Sr. Director, Vaccine Development

Sr. Director, Vaccine Development
Company:

Jobot


Sr. Director, Vaccine Development

Details of the offer

Sr. Director, Vaccine Development
This Jobot Job is hosted by: Emmet Nitto
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $245,000 - $280,000
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, Vaccine Development to join our growing team!
Why join us?
Competitive Salary!
Great Benefits Package!
The Opportunity to Join an Amazing Team!
Job Details
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
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.


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