Director of Gene Therapy Clinical Development

Encoded Therapeutics Inc.; United States; Presencial; USD 275 000 - 335 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Benefits package

Resumo da oferta

Encoded Therapeutics Inc. in the United States seeks a Director, Clinical Development to support multiple gene therapy programs across the drug development lifecycle.

You will work with senior leadership to guide ETX301 and provide pharmacovigilance and medical monitoring for ETX101, while engaging regulatory bodies and patient advocacy groups. The role requires governance, pharmacovigilance, and medical monitoring expertise, with preference for experience in gene therapies, rare diseases,

Qualificações

• MD/DO or international equivalent required.
• Proven clinical trial design and execution experience.
• Strong vendor management and regulatory liaison abilities.
• Excellent written and verbal communication with stakeholders.

Responsabilidades

• Provide clinical development support for gene therapy programs across stages.
• LeadPhase 1-4 clinical trials; author and review protocols and reports; manage CROs.
• Define medical monitoring plans and evaluate safety across studies.
• Oversee pharmacovigilance activities and regulatory submissions input.
• Serve as clinical rep for DMC safety reviews and dose-limiting toxicity assessments.
• Collaborate with ERC, investigators, KOLs, patient advocacy groups, and regulators.
• Lead site initiation visits and investigator meetings; mentor direct reports.

Conhecimentos

Clinical governance

Pharmacovigilance

Medical monitoring

Vendor management

Regulatory interactions

Leadership

Cross-functional collaboration

Excellent communication

Formação académica

MD/DO or international equivalent

Ferramentas

RAVE

InForm

EDA tools

Statistical software

Descrição da oferta de emprego

Encoded Therapeutics Inc. in the United States seeks a Director, Clinical Development to support multiple gene therapy programs across the drug development lifecycle.

You will work with senior leadership to guide ETX301 and provide pharmacovigilance and medical monitoring for ETX101, while engaging regulatory bodies and patient advocacy groups. The role requires governance, pharmacovigilance, and medical monitoring expertise, with preference for experience in gene therapies, rare diseases,