Director, Gene Therapy Clinical Science
Rocket Pharmaceuticals
August 23, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Position Summary
- Support, guide, and implement clinical development strategy and plans for First in Human gene therapy programs.
- Lead, develop, and manage clinical studies; maintain relationships with investigators and key opinion leaders.
- Ensure medical/scientific integrity and patient wellbeing; maintain compliance with internal/external standards and mitigate clinical/medical risks.
Responsibilities
- Lead the clinical science team (assign resources, coach, delegate, and guide).
- Provide oversight for clinical studies: planning, execution, completion, and reporting.
- Provide clinical/medical input for protocol, Informed Consent Form, and Investigator Brochure; lead protocol amendments and related documents.
- Provide clinical/medical input for data collection tools (e.g., EDC databases).
- Oversee review/analysis of clinical data and generation of study reports, publications, and clinical-regulatory documents.
- Draft and follow safety and data review plans; review patient and cumulative safety data.
- Draft clinical and safety sections of critical documents.
- Prepare/conduct presentations; support publications, abstracts, and presentations.
- Partner cross-functionally (basic research, translational science, clinical operations, regulatory, manufacturing, medical affairs, project management) to ensure GCP/quality execution.
- Help establish DMCs and endpoint adjudication committees; oversee charters, presentations, and outcomes documentation.
- Serve as key contact for clinical/medical protocol questions.
- Represent science function at meetings; provide scientific input at advisory boards and congresses.
- Review and manage protocol deviations.
- May support responses to regulatory queries, audit/inspection findings, and CTAs.
- Contribute to continuous improvement to maximize trial execution effectiveness.
Qualifications
- Nursing degree required; MSN with 10+ years or BSN with 12+ years progressive clinical research drug development experience (cell or gene therapy preferred).
- Knowledge of clinical development; global/regional regulation; ICH/GCP; adverse event management; clinical data review.
- Ability to collaborate on multi-functional drug development teams.
- Self-motivated, highly organized, detail-oriented, able to multi-task.
- Excellent oral/written communication and interpersonal skills; ability to influence and work cross-culturally/cross-functionally.
- Support, guide, and implement clinical development strategy and plans for First in Human gene therapy programs.
- Lead, develop, and manage clinical studies; maintain relationships with investigators and key opinion leaders.
- Ensure medical/scientific integrity and patient wellbeing; maintain compliance with internal/external standards and mitigate clinical/medical risks.
Responsibilities
- Lead the clinical science team (assign resources, coach, delegate, and guide).
- Provide oversight for clinical studies: planning, execution, completion, and reporting.
- Provide clinical/medical input for protocol, Informed Consent Form, and Investigator Brochure; lead protocol amendments and related documents.
- Provide clinical/medical input for data collection tools (e.g., EDC databases).
- Oversee review/analysis of clinical data and generation of study reports, publications, and clinical-regulatory documents.
- Draft and follow safety and data review plans; review patient and cumulative safety data.
- Draft clinical and safety sections of critical documents.
- Prepare/conduct presentations; support publications, abstracts, and presentations.
- Partner cross-functionally (basic research, translational science, clinical operations, regulatory, manufacturing, medical affairs, project management) to ensure GCP/quality execution.
- Help establish DMCs and endpoint adjudication committees; oversee charters, presentations, and outcomes documentation.
- Serve as key contact for clinical/medical protocol questions.
- Represent science function at meetings; provide scientific input at advisory boards and congresses.
- Review and manage protocol deviations.
- May support responses to regulatory queries, audit/inspection findings, and CTAs.
- Contribute to continuous improvement to maximize trial execution effectiveness.
Qualifications
- Nursing degree required; MSN with 10+ years or BSN with 12+ years progressive clinical research drug development experience (cell or gene therapy preferred).
- Knowledge of clinical development; global/regional regulation; ICH/GCP; adverse event management; clinical data review.
- Ability to collaborate on multi-functional drug development teams.
- Self-motivated, highly organized, detail-oriented, able to multi-task.
- Excellent oral/written communication and interpersonal skills; ability to influence and work cross-culturally/cross-functionally.