JOB DESCRIPTION
Job TitlePre-Clinical/Clinical Project Manager
Position TypeFull time
LocationRemote
Travel RequiredNo expected travel
External Posting URLApplications Accepted ByAudra Miller
Mail:
Audra Miller
Pintail Solutions, Suite 1040
12172 Visionary Way
Fishers, IN 46038Job DescriptionOverview
Pintail Solutions is committed to moving business forward. We work with a variety of clients including biotechs and pharmaceutical companies, CROs, academic institutions, and philanthropic organizations. Clients work with Pintail because of our breadth of experience, our ability to deliver outcomes, and our passion for every project we work on. We focus on the greater good of the client and are fearless about informing clients about what they need instead of what they may ask for. We expect everyone in the company to act like an owner and be insatiable about looking for ways to improve. We value excellence, integrity, and collaborations and we believe we will make a greater difference in our work when we are having fun doing it.
The
Pre-Clinical/Clinical Project Manager (PM) role is focused on partnering with a start-up organization spinning out of a very prestigious academic institution.
This individual will need an entrepreneurial spirit, deep pre-clinical project management experience (e.g., Lead Optimization, Candidate Selection, Non GLP toxicology, non-clinical CM&C activities, pre IND, etc.) Experience in pharma, start-up, academic research, or CRO is strongly preferred as well as a strong background in managing government grants ie NIH, BARDA etc. This is pre IND through first in human Phase 1 clinical project management.
Roles And Responsibilities
Project Manage pre-clinical and early phase milestone activities including but not limited to:
- Develop and manage detail project plans, including deliverables, required capabilities and budgets
- Oversee all aspects of multi-functional pre-clinical work (Chemical SAR, Disposition, Toxicology, Regulatory, CM&C etc)
- Plan and execute multi-functional pre-clinical and clinical work including First Human Dose and Phases 1 and 2 trials
- Manage communication across academic and industry leaders to ensure seamless delivery
- Research, qualify and manage relationships with partners
Project manage all milestones and deliverables in government/BARDA grant contract and SOW
- Overall management, integration and coordination of all contract activities to ensure the efficient planning, initiation, implementation, and direction of all contract activities
- Serve as a BARDA liaison with responsibility for communication with the contracting officer
- Attend meetings, prepare and deliver all required reporting to BARDA
Qualifications And Education Requirements
Candidates should have a 4 year college degree and at least 5+ years project management experience in a pre-clinical to phase 1 study.
- Ability to lead others through influence and be technically savvy
- Ability to work cross functionally both internally and externally with executive leaders, internal and external stakeholders, vendors and partners, government agencies, and other leading consultants
- Experience managing government contracts, preferably BARDA
- Background in a variety of functional areas in pre-clinical and early phase drug development
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