Senior Director, Clinical Regulatory Affairs (Cell & Gene Therapy)

Location: Remote within the United States, or based in Louisville, Colorado or Seattle, Washington. Approximately 20% travel is required, including possible international travel.

Salary: $253,000–$312,500 annual salary for the Senior Director level. An Executive Director level may be considered, with a salary range of $272,900–$337,000.

Company

hirify.global is a biotechnology company developing integrated immunotherapy and off-the-shelf cell and gene therapies for cancer and other serious diseases.

What you will do

• Lead regulatory strategy and oversight for ongoing and planned in vivo CAR-T therapy programs.
• Develop global strategies for indication selection, clinical trial design, endpoints, registration, and product labeling.
• Lead IND, CTA, BLA, and MAA submissions and serve as the primary contact for global regulatory agencies.
• Prepare and review nonclinical and clinical modules, health authority responses, briefing packages, and meeting materials.
• Communicate regulatory risks, mitigations, and recommendations to program teams, senior management, and external stakeholders.
• Collaborate with translational medicine, preclinical, clinical, CMC Regulatory, technical, and external partner teams while mentoring colleagues.

Requirements

• Relevant scientific degree: PhD, MS, or BS.
• At least 12, 15, or 15+ years of regulatory affairs experience for the Senior Director level, depending on degree; higher experience thresholds apply for the Executive Director level.
• Demonstrated expertise in cell and gene therapy, preferably CAR-T or T-cell engaging modalities.
• Strong knowledge of global regulatory requirements for early- and late-stage gene and cell therapy development.
• Experience in oncology, hematology, or a related specialty, with a successful record of regulatory submissions and approvals.
• Proven ability to interact with regulatory authorities and collaborate effectively across multidisciplinary teams.

Nice to have

• Experience in in vivo gene delivery.
• Experience in oncology, hematology, or related therapeutic areas.

Culture & Benefits

• Medical, dental, and vision insurance plans.
• 401(k) plan with a 100% company match on the first 4% of employee deferral.
• Paid time off and commuter benefits.
• Cell phone stipend.
• Work in newly established facilities in Seattle and Louisville alongside multidisciplinary drug development teams.