Rocket Pharmaceuticals
Vice President, Chief of Staff
Rocket Pharmaceuticals, Cranbury, New Jersey, United States,
Work at ROCKET PHARMA and help cure rare diseases!
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position Summary:The Chief of Staff to Head of R&D and COO will lead and oversee all aspects of operations including development within the company, focusing on the advancement of gene and cell therapy programs from preclinical stages through to late-stage clinical development. This role is critical for ensuring the seamless integration of development activities, adherence to regulatory standards, timely execution of project milestones and achieving company’s operational excellence. The ideal candidate will bring deep expertise in biotech, particularly in gene and cell therapy, and strong scientific and business acumen.
Responsibilities:
Collaborate closely with the executive team to execute the overall R&D and company-wide operational strategy.
Development Program Management:
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.
Regulatory and Compliance Oversight:
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.
Process Development and Optimization:
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.
Operational Excellence:
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).
Team Leadership and Development:
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.
External Partnerships and Collaborations:
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.
Qualifications:
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.
EEO Statement:A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
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Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position Summary:The Chief of Staff to Head of R&D and COO will lead and oversee all aspects of operations including development within the company, focusing on the advancement of gene and cell therapy programs from preclinical stages through to late-stage clinical development. This role is critical for ensuring the seamless integration of development activities, adherence to regulatory standards, timely execution of project milestones and achieving company’s operational excellence. The ideal candidate will bring deep expertise in biotech, particularly in gene and cell therapy, and strong scientific and business acumen.
Responsibilities:
Collaborate closely with the executive team to execute the overall R&D and company-wide operational strategy.
Development Program Management:
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.
Regulatory and Compliance Oversight:
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.
Process Development and Optimization:
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.
Operational Excellence:
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).
Team Leadership and Development:
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.
External Partnerships and Collaborations:
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.
Qualifications:
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.
EEO Statement:A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
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