Director, Clinical Development (Gene Therapy)

Encoded Therapeutics

Any City, USRemotePosted 24 days ago$275,000 - $335,000

Full TimeDirector & AboveClinical DevelopmentBiotechnology

Summary

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. Reporting to senior leadership within Clinical Development, the role will initially be responsible for providing clinical development support for ETX301 and pharmacovigilance and medical monitoring support for ETX101. The role will also support investigator management and will collaborate in regulatory interactions, patient advocacy outreach, and will contribute subject matter expertise to content and publications.

Job description

Responsibilities

Clinical Strategy: In partnership with senior Clinical Development leadership, support the clinical development strategy for programs targeting chronic neuropathic pain.
Trial Design and Execution: Lead activities related to Phase 1-4 clinical trials to deliver on the strategic vision and address patient needs (e.g., authoring and reviewing protocols, investigator brochures, and clinical study reports; CRO management).
Medical Monitoring: Define, plan, and provide dedicated medical monitoring support, including the evaluation of participant eligibility, safety, and efficacy across ongoing and completed studies for Dravet syndrome and chronic neuropathic pain.
Pharmacovigilance & Data Analysis: Review adverse events, monitor real-time safety data, prepare analyses and clinical input for regulatory submissions, and lead data interpretation in partnership with pharmacovigilance CRO partners.
DMC & Safety Governance: Serve as a clinical representative for Data Monitoring Committee (DMC) safety reviews, evaluating potential dose-limiting toxicities and ensuring continuous safety monitoring across the clinical portfolio.
Eligibility Review: Work with the Eligibility Review Committee (ERC) to evaluate complex screening data and confirm participant eligibility criteria across ongoing clinical programs.
Stakeholder & KOL Engagement: Build and cultivate relationships with Key Opinion Leaders (KOLs), principal investigators, pediatric clinical trial networks, outcomes experts, and patient advocacy organizations to inform trial endpoints and enhance patient recruitment.
Site & Investigator Leadership: Lead investigator meetings and site initiation visits; partner with Clinical Operations and Medical Affairs to drive enrollment into the clinical studies.
Team Leadership: For direct reports, define clear roles, responsibilities, and performance objectives to ensure alignment with clinical development goals. Provide supportive, constructive feedback, celebrate achievements, and identify opportunities for growth and improvement.

Requirements

MD, DO, or equivalent international medical degree required.
3+ years of clinical development experience in biotech/pharma is required for the Director level, while 1+ year of clinical development experience will be considered for the Associate 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 is required at the Director level.
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 (e.g., glucocorticoids) to mitigate immune-mediated responses is highly desirable.
For the Director level, demonstrated experience managing direct reports, leading cross-functional project teams, and building collaborative relationships with key opinion leaders.
For the Associate Director level, a demonstrated readiness to mentor junior staff and effectively coordinate across clinical and operational functions.
Exceptional oral and written communication skills, with a track record of translating complex clinical data into impactful presentations, regulatory documents, and peer-reviewed publications.
Strong collaboration and personal interaction skills with all levels of internal stakeholders, including Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics, Research, and Translational Science.
Strong computer skills, including MS Office Suite, use of industry-standard electronic data capture systems (e.g., RAVE, InForm), and proficiency in data analysis software and data presentation.
Ability to travel up to 25% for investigator meetings, site visits, medical conferences, and regulatory meetings, which could include international travel.

Preferred Qualifications

Board certification or eligibility in Pain Medicine, Pediatric or Adult Neurology, Medical Genetics, Physical Medicine & Rehabilitation, Psychiatry, or related fields.
Specific experience in gene therapies, rare disease, epilepsy, chronic pain management, medical monitoring, and pharmacovigilance.
A strong track record in team leadership, development of clinical-regulatory strategies, and/or industry-academic collaborations.
Experience providing direct clinical input for regulatory submissions and participating in engagement with global health authorities (FDA, EMA).
Knowledge of the nuances and class-specific risks in AAV gene or cell therapy, including managing immunogenicity, safety evaluations for dorsal root ganglionopathy or hepatotoxicity, and executing long-term (e.g., 5-year) follow-up requirements.

Requirements

MD, DO, or equivalent international medical degree required.
3+ years of clinical development experience in biotech/pharma is required for the Director level, while 1+ year of clinical development experience will be considered for the Associate 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 is required at the Director level.
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 (e.g., glucocorticoids) to mitigate immune-mediated responses is highly desirable.
For the Director level, demonstrated experience managing direct reports, leading cross-functional project teams, and building collaborative relationships with key opinion leaders.
For the Associate Director level, a demonstrated readiness to mentor junior staff and effectively coordinate across clinical and operational functions.
Exceptional oral and written communication skills, with a track record of translating complex clinical data into impactful presentations, regulatory documents, and peer-reviewed publications.
Strong collaboration and personal interaction skills with all levels of internal stakeholders, including Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics, Research, and Translational Science.
Strong computer skills, including MS Office Suite, use of industry-standard electronic data capture systems (e.g., RAVE, InForm), and proficiency in data analysis software and data presentation.
Ability to travel up to 25% for investigator meetings, site visits, medical conferences, and regulatory meetings, which could include international travel.
Board certification or eligibility in Pain Medicine, Pediatric or Adult Neurology, Medical Genetics, Physical Medicine & Rehabilitation, Psychiatry, or related fields.
Specific experience in gene therapies, rare disease, epilepsy, chronic pain management, medical monitoring, and pharmacovigilance.
A strong track record in team leadership, development of clinical-regulatory strategies, and/or industry-academic collaborations.
Experience providing direct clinical input for regulatory submissions and participating in engagement with global health authorities (FDA, EMA).
Knowledge of the nuances and class-specific risks in AAV gene or cell therapy, including managing immunogenicity, safety evaluations for dorsal root ganglionopathy or hepatotoxicity, and executing long-term (e.g., 5-year) follow-up requirements.

Benefits

Annual Bonus Eligibility
Stock-Based Long-Term Incentives
Competitive Employer Health Premium Contributions
Stock Option Grants
Paid Time Off
Sick Time
Holiday Pay
Parental Leave
Pre-Tax Medical and Dependent Care Programs
Short-Term Disability Insurance
Long-Term Disability Insurance
Life Insurance
Accidental Death and Dismemberment Insurance
Professional Development Opportunities
Team-Building Events
On-Site Fitness Center
Stocked Micro-Kitchen

Company overview

Encoded Therapeutics is a clinical-stage biotechnology company pioneering precision genetic medicines for severe central nervous system (CNS) disorders. Founded in 2014 and headquartered in South San Francisco, California, the company is developing potentially disease-modifying gene therapies for pediatric CNS conditions using its proprietary vector engineering platform. Encoded's innovative approach combines novel regulatory elements and payloads with AAV vectors to achieve unprecedented gene specificity and cell selectivity, enabling targeted expression of therapeutic transgenes in specific cell types. The company's flagship program, ETX101, targets Dravet syndrome and has received RMAT designation from the FDA. Encoded's pipeline also includes programs for Angelman syndrome, Lennox-Gastaut syndrome, STXBP1-related disorders, Alzheimer's disease, and neuropathic pain. With a team of 51-200 employees and significant venture backing including a $135 million Series D round, Encoded is advancing potentially transformative one-time gene therapies that could address significant unmet medical needs in neurological disorders.