Passage Bio is seeking a motivated and experienced Director of Project Management to support cross-functional product development teams.
- Establish and maintain mechanisms to track progress and completion of CRO deliverables and obligations for analyzing in vivo studies from Discovery Research through human clinical trials and commercialization.
- Manage CRO site relationships and resolve issues of moderate to high complexity.
- In a matrixed environment, interface cross functionally in prioritizing assigned product support activities. Identify areas of risk to development timeline, including CMC, clinical operations, regulatory, and other contributing departments to drug development.
- Create and maintain project/program plans, timelines, agendas, budgets, resourcing requirements, rolling summaries, and other tools to facilitate planning and coordination of deliverables for the project/program.
- Manage all aspects of program/project team meetings in the assigned therapeutic area(s) as it pertains to in vivo pharmacology, toxicology, biomarkers and bioassays. This might include developing meeting agendas, maintaining meeting minutes, developing presentations and proposals, and any other necessary content.
- In collaboration with the CMO, Head of Development and VP of Development, deliver project/program updates to project team and/or to senior leadership as necessary and appropriate.
- Work closely with CMO, Head of Development and VP of Development to identify areas of program risk and collaborate with the project team to propose risk mitigation strategies.
- Under the direction of the CMO, Head of Development and VP of Development manage contracts with CROs for outsourced activities, including contract changes, issue resolution, contract clarifications, and study reports.
- Work closely with the Project Manager at the Gene Therapy Center to understand preclinical work, timelines, and impact to planned development activity.
- Work closely with Project Manager at the Orphan Disease center to understand the natural history study timelines and impact to planned development activity.
- BA or BS degree required; Master’s or other advanced degree preferred.
- 5-10 years of project management experience in the life sciences and/or biotech/pharmaceutical industry. The ideal candidate will have experience in project management, operational planning, and/or contracts management. Experience with IND regulatory submissions and/or Phase 1 clinical trials is particularly desirable.
- Practical working knowledge of project management techniques and concepts as they apply to the biotech/pharmaceutical industry.
- Previous experience managing outsourced contracts and success at documenting and administering the contract terms and requirements.
- Keen attention to detail; exceptional organizational skills.
- Excellent written and oral communication skills.
- Must be able to work independently and within team environments.
- Ability to prioritize tasks, adapt to shifting priorities, and deliver on projects in a timely manner.
- Ability to capture technical discussion in the form of meeting minutes, decision points and action items.
- Experience working in cross-functional product development teams and in particular in a scientific or clinical setting is desired.
- Ability to confidently and respectfully interact with all levels of management.
- Experience in regulatory affairs, clinical operations, and/or manufacturing is additionally desirable.
- Proficient in relevant software: MS Project or other project management software, Excel, PowerPoint, Word, Access, etc. in addition to general knowledge with shared work environments.