Director, CMC Project Manager (LVV)

Overview 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 Rocket Pharma is dedicated to bringing hope and relief to patients with rare, undertreated diseases through the development and commercialization of first-in-class, curative gene therapies. We are seeking an exceptional Director of Project Management to lead our PM team in coordinating and managing CMC activities across multiple departments as external CMOs and CTOs to advance our transformative cell- and gene-based therapies. The ideal candidate will have extensive experience in Pharma R&D project management, a deep understanding of the end-to-end drug development process, and a proven ability to deliver results in a fast-paced, high-stakes environment. This role requires a dynamic leader with the capability to manage a team of project managers, coordinate cross-functional teams, and navigate the complexities of CMC drug development. Success in this role will require excellent communication, interpersonal, and organizational skills, as well as the ability to thrive in a dynamic, fast-paced environment. Responsibilities * Drive the development and management of detailed and integrated development plans for CMC projects that account for all phases of drug development across TechOps functions with timelines, work plans (including interdependencies), budget, and risk management strategies.• Supervises and develops PMO staff with an emphasis on growing talent by providing timely and actionable feedback and growth opportunities for staff• Lead the planning and execution of high impact CMC projects and launch activities.• Oversee the delivery of project objectives per the program strategy, with a strong focus on meeting critical milestones, and managing scope changes while integrating project constraints.• Monitor project progress and measure project performance to identify areas for improvement.• Recommend/make adjustments as needed to ensure progress timelines and goals achievement.• Serve as the main point of contact for all CMC project-related communications, fostering strong relationships with internal teams, and external partners.• Facilitate effective collaboration across CMC functional teams, ensuring alignment on project goals and priorities.• Communicate project updates consistently to various stakeholders, including the leadership team, about strategy, adjustments, and development progress.• Coordinate as needed the preparation of high-quality regulatory submissions• Support department head to develop and manage in partnership with Finance project budget, detailed forecasting, and reporting, focusing on cost control and resource optimization, balancing project needs and organizational capacity.• Champion a culture of continuous improvement, identifying and implementing best practices in project management and drug development.• Stay abreast of industry trends, emerging technologies and regulatory changes, applying this knowledge to enhance project outcomes.• Implement advanced project management methodologies and tools to optimize project efficiency and effectiveness. Qualifications Education/Experience and Skills Requirements:• An advanced degree in science or engineering field is required.• At least 10+ years of pharmaceutical industry experience. Experience in the Cell & Gene therapy development program preferred.• At least 5+ years of project management leadership experience; with a primary focus on project/program management of CMC-related activities • Experience supervising team and developing individuals for career growth.• Demonstrated understanding of the drug development process including key disciplines involved in drug development (including but not limited to CMC, clinical, regulatory filing activities).• Experience utilizing project management tools and best practices to support CMC activities • Experience managing CMO/CTO relationships and projects • Excellent attention to detail, communication, time management, organizational skills, and flexible attitude to work assignments and new learning with proven ability to interact in a team environment • Strong cross-functional leadership in a matrix environment, with advanced skills in project management, organization, delegation, prioritization, and facilitation.• Comfortable in a fast-paced small company environment with the ability to manage a variety of projects simultaneously and handle rapidly changing information • Self-starter and must function well under minimal supervision • Project management professional (PMP) certification preferred• Expert MS Office skills with a specific focus on word processing, formatting, tables, spreadsheets, presentations, graphics, slides, and templates, in addition to Adobe Acrobat Desired Competencies:• Ability to effectively lead• Ability to develop and execute strategies • Handle issues appropriately and with a sense of urgency • Strong leadership to support a multi/complex projects environment in small biotech or large pharma • Ability to interact, cooperate and motivate across departments and functions • Strong capability for logical, analytical, and strategic thinking• Excellent Excel, PowerPoint, and MS project and server• Ability to develop complex worksheets and planning models • Good leadership and communication skills • Excellent interpersonal skills • Knowledge of project budgeting process, including financial planning/expenditures Travel Requirements: 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.

Created: 2024-10-22