The Global Project Team Manager – LVV will support planning, budgeting, integrating, tracking and communicating cross-functional activities for the Company’s product development programs. This will include working with internal stakeholders, academic partners and the Company’s designated Contract Manufacturing Organizations (CMOs).
- Lead cross-functional teams, plan and execute a fully integrated CMC & program plans (Pre-Candidate Nomination to IND to Phase I/II/III) for development and commercialization of LVV gene therapy programs.
- Establish clear scope of work, 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.
- Establish project team framework for Core, Clinical and CMC teams and help define team charters, roles and responsibilities and key deliverables for each team.
- Manage vendors and successfully transfer viral vector production technology to ensure timely supply of Toxicology and clinical trial material to meet regulatory and commercial deadlines.
- Lead the planning and execution of tech transfers, risk management, qualification, validation, resource allocation, and training.
- Facilitate problem-solving, contingency planning, and decision-making.
- Build and maintain effective teams: motivate, recognize, coach & mentor team members.
- 5-6 years of LVV and/or AAV gene therapy experience
- Track record of leading and advancing projects from Discovery into Clinic including extensive experience with IND and BLA filings
- Experience in tech transfers, manufacturing, quality systems, CMO management, regulatory requirements, and commercial development
Education & skills
- Minimum BS in Biological Sciences, Bioengineering, Chemistry or an associated discipline with Masters or PhD preferred.
- Project management experience and/or PMP certification
- Experience managing CMO/CTO relationships and projects desired
- 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
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs.
Interested in joining our team?
Contact us today!
Resumes with cover letters may be submitted to firstname.lastname@example.org