Director, Clinical Development (Gene Therapy)
Encoded Therapeutics · Remote
Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.
Position details
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. The optimal candidate will have the desire to proactively participate within a cross-functional team of internal clinical, regulatory, scientific and operational colleagues and can interact with external experts, investigators, and government agencies.
The ideal candidate brings strong clinical trial governance, pharmacovigilance, and medical monitoring expertise to oversee our early-stage and advancing clinical programs. Because this role directly supports existing ongoing programs for both Dravet syndrome and chronic neuropathic pain, applicants will be strongly preferred if they have specific clinical development experience in gene therapies, rare diseases, neurological disease, and/or chronic pain management. Furthermore, the successful candidate will demonstrate a proven track record of building collaborative, operationally effective relationships with global key opinion leaders, trial investigators, patient advocacy groups, and regulatory bodies.
- 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.
The salary range for this position is 275,000 - 335,000
Encoded considers a variety of factors when determining base compensation, including experience, qualifications, internal equity and geographic location. Actual compensation will be determined based on relevant skills, experience, qualifications, internal equity, and business needs. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.
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
Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.
If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.