​Senior Director of Infectious Disease - Remote

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: 21273
Published: 9 days ago
Expiry date: 01 May 2021

**REMOTE US BASED OPPORTUNITY**

We are currently working with a large pharmaceutical company who is looking to add a senior leader to their Clinical development team.

Looking for a team oriented individual with a successful track record within the industry. Ideal candidate will collaborate with cross functional teams such as Clinical Development, Safety, Regulatory, Clinical Operations, and Research and Development.

Will report directly to the Head of Clinical Development and serve as a Medical and Clinical Development expert.

Responsibilities

  • Responsible for design and development of clinical development plans.

  • Support the design and strategy of the Integrated Evidence Plan

  • Be a key leader in developing and progressing specific vaccine development.

  • Be a leader in submission of IND, NDA, BLA, MAA documents.

  • Establish Clinical Development Timelines in a quick and organized manner.

  • Implement clinical R&D policies, SOPs and related directives.

  • Design clinical protocols and standards within the clinical development plan.

  • Oversee review of clinical study entries.

  • Collaborate with vendors and Investigators on specific projects.

  • Accountable for clinical components of the Medicine Profile.

  • Work with both preclinical and translational teams, and external experts.

Experience Required

  • MD Infectious Disease subspecialty training preferred.

  • Antiviral Drug development experience required.

  • 5-10 years of drug development experience within pharma, biotech, or CRO required.

  • Experience managing other MD's and Clinical Scientists.

Salary: On application