Project Manager-Drug Development
2 weeks ago
Seeking a Project Manager to become an integral part of our genetic medicine drug development effort. This individual will project manage drug development programs for the teams ranging from early research through IND, BLA, and MAA. The candidate will provide project management and drug development expertise to Research, Lab Operations and Development teams as well as cross functional stakeholders. This individual will partner with the team leads in driving the operational and strategic direction to meet the overall program goals and objectives. The individual will identify and manage key project deliverables, cross functional dependencies, milestones, and track research and nonclinical timelines via dashboards to ensure accurate planning, communication, decision making, and risk management. This Project Manager will work collaboratively with internal and external cross-functional teams, collaborators, and consultants to design and efficiently execute research and development programs that support clinical development and regulatory submissions.
RESPONSIBILITIES
- Conduct IND enabling in-vivo pre-clinical studies for multiple therapeutic programs in parallel using different animal models. Specific activities will include dose administration, in-vivo safety and efficacy parameters collection and evaluation, blood samples collection, necropsy and organs collection for subsequent testing.
- For each program, maintain high quality standards and rigorous quality control, as well as identify best practices and areas for process improvement.
- Document diligently on all experimental designs, protocols, data collection, and reports, supporting regulatory submissions.
- Coordinate logistics of non-clinical study specimens, manage tissue samples collection and processing.
- Write and review standard operating procedures (SOPs) and Analytical Methods.
- Collaborate with the research team on the platform technology development, internal pipeline strategy, candidate selection, and external activities such as R&D partnering and academic collaborations, as well as vendor management.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS
- BS/BA in Biological Sciences or closely related field of study
- 4-8 years of experience in drug development (pharma/biotech) w/ 2-3 years of project management experience
- IND/CTA and NDA/BLA development experience
- Demonstrated leadership and ability to work effectively with project teams.
- Ability to build / foster cross-functional collaborations both internally & externally
- Experience in genetic medicine drug development.
Other Qualifications
- Ability to work in a fast-paced, team-oriented environment.
- Strong planning and organizational skills
- Excellent written and verbal communication skills
- Experience in MS Project, PowerPoint, Excel, SharePoint, and Microsoft Teams
- PMP Certification a plus
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