Director, Clinical Development (Gene Therapy)

Encoded Therapeutics

1d•$275,000 - $335,000•Onsite

About The Position

Encoded Therapeutics Inc. is a biotechnology company focused on advancing precision medicines for genetic disorders, utilizing genomics-driven discovery for viral gene therapy. The company aims to deliver life-changing treatments for individuals with genetic disorders that are not currently addressable by existing approaches. The Director, Clinical Development will provide crucial support for multiple gene therapy programs throughout their development lifecycle. This role involves supporting early-stage programs, providing pharmacovigilance and medical monitoring, collaborating on regulatory interactions and patient advocacy, and contributing subject matter expertise to content and publications. The ideal candidate will be a proactive team player, capable of interacting effectively with internal colleagues, external experts, investigators, and government agencies. Strong expertise in clinical trial governance, pharmacovigilance, and medical monitoring is essential for overseeing early-stage and advancing clinical programs. Experience in gene therapies, rare diseases, neurological disease, and/or chronic pain management is highly preferred, given the role's direct support for ongoing programs in Dravet syndrome and chronic neuropathic pain. The successful candidate will have a proven ability to build collaborative relationships with global key opinion leaders, trial investigators, patient advocacy groups, and regulatory bodies.

Requirements

MD, DO, or equivalent international medical degree required.
3+ years of clinical development experience in biotech/pharma required for the Director level.
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.
For the Director level, demonstrated experience managing direct reports, leading cross-functional project teams, and building collaborative relationships with key opinion leaders.
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.

Nice To Haves

Applicants will be strongly preferred if they have specific clinical development experience in gene therapies, rare diseases, neurological disease, and/or chronic pain management.
Experience overseeing protocol-mandated prophylactic immunomodulation regimens (e.g., glucocorticoids) to mitigate immune-mediated responses is highly desirable.
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.

Responsibilities

Support the clinical development strategy for programs targeting chronic neuropathic pain in partnership with senior Clinical Development leadership.
Lead activities related to Phase 1-4 clinical trials, including authoring and reviewing protocols, investigator brochures, and clinical study reports, as well as CRO management.
Define, plan, and provide dedicated medical monitoring support, evaluating participant eligibility, safety, and efficacy for ongoing and completed studies in 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 a clinical representative for Data Monitoring Committee (DMC) safety reviews, evaluating potential dose-limiting toxicities and ensuring continuous safety monitoring.
Work with the Eligibility Review Committee (ERC) to evaluate complex screening data and confirm participant eligibility criteria.
Build and cultivate relationships with Key Opinion Leaders (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.
For direct reports, define clear roles, responsibilities, and performance objectives, provide constructive feedback, and identify growth opportunities.

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