Director, Gene Therapy Clinical Development

Encoded Therapeutics, Inc.; Northern (KY); On-site; USD 275,000 - 335,000; Full time

Benefits offered by this job

Healthcare benefits

PTO & holidays

Parental Leave

Pre-tax benefits

Disability & Life Insurance

Team-building events

On-site perks

Fitness center

Job summary

Encoded Therapeutics Inc. is seeking a Director, Clinical Development to support gene-therapy programs across the drug development lifecycle in the United States.

This role crosses clinical development, regulatory interactions, and patient advocacy while collaborating with global experts. The ideal candidate has strong clinical trial governance, pharmacovigilance and medical monitoring expertise, with experience in gene therapies and rare diseases.

Qualifications

• MD, DO, or equivalent international medical degree required.
• 3+ years of clinical development experience at Director level.
• Demonstrated experience designing and executing clinical trials with vendor management.
• Excellent communication with scientists, investigators and executives.
• Proven track record in pharmacovigilance, medical monitoring, and GCP/ICH compliance.
• Willingness to travel up to 25% for meetings and conferences.

Responsibilities

• Clinical Strategy – support the clinical development strategy for programs targeting chronic neuropathic pain.
• Trial Design and Execution – lead Phase 1-4 trials, including protocols, brochures, and study reports.
• Medical Monitoring – plan and provide medical monitoring across studies for Dravet syndrome and chronic pain.
• Pharmacovigilance & Data Analysis – review adverse events and support regulatory submissions with data interpretation.
• DMC & Safety Governance – act as clinical representative for DMC safety reviews.
• Eligibility Review – work with ERC to evaluate complex screening data and eligibility criteria.
• Stakeholder & KOL Engagement – build relationships with investigators, KOLs, patient groups, regulators.
• Site & Investigator Leadership – lead investigator meetings and site initiation visits.
• Team Leadership – manage direct reports, set objectives, and foster growth.

Skills

Clinical governance

Pharmacovigilance

Medical monitoring

Vendor management

Communication skills

Team leadership

Cross-functional collaboration

Data interpretation

Regulatory submissions input

Education

MD/DO or equivalent

Tools

MS Office Suite

RAVE / InForm

Data analysis software

Job description

Encoded Therapeutics Inc. is seeking a Director, Clinical Development to support gene-therapy programs across the drug development lifecycle in the United States.

This role crosses clinical development, regulatory interactions, and patient advocacy while collaborating with global experts. The ideal candidate has strong clinical trial governance, pharmacovigilance and medical monitoring expertise, with experience in gene therapies and rare diseases.