Director, Gene Therapy Clinical Science

Rocket Pharmaceuticals • Cranbury, NJ

1d • $206,000 - $248,000

About The Position

Rocket Pharma is currently seeking a dynamic, and highly motivated Director, Gene Therapy Clinical Science. The candidate will support, guide and implement clinical development strategy and plans. Responsible for the timely execution of First in Human programs through proof of concept and delivery on clinical study designs, high quality trial execution, and preparation of clinical protocols. The candidate will be responsible for leading, developing, and managing clinical studies while building and maintaining relationships with investigators and key opinion leaders. In addition, candidate will be accountable for the medical & scientific integrity of the study and the wellbeing of the patients enrolled in one or more clinical trials. Maintains compliance with all internal and external standards, proactively mitigates risk and manages emerging clinical/medical issues in a timely manner. The position will report to the Associate Vice President, AAV Global Program Head.

Requirements

• PhD/PharmD and 8+ years, MA/MS/MSN and 10+ years, BA/BS/BSN and 12+ years of progressive experience in clinical research/development with cell or gene therapy in the pharma industry.
• Experience in clinical research/ drug development with cell or gene therapy, especially in early development; familiarity with related disciplines.
• Knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management and clinical data review is required.
• Must have ability to work collaboratively as part of a multi-functional drug development team in a dynamic environment.
• Must be self-motivated, highly organized, detail-oriented and able to multi-task, delivering high quality work.
• Excellent oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.

Responsibilities

• Leading the clinical science team - responsible for assigning resources and coaching clinical scientists (with ability to delegate and guide).
• Provide leadership, oversight, and management of clinical studies including planning, execution, completion, and reporting of clinical trials.
• Provides clinical/medical input to support development of the protocol/ Informed Consent Form and Investigator Brochure. Leads development of protocol amendments, and other related documents.
• Provides clinical/medical input to the development of data collection tools, such as EDC database and other related tools, as applicable.
• Oversee the review and analysis of clinical data and the generation of study reports, publications, and clinical-regulatory documents.
• Oversee and conduct data review, analysis, and interpretation of clinical trials data
• Drafts and follows safety and data review plans to perform and document regular review of patient safety data and perform review of cumulative safety data
• Draft clinical and safety sections of critical documents
• Prepare and conduct presentations regarding strategy and/or data and support and assist in the development of publications, abstracts and presentations
• Partners with cross functional teams, such as basic research, translational science, clinical operations, regulatory affairs, manufacturing, medical affairs, project management etc as needed to ensure compliance with GCP and quality execution of plans that involve patient samples, analysis and clinical data
• Help with establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees. Oversee related charter development, committee presentations and documentation of outcomes.
• Serves as the key contact with external investigators and internal study team for questions relating to clinical/medical aspects of protocol.
• Represents the science function at key meetings, give scientific input at ad boards, congresses etc.
• Reviews, and manages protocol deviations.
• May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs)
• Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.

Benefits

• Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.
• medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year’s, and a variety of wellness resources and employee support programs.
• Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree