Our customer is a small biotech company with a combination product. They are looking for a Director of Insulin Drug Development to lead them from Phase I through Phase III clinical trials and BLA approval. This will be an onsite role in North Indianapolis.
Responsibilities :
- Lead a multidisciplinary team representing subject matter experts in key applicable areas
- Develop and implement technical strategies aligned with business objectives
- Collaborate with Portal leadership to define project scopes and deliverables
- Manage project timelines, resources, and budgets effectively
- Stay up-to-date with emerging science and industry trends and standards
- Conduct design reviews and provide technical guidance to team members
- Troubleshoot and resolve complex drug and drug-device compatibility related issues
Qualifications
PhD in Chemistry or >10 years relevant domain experience in insulin and drug chemistry
Strong understanding of regulatory submission expectations for drugsTechnical depth to assess compliance requirements of applicable standardsR&D through Phase 3 clinical testing experience strongly preferredInsulin experience preferred