Director, Gene Therapy Clinical Development

Encoded-Therapeutics,-Inc.; South San Francisco (CA); On-site; USD 275,000 - 335,000; Full time

Benefits offered by this job

Stock options

Paid time off (PTO)

Parental Leave

Medical benefits

Job summary

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

The role includes pharmacovigilance and medical monitoring for ETX101, and clinical development for ETX301, with cross-functional collaboration across regulatory, scientific, and operational teams. The ideal candidate will have strong governance and trial design experience in gene therapies or rare neurological diseases, and a proven track record

Qualifications

• MD, DO, or equivalent international medical degree required.
• 3+ years of clinical development experience in biotech/pharma at Director level.
• Proven ability designing and executing clinical trials with vendor management.
• Strong communication with scientists, investigators and leadership.
• Experience in medical monitoring, pharmacovigilance, and GCP/ICH compliance.
• Experience mentoring and leading cross-functional teams.

Responsibilities

• Clinical Strategy - support development strategy for chronic neuropathic pain programs.
• Trial Design and Execution - lead Phase 1-4 trials, author protocols and CSRs, manage CROs.
• Medical Monitoring - evaluate eligibility, safety and efficacy across studies.
• Pharmacovigilance & Data Analysis - review AEs, monitor safety data, support regulatory submissions.
• DMC & Safety Governance - act as clinical representative for DMC reviews.
• Eligibility Review - evaluate screening data and eligibility criteria.
• Stakeholder & KOL Engagement - build relationships with investigators and patient groups.
• Site & Investigator Leadership - lead meetings and initiate sites; partner with Clinical Ops.
• Team Leadership - define roles, provide feedback, and support growth.

Skills

Clinical development

Medical monitoring

Pharmacovigilance

Trial design

DMC governance

KOL engagement

Team leadership

Regulatory communication

Vendor management

Data analysis

MS Office

EDC systems (RAVE, InForm)

Travel coordination

Education

MD/DO or equivalent medical degree

Tools

RAVE

InForm

Job description

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

The role includes pharmacovigilance and medical monitoring for ETX101, and clinical development for ETX301, with cross-functional collaboration across regulatory, scientific, and operational teams. The ideal candidate will have strong governance and trial design experience in gene therapies or rare neurological diseases, and a proven track record