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Project Manager - Drug Development

SOUTH SAN FRANCISCO, CA 94080

Posted: 06/04/2024 Employment Type: Direct Hire/Perm Job Category: Project Management Job Number: 606206 Is job remote?: No Country: United States

Job Description


Job Description

Seeking to hire 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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About SOUTH SAN FRANCISCO, CA

Ready to take the next step in your career journey? Explore our job opportunities in the vibrant area surrounding South San Francisco, California! Known for its proximity to the iconic Golden Gate Bridge and the bustling tech hub of Silicon Valley, this region offers unrivaled growth potential and a dynamic work environment. With a unique blend of culture, including the renowned SFMOMA art museum, the lively Castro District, and delectable cuisine like the famous sourdough bread at Boudin Bakery, South San Francisco is the perfect place to thrive professionally while enjoying the beauty of nearby parks like Golden Gate Park and the breathtaking views of the Pacific Ocean. Join us in discovering the endless possibilities for your career in this enchanting region!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.