Sr. Director, Clinical Vaccine Development

  • Gaithersburg, MD
  • $245,000 - $280,000
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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!

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

Easy Apply Now
Easy Apply Now
Job Details
Location
Gaithersburg, MD
Job Type
Permanent
Compensation
$245,000 - $280,000