Strategic Leader, Gene Therapy Clinical Development

Encoded Therapeutics; United States; Remote; USD 275,000 - 335,000; Full time

Benefits offered by this job

Comprehensive benefits package

Stock option grants

PTO, sick time and holidays

Parental Leave program

Pre-tax medical and dependent care

Job summary

Encoded Therapeutics Inc. seeks a Director, Clinical Development to lead clinical development support for multiple gene therapy programs across the drug development lifecycle.

You will partner with senior Clinical Development leadership to shape strategy, governance, and cross‑functional execution for Dravet syndrome and chronic neuropathic pain programs. The role requires an MD/DO, 3+ years in biotech at director level, expertise in medical monitoring, pharmacovigilance, and regulatory

Qualifications

• MD/DO or equivalent medical degree required.
• 3+ years of clinical development experience at director level in biotech/pharma.
• Experience designing and executing clinical trials with vendor management.
• Strong communication with scientists, investigators, and executives.
• Proven record in medical monitoring, pharmacovigilance, and regulatory compliance.
• Experience with regulatory submissions and collaboration with health authorities.

Responsibilities

• Lead clinical development strategy with senior leadership for programs targeting chronic neuropathic pain.
• Oversee Phase 1–4 trial design, protocols, investigator brochures, and study reports.
• Provide dedicated medical monitoring across studies for gene therapy programs.
• Review adverse events and lead data analyses for regulatory submissions.
• Represent DMC safety reviews and ensure ongoing safety governance.
• Collaborate with ERC on eligibility criteria and site/investigator leadership.
• Build relationships with KOLs, investigators, and patient advocacy groups.
• Mentor junior staff and lead cross-functional project teams.

Skills

Clinical development

GCP/ICH regulatory

Medical monitoring

Pharmacovigilance

Vendor management

Cross-functional leadership

Regulatory submissions

Data interpretation

Team leadership

Education

MD/DO or equivalent

Tools

MS Office

RAVE

InForm

Data analysis software

Job description

Encoded Therapeutics Inc. seeks a Director, Clinical Development to lead clinical development support for multiple gene therapy programs across the drug development lifecycle.

You will partner with senior Clinical Development leadership to shape strategy, governance, and cross‑functional execution for Dravet syndrome and chronic neuropathic pain programs. The role requires an MD/DO, 3+ years in biotech at director level, expertise in medical monitoring, pharmacovigilance, and regulatory