Director, Gene Therapy Clinical Science

Rocket Pharmaceuticals•Cranbury, NJ

20h•$206,000 - $248,000

About The Position

Create a future where DNA is no longer destiny. Join Rocket Pharma. Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits. Position Summary 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.