Director, Gene Therapy Clinical Development

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

Benefits offered by this job

Comprehensive benefits package

Stock options

PTO, sick time, holidays

Parental leave

Pre-tax benefits

STD/LTD/Life/AD&D

Professional development

Team-building events

Fitness center at South San Francisco

Job summary

Encoded Therapeutics Inc. seeks a Director, Clinical Development to provide governance and medical monitoring across gene therapy programs from early to late stages. You will collaborate with clinical, regulatory and operations teams and engage with investigators, KOLs, and patient advocacy groups.

The role emphasizes pharmacovigilance, data review, and regulatory input for Dravet syndrome and chronic neuropathic pain programs, with leadership responsibilities and cross-functional oversight.

Qualifications

• MD/DO or international medical degree required.
• 3+ years of clinical development experience for Director, 1+ year for Associate Director.
• Experience designing and executing clinical trials; vendor management skills.
• Strong communication with scientists, investigators and management.

Responsibilities

• Support clinical development strategy for pain programs.
• Lead Phase 1-4 trial activities and documentation (protocols, brochures, reports).
• Provide medical monitoring across studies and support safety assessments.
• Lead pharmacovigilance data review and regulatory input.
• Represent DMC safety reviews and oversee safety monitoring across portfolio.
• Engage with ERC for complex screening data and eligibility.
• Build relationships with KOLs, investigators, patient groups, regulators.
• Lead site initiation, investigator meetings, and cross-functional collaboration.

Skills

Clinical governance

Pharmacovigilance

Medical monitoring

Regulatory interactions

GCP/ICH compliance

Trial design & execution

Cross-functional collaboration

Team leadership

Education

MD/DO or international equivalent

Board certification or eligibility in Pain Medicine, Neurology, Genetics, PM&R, Psychiatry

Tools

MS Office

RAVE

InForm

Data analysis software

Job description

Encoded Therapeutics Inc. seeks a Director, Clinical Development to provide governance and medical monitoring across gene therapy programs from early to late stages. You will collaborate with clinical, regulatory and operations teams and engage with investigators, KOLs, and patient advocacy groups.

The role emphasizes pharmacovigilance, data review, and regulatory input for Dravet syndrome and chronic neuropathic pain programs, with leadership responsibilities and cross-functional oversight.