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 also include participation in developing and maintaining standard operating procedures for the projects, developing advertising strategies to support recruitment activities, oversee budget management and subcontracts with associated institutions.

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• Supervises operations of all study staff.
• Writes operations manuals.
• Participates in the formulation of policies and procedures for the study.
• Prepares Case Report Forms.
• Coordinates multi‑center trials with NIH, FDA and private foundations.
• Reports study progress at investigators’ meetings.

Education: Bachelor’s Degree in a related field required;
Master’s Degree preferred. No experience in lieu of a degree.

Licenses and Credentials: None.

Experience – Research related: 5–7 years required.

Experience – Supervisory: 1–2 years preferred.

• Ability to make independent, effective decisions.
• Strong organizational and communication skills.
• Ability to effectively supervise and train staff.
• Strong database management and computer skills.
• Demonstrated analytical skills to problem‑solve effectively.
• Must possess strong budget‑management skills.

We are seeking an experienced Project Manager to lead and coordinate preclinical research programs in Gene Editing and Gene Therapy for genetic hearing loss. The ideal candidate will oversee cross‑functional teams, manage collaborations with external partners (CROs, academic institutions, and biotech companies), and ensure timely and compliant execution of preclinical projects that support early therapeutic development.

• Lead planning, execution, and oversight of preclinical gene editing and gene therapy projects, ensuring alignment with program objectives and timelines.
• Develop and maintain detailed project plans, including goals, milestones, resource, risk management, and budget tracking.
• Coordinate with internal teams and external collaborators to design, implement, and analyze preclinical studies, including molecular, cellular, and in‑vivo experiments.
• Serve as the primary point of contact for communication between stakeholders, including scientific, operational, and regulatory teams.
• Ensure preclinical studies comply with GLP, GCP, and relevant regulatory standards.
• Prepare and review study protocols, reports, and other scientific documentation for internal and external submission.
• Facilitate decision‑making by providing data‑driven insights, risk assessments, and project status updates.
• Monitor technological trends in gene editing/gene therapy and recommend innovative approaches to enhance project outcomes.
• Support business development efforts, including discussions with potential collaborators and partners.
• Represent the company at conferences, scientific presentations, and partner meetings as needed.

Education: Ph.D. in Gene Therapy, Molecular Biology, Genetics, Biochemistry, Immunology, or related life sciences; or equivalent experience in industry.

Experience: 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.

Skills: Strong analytical, problem‑solving, and decision‑making skills. Excellent verbal and written communication skills, including scientific reporting and…