Medical Monitor, Clinical Development

  • Location

    Hertfordshire, England

  • Sector:

    Life Sciences

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Vladyslav Babych

  • Contact email:

    Vladyslav.Babych@volt.eu.com

  • Job ref:

    76355-PHARM-VLB_1584113666

  • Published:

    9 months ago

  • Duration:

    6 months

  • Expiry date:

    2020-04-12

  • Start date:

    ASAP

This will start as 0.6 FTE Contract for 6 month, and will evolve from that in lines with business and project progress.

A brief description of the project is here for you.

The project has been already approved
Phase 1/2 trial has started to evaluate the IP in patients with Fabry Disease.
Study sites have been selected in the UK, US, Germany, Norway, Italy and Denmark.
The first patient has been dosed.

Medical Monitor will be ensuring medical oversight and compliance of the trials and will lead generation of clinical evidence of safety and efficacy.
They will also be involved in preparing dossier for product candidates to be approved by the US Food and Drug Administration or any other regulatory agencies.

This role requires:

- Full Medical Qualification
- Minimum 5 years experience in Medical Monitoring in early phases
- Experience in LSD domain or other rare disease is preferred