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Project Manager - Drug Development
201 Haskins Way SOUTH SAN FRANCISCO, CA 94080 US
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/ 3-5 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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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