Director, Gene Therapy Clinical Science
Rocket Pharmaceuticals
6 hours ago
Remote friendly (United States)
United States
Clinical Research and Development
Responsibilities:
- Lead the clinical science team; assign resources and coach clinical scientists (delegate and guide).
- Provide leadership, oversight, and management of clinical studies (planning, execution, completion, and reporting of clinical trials).
- Provide clinical/medical input for protocols, Informed Consent Forms, and Investigator Brochures; lead development of protocol amendments and related documents.
- Provide clinical/medical input for development of data collection tools (e.g., EDC databases).
- Oversee review and analysis of clinical data and generation of study reports, publications, and clinical-regulatory documents.
- Oversee and conduct data review, analysis, and interpretation of clinical trials data.
- Draft and follow safety and data review plans; regularly review patient safety data and cumulative safety data.
- Draft clinical and safety sections of critical documents.
- Prepare and conduct presentations on strategy and/or data; support publications, abstracts, and presentations.
- Partner with cross-functional teams (basic research, translational science, clinical operations, regulatory affairs, manufacturing, medical affairs, project management) to ensure GCP compliance and quality execution.
- Help establish Data Monitoring Committees (DMCs) and endpoint adjudication committees; oversee charters, presentations, and documentation of outcomes.
- Serve as key contact with external investigators and internal study team for clinical/medical protocol questions.
- Represent science function at key meetings; provide scientific input at advisory boards and congresses.
- Review and manage protocol deviations.
- May support responses to regulatory queries, audit/inspection findings, and Clinical Trial Applications (CTAs).
- Contribute to continuous improvement/process enhancement to maximize clinical trial execution effectiveness.
Qualifications:
- Nursing degree required; MSN with 10+ years, or BSN with 12+ years of progressive experience in clinical research drug development (preferably cell or gene therapy in the pharma industry).
- Knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management, and clinical data review.
- Ability to work collaboratively in a multi-functional drug development team in a dynamic environment.
- Self-motivated, highly organized, detail-oriented, and able to multi-task; delivers high-quality work.
- Excellent oral and written communication; strong interpersonal skills and ability to influence effectively across cultures and functions.
- Lead the clinical science team; assign resources and coach clinical scientists (delegate and guide).
- Provide leadership, oversight, and management of clinical studies (planning, execution, completion, and reporting of clinical trials).
- Provide clinical/medical input for protocols, Informed Consent Forms, and Investigator Brochures; lead development of protocol amendments and related documents.
- Provide clinical/medical input for development of data collection tools (e.g., EDC databases).
- Oversee review and analysis of clinical data and generation of study reports, publications, and clinical-regulatory documents.
- Oversee and conduct data review, analysis, and interpretation of clinical trials data.
- Draft and follow safety and data review plans; regularly review patient safety data and cumulative safety data.
- Draft clinical and safety sections of critical documents.
- Prepare and conduct presentations on strategy and/or data; support publications, abstracts, and presentations.
- Partner with cross-functional teams (basic research, translational science, clinical operations, regulatory affairs, manufacturing, medical affairs, project management) to ensure GCP compliance and quality execution.
- Help establish Data Monitoring Committees (DMCs) and endpoint adjudication committees; oversee charters, presentations, and documentation of outcomes.
- Serve as key contact with external investigators and internal study team for clinical/medical protocol questions.
- Represent science function at key meetings; provide scientific input at advisory boards and congresses.
- Review and manage protocol deviations.
- May support responses to regulatory queries, audit/inspection findings, and Clinical Trial Applications (CTAs).
- Contribute to continuous improvement/process enhancement to maximize clinical trial execution effectiveness.
Qualifications:
- Nursing degree required; MSN with 10+ years, or BSN with 12+ years of progressive experience in clinical research drug development (preferably cell or gene therapy in the pharma industry).
- Knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management, and clinical data review.
- Ability to work collaboratively in a multi-functional drug development team in a dynamic environment.
- Self-motivated, highly organized, detail-oriented, and able to multi-task; delivers high-quality work.
- Excellent oral and written communication; strong interpersonal skills and ability to influence effectively across cultures and functions.