I.'s, as well as all levels of study staff. Will also coordinate trial initiation, patient recruitment, and expedite project approval and study start-up time.

Responsibilities

• Supervises operations of all study staff.
• Writes operations manuals.
• Participates in the formulation of policies and procedures for the study.
• Prepares Case Report Forms.
• Cohorts multi-center trials with NIH, FDA and Private foundations.
• Coordinates trial initiation, patient recruitment, and expedite project approval and study start-up time.
• Participates in developing and maintaining standard operating procedures for the projects.
• Coordinates with internal teams and external collaborators to design, implement, and analyze preclinical studies, including molecular, cellular, and in vivo experiments.
• Serves as the primary point of contact for communication between stakeholders, including scientific, operational, and regulatory teams.
• Ensures preclinical studies comply with GLP, GCP, and relevant regulatory standards.
• Prepares and reviews study protocols, reports, and other scientific documentation for internal and external submission.
• Serves as the primary point of contact for communication between stakeholders, including scientific, operational, and regulatory teams.
• Ensures preclinical studies comply with GLP, GCP, and relevant regulatory standards.
• Reports study progress at investigators' meetings.

  Qualifications

  • Proven experience in Preclinical Project Management, particularly in gene editing (e.g., CRISPR, ARCUS) or gene therapy programs.
  • Hands-on knowledge of molecular and cellular biology techniques, viral vector handling (AAV, Lentivirus), and in vivo models preferred.
  • Demonstrated ability to manage cross-functional teams and multiple projects simultaneously.
  • Experience with contracting and coordinating work with CROs and external collaborators.
  • Familiarity with regulatory requirements for preclinical studies supporting Investigational New Drug (IND) applications.
  • Strong analytical, problem-solving, and decision-making skills.
  • Excellent verbal and written communication skills, including scientific reporting and stakeholder presentations.
  • Proficient in project management software, Microsoft Office Suite, and data analysis tools.
  • Ability to work independently while fostering collaboration within multidisciplinary teams.
  • Strong organizational ability, attention to detail, and capability to prioritize tasks in a fast-paced, innovation-driven environment.
  • Proactive, self-motivated, and adaptable, with willingness to “roll up sleeves” and support experimental work as needed.
  • Excellent interpersonal skills, diplomacy, and cultural sensitivity to manage international collaboration.
  • Passion for advancing gene therapy and precision medicine to benefit patients.

    Additional Job Details

    • Remote Type: Onsite Work Location: 243-245 Charles Street
    • Scheduled Weekly Hours: 40
    • Employee Type: Regular
    • Work Shift: Day (United States of America)
    • Pay Range: $63,252.80 - $102,596.00/Annual
    • Grade: 7
    • EEO Statement: 5110 Massachusetts Eye and Ear Infirmary is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.
    • Mass General Brigham Competency Framework: At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.