Associate Director, Program Management AAV
Rocket Pharmaceuticals - Cranbury, NJ
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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.Rocket Pharma is seeking an Associate Director Program Management, AAV, to ensure the smooth operation of lead one of more of the Company’s clinical-stage AAV product development programs and drive delivery of the project goals. Responsibilities include overseeing all aspects of clinical program management from early- through late-stage clinical development, in addition to overseeing the IND-enabling work of one of more pre-clinical AAV pipeline programs to IND. Specific project management activities (managing scope, time, cost and quality) include cross-functional integration as well as ensuring that key project milestones are defined and met and that appropriate communications occur with stakeholders across functions and/or external partners. The candidate should have commensurate experience in the biotechnology industry to understand both pre-clinical / IND and clinical drug development process in biologics or gene therapy, and be skilled in the use of Project Management tools such as Smartsheet, SharePoint sites, etc. Alliance management with internal and external stakeholders will also be an important component of the role. Experience working on cross-functional teams is highly desired as well as an understanding of facilitating high functioning teams.• Manage timeline, cost, risks and cross function integration for pre-clinical-stage program (s) up to IND Filing and late-stage clinical PM until BLA filing.• Report directly to the Senior Director, Program Management AAV.• Develop and drive operational strategies for cross-functional project teams• Plan and execute fully integrated program plans (Pre-Candidate Nomination to IND and late-stage clinical) for development of gene therapy programs.• Establish clear scope of work and lead the delivery of project milestones on time and within scope through utilization of project management standards.• Co-ordinate and track status of cross-functional communication and integration activities.• Proactively anticipate issues, challenges, and assumptions as well as identify contingencies or opportunities to circumvent potential delays. Follow-up on assignments and report progress to the team.• Establish project team framework for Translational science, analytical and CMC teams and help define team charters, roles and responsibilities and key deliverables for each team.• Manage external stakeholders and vendors to ensure timely fulfillment of commitments to meet regulatory and commercial deadlines.• Lead the planning and execution of risk management, resource allocation, and training.• Facilitate problem-solving, contingency planning, and decision-making.• Build and maintain effective teams: motivate, recognize, coach and mentor team members.• BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline (Master’s or PhD preferred).• 8 -10 years of experience with at least 5 years of biotechnology or drug development experience. Gene or cell therapy experience a plus.• Track record of leading and advancing projects from Discovery into Clinic including experience with ND filings.• Experience in CMO and CRO management, regulatory requirements, and commercial development.• Project management experience and/or PMP certification.• Working knowledge of US and European regulatory requirements.• Outstanding organizational skills.• Excellent written and oral communication skills.• Ability to operate in a fast-paced, multi-disciplinary industrial environment.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: 2024-09-07