Associate Director of Clinical Development

Location United States
Discipline: Medical & Pharmacovigilance
Job type: Permanent
Salary: £Salary: On application
Contact name: Josh Swistak

Contact email: josh.swistak@rbwconsulting.com
Contact phone: 16179821238
Job ref: 20993
Published: about 1 month ago
Expiry date: 11 April 2021

​Location: Remote, US

  • Responsible for clinical development plans.

  • Analysis of scientific and medical content of all clinical programs is accurate and concise.

  • Convert pre-clinical and early clinical findings into clinical development plan

  • Present and defend protocols and clinical development plans at internal governance forums.

  • Act as a Medical Monitor and Safety Monitor of clinical trials

  • Medical expert for Phase 1 – Phase 3

  • Monitor and analyze study progress collaborate with Data Management team

  • Collaborate with the Regulatory team to develop Dossiers, BLAs, INDs, and Annual reports.

  • Develop and Implement R&D policies and SOPs.

Experience Required:

  • Immunology background

  • Autoimmune disease, NeuroImmunology, transplantation experience a plus

  • MD with a valid US Medical license

  • Clinical Development industry experience preferred

  • Clinical Research/drug development experience in Academia or industry is required.

Salary: On application