Job Scope:
In first two months this consultant will be working with one of the leads up to governance(end of may). Day to day the candidate will be working with selected individuals on a governance presentation working with both development and commercial teams. If everything goes right, this consultant will then become the PM for the Global Development Team(dozen or so individuals) to advance molecules through developments and enable studies. This is an HIV Asset in Phase 1 Development Stage. Need help transitioning to Phase 3. If passes governance approval, they will immediately hoping in Phase 2 and 3 clinical trial. Licensing and Enabling. Will be working with the Regulatory Teams/Cruss Functional Teams. Need to understand the process moving from non-clinical to clinical.
Must have at least 10 plus years experience and at least 5-10 years of drug development and PM experience for Pharma/Bio/Therapeutic companies. Must be proactive and lead a team of 12. Must have some clinical experience and some CMC knowledge. Does not need to be a Clinical or CMC expert, as other team members will cover those areas. Will be the PM for the project as a whole, documenting and addressing action items for the day. Must have phase I II and III experience and advanced skills with Teams, Outlook, SharePoint. Planisware is a strong plus (can train on this as long as have a strong MS Project background). BS required, scientific preferred.
Skills:
- Program Manager
- Phase I-III studies
- At least 5 -10 years Drug Development PM Experience***
- Virology (preferred but not necessary, example oncology would be okay)
- CMC knowledge (preferred)
- MS Project/ Planisware experience (preferred)
Education:
BS
PMP – PLUS
On-Site: Drug Development Program Manager (234761)
