[Hiring] Director, Clinical Development @Encoded Therapeutics

Role Description

Encoded is seeking a Director, Clinical Development who will provide clinical development support for multiple gene therapy programs across different stages of the drug development lifecycle.

• Provide clinical development support for ETX301 and pharmacovigilance and medical monitoring support for ETX101.
• Support investigator management and collaborate in regulatory interactions and patient advocacy outreach.
• Contribute subject matter expertise to content and publications.
• Participate within a cross-functional team of internal clinical, regulatory, scientific, and operational colleagues.
• Interact with external experts, investigators, and government agencies.

The ideal candidate brings strong clinical trial governance, pharmacovigilance, and medical monitoring expertise to oversee early-stage and advancing clinical programs.

• Support the clinical development strategy for programs targeting chronic neuropathic pain.
• Lead activities related to Phase 1-4 clinical trials (e.g., authoring and reviewing protocols, investigator brochures, and clinical study reports; CRO management).
• Define, plan, and provide dedicated medical monitoring support.
• Review adverse events, monitor real-time safety data, and prepare analyses for regulatory submissions.
• Serve as a clinical representative for Data Monitoring Committee (DMC) safety reviews.
• Work with the Eligibility Review Committee (ERC) to evaluate complex screening data.
• Build relationships with Key Opinion Leaders (KOLs), principal investigators, and patient advocacy organizations.
• Lead investigator meetings and site initiation visits.
• Define clear roles, responsibilities, and performance objectives for direct reports.

Qualifications

• MD, DO, or equivalent international medical degree required.
• 3+ years of clinical development experience in biotech/pharma for the Director level; 1+ year for the Associate Director level.
• Demonstrated experience designing and executing clinical trials.
• Ability to communicate efficiently with scientists, thought leaders, investigators, and executive management.
• Proven track record in medical monitoring and pharmacovigilance.
• Exceptional oral and written communication skills.
• Strong collaboration and personal interaction skills with internal stakeholders.
• Strong computer skills, including MS Office Suite and data analysis software.
• Ability to travel up to 25% for meetings and conferences.

Requirements

• Board certification or eligibility in relevant fields (e.g., Pain Medicine, Neurology, Medical Genetics).
• Specific experience in gene therapies, rare disease, epilepsy, and chronic pain management.
• Experience providing direct clinical input for regulatory submissions.
• Knowledge of AAV gene or cell therapy risks and safety evaluations.

Benefits

• Comprehensive benefits package, including competitive employer premium contributions.
• Meaningful stock option grants.
• PTO, sick time, and holiday pay.
• Generous Parental Leave program.
• Pre-tax medical and dependent care programs.
• STD, LTD, Life and AD&D.
• Professional development opportunities.
• Team-building events.
• Fully stocked micro-kitchen.
• Fitness center at South San Francisco location.