A bit about us:
Based in Gaithersburg, MD we are a clinical stage biopharmaceutical company focused on developing liver disease and immune modulating therapies. We are looking for a Sr. Director, Clinical Vaccine Development to join our growing team!Why join us?
- Competitive Salary!
- Great Benefits Package!
- The Opportunity to Join an Amazing Team!
- Medical degree/MD
- Minimum seven (7) years in vaccine clinical research experience, preferably in the field of viral vaccines; phase 1-3 clinical trials; prior experience in -- viral vaccine business development experience activity desired
- Knowledgeable in medicine and pharmaceutical product safety
- Experience applying medical knowledge to the interpretation of individual case review
- Good Clinical Practice (GCP), ICH guidelines and all applicable regulatory requirements
- Oversee safety, including the review of SAEs and safety data; ensure that sites and regulatory agencies are notified, and all company and regulatory procedures are compliant
- Manage CRO’s; including identifying suitable partners, defining CRO responsibilities, communication plan, divisions of responsibility, milestones, contracts, reviewing monthly status reports, and maintaining interactive management to ensure project success
- Oversee regulatory filings, including drafting, editing and preparing of routine correspondence and sections of INDs, BLAs, NDA’s, Annual Reports
- Amendments, Supplements, Orphan Drug Applications and other regulatory submissions
- Oversee development and maintenance of clinical SOPs related to GCP activities