Rocket Pharmaceuticals - Cranbury Township, NJ

posted about 1 month ago

Full-time - Senior
Cranbury Township, NJ
Chemical Manufacturing

About the position

The Chief of Staff to the Head of R&D and COO at Rocket Pharma will lead and oversee all operational aspects of the company, focusing on the advancement of gene and cell therapy programs from preclinical stages through late-stage clinical development. This role is critical for ensuring the seamless integration of development activities, adherence to regulatory standards, and timely execution of project milestones, contributing to the company's operational excellence.

Responsibilities

  • Collaborate closely with the executive team to execute the overall R&D and company-wide operational strategy.
  • Oversee the planning, coordination, and execution of all development activities, including preclinical research, process development, clinical manufacturing, and regulatory submissions.
  • Lead cross-functional teams, including project management, clinical operations, regulatory affairs, and quality assurance, to ensure alignment and efficiency across all development stages.
  • Ensure timely and cost-effective delivery of program milestones, mitigating risks and resolving issues proactively.
  • Work closely with regulatory affairs to ensure that all development activities comply with global regulatory requirements, including FDA, EMA, and other relevant authorities.
  • Oversee the preparation of regulatory submissions, including INDs, BLAs, and CTAs, ensuring high-quality documentation and timely approvals.
  • Drive the development and optimization of scalable and robust manufacturing processes for gene and cell therapy products.
  • Ensure technology transfer and process validation activities are conducted efficiently and meet regulatory standards.
  • Establish and maintain best practices in project management, resource allocation, and budget management to ensure operational efficiency and effectiveness.
  • Implement and refine systems and processes to track project progress, manage risks, and report on key performance indicators (KPIs).
  • Build, mentor, and lead a high-performing development operations team, fostering a culture of collaboration, innovation, and continuous improvement.
  • Provide ongoing professional development and career growth opportunities for team members.
  • Cultivate and manage relationships with key external partners, including CROs, CMOs, academic institutions, and strategic collaborators.
  • Negotiate and manage contracts and agreements to support development activities.

Requirements

  • Advanced degree in life sciences, biotechnology, or a related field (Ph.D., Pharm.D., M.D. preferred) and a business degree (MBA).
  • 15+ years of experience in the biotech or pharmaceutical industry, with a strong focus on gene and cell therapy.
  • Proven track record of successfully leading development operations, including preclinical and clinical development, regulatory submissions, and process development.
  • Deep understanding of global regulatory requirements for gene and cell therapy products.
  • Strong leadership skills with a demonstrated ability to build and lead cross-functional teams.
  • Excellent project management, problem-solving, and decision-making skills.
  • Exceptional communication and interpersonal skills, with the ability to effectively engage with internal teams and external partners.
  • Strategic thinker with the ability to balance short-term execution with long-term planning.
  • Highly collaborative and capable of working in a fast-paced, dynamic environment.
  • Strong business acumen and understanding of the biotech industry landscape.
  • Passionate about advancing innovative therapies to improve patient outcomes.

Benefits

  • Competitive compensation package featuring a generous 401K match and stock options.
  • Excellent health benefits.
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