Director, Clinical Development – Gene Therapy

Encoded Therapeutics Inc.

. Provide clinical development support for multiple gene therapy programs across different stages of the drug development lifecycle .

Posted 10/8/2026full-timeRemote • United StatesLead💰 $275,000 - $335,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical development and medical monitoring for gene therapy programs, with a strong focus on regulatory compliance, pharmacovigilance, and effective communication with stakeholders. Proven ability to lead clinical trials and manage cross-functional teams while ensuring patient safety and data integrity.

Highest-signal resume keywords

Clinical Development ExperienceMedical MonitoringPharmacovigilanceRegulatory ComplianceVendor Management

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial DesignProtocol AuthoringData InterpretationAdverse Event ReviewEligibility Confirmation

Soft Skills

Effective CommunicationCollaborationRelationship BuildingLeadershipFeedback Provision

Tools & Technologies

MS Office SuiteElectronic Data Capture SystemsData Analysis SoftwareRAVEInForm

Certifications & Qualifications

MDDOBoard Certification in Medical Specialties

Industry Keywords

Gene TherapyChronic Neuropathic PainDravet SyndromeClinical TrialsGCP/ICH Compliance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide clinical development support for multiple gene therapy programs across different stages of the drug development lifecycle
Support clinical development for ETX301 and pharmacovigilance and medical monitoring for ETX101
Support investigator management and collaborate in regulatory interactions and patient advocacy outreach
Contribute subject matter expertise to content and publications
Support clinical development strategy for programs targeting chronic neuropathic pain
Lead activities related to Phase 1–4 clinical trials, including authoring and reviewing protocols, investigator brochures, and clinical study reports, and managing CROs
Define, plan, and provide medical monitoring support across ongoing and completed studies for Dravet syndrome and chronic neuropathic pain
Review adverse events, monitor real-time safety data, prepare analyses and clinical input for regulatory submissions, and lead data interpretation with pharmacovigilance CRO partners
Serve as clinical representative for Data Monitoring Committee safety reviews and ensure continuous safety monitoring
Evaluate complex screening data and confirm participant eligibility with the Eligibility Review Committee
Build relationships with KOLs, principal investigators, pediatric clinical trial networks, outcomes experts, and patient advocacy organizations
Lead investigator meetings and site initiation visits and partner with Clinical Operations and Medical Affairs to drive enrollment
Define roles, responsibilities, and performance objectives for direct reports; provide feedback and identify growth opportunities
Collaborate with internal clinical, regulatory, scientific, and operational colleagues and external experts, investigators, and government agencies

Requirements

What you’ll need

MD, DO, or equivalent international medical degree required
3+ years of clinical development experience in biotech/pharma required for the Director level
Equivalent academic physician-scientist experience leading clinical trials as a principal investigator will also be considered
Demonstrated experience designing and executing clinical trials, including strong vendor management skills
Ability to communicate efficiently with scientists, thought leaders, investigators, and executive management
Proven track record in medical monitoring, evaluating potential dose-limiting toxicities, pharmacovigilance, and GCP/ICH regulatory compliance
Experience overseeing protocol-mandated prophylactic immunomodulation regimens is highly desirable
Experience managing direct reports, leading cross-functional project teams, and building collaborative relationships with key opinion leaders
Exceptional oral and written communication skills, including translating complex clinical data into presentations, regulatory documents, and peer-reviewed publications
Strong collaboration and personal interaction skills with internal stakeholders across Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics, Research, and Translational Science
Strong computer skills, including MS Office Suite, electronic data capture systems such as RAVE and InForm, data analysis software, and data presentation
Ability to travel up to 25%, including possible international travel
Board certification or eligibility in specified medical specialties preferred
Specific experience in gene therapies, rare disease, epilepsy, chronic pain management, medical monitoring, and pharmacovigilance preferred
Experience with clinical-regulatory strategies and/or industry-academic collaborations preferred
Experience providing clinical input for regulatory submissions and engaging with global health authorities preferred
Knowledge of AAV gene or cell therapy risks, immunogenicity, dorsal root ganglionopathy, hepatotoxicity, and long-term follow-up requirements preferred

Benefits

Comp & perks

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
Discretionary annual bonus
Discretionary stock-based long-term incentives