Clinical Operations Director

2 days ago


Cranbury, New Jersey, United States Rocket Pharmaceuticals Full time
Overview

Rocket Pharmaceuticals is a pioneering biotechnology company dedicated to advancing gene therapies for rare and devastating diseases. We are seeking an exceptional Associate Director, Clinical Operations to join our team and contribute to our mission of making a meaningful difference in the lives of patients.

Responsibilities
  • Provide strategic oversight and operational execution of the Clinical Operations function within the Lentiviral vector (LV) portfolio.
  • Manage timelines, budgets, clinical sites, vendors, and deliverables while maintaining quality and regulatory compliance.
  • Collaborate with internal and external stakeholders to ensure expected timelines, quality standards, Good Clinical Practices (GCP), and applicable regulations are met.
  • Develop and oversee clinical site budgets, investigator and vendor payment processes, and invoices related to projects assigned.
  • Lead cross-functional team efforts on review of clinical data listings, protocol deviations, and study data review.
  • Ensure that internal study teams and clinical sites have the appropriate study management tools to execute the study.
  • Collaborate with Clinical Quality Assurance (CQA) to ensure GCP/GPV inspection readiness of the organization, its vendors, and its clinical investigators/sites.
Requirements
  • Bachelor's degree in health care or life sciences or other related field of study.
  • Minimum of 10 years of relevant clinical trial experience in the pharmaceutical or biotech industry, clinical research organizations, and/or clinical research experience in a healthcare setting.
  • At least 6 years of direct experience in managing clinical trial programs (start-up through close-out) including vendor management, in a global environment.
  • Experience in managing Clinical Trial Manager(s) and Clinical Research Associates/Assistant(s).
  • Experience in gene therapy, rare/orphan disease highly desired.
  • Experience in regulatory filings (NDA, BLA, MAA) & health authority inspections highly desired.
Desired Competencies
  • Ability to adapt and prioritize competing demands within a dynamic environment.
  • Outstanding organizational, time management, planning, and record-keeping skills.
  • Advanced skills in Project Management, particularly regarding management of schedule, budget, communication, resources, and quality.
  • Advanced communication, presentation, interpersonal, and negotiating skills.
  • Ability to analyze, evaluate, and prioritize key issues and problems, and subsequently seek-out and recommend possible solutions and mitigation strategies before escalation.
Travel Requirements

Ability to travel approximately 10-20%.



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