Clinical Development Director ** Germany ** Relocation Offered

Reference: MG011119

Expiry Date: 01-01-2020

Categories Clinical Research, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
K
Germany

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Job Description

Clinical Development Director ** Germany ** Relocation Offered

My client is a leading bio-pharmaceutical company offering a position as a Clinical Development Director to work on a late phase NME, in Neurology. This clinical development role will be part of their late phase development and commercialization team (this is a clinical role not a medical affairs one).

You will be an MD, whom has prior research physician / clinical development physician experience, and be willing to work with global teams, to help this drug, which has a strong potential clinical value proposition, to reach the patient, joining it at end of Phase 2, and taking it through its Ph 3 programmes, readout and MAA/NDA submission.

This is a progressive company with a strong track record in neurology, and you will be part of an inner group which supports multiple molecules, so once this has finished, you need not concern yourself with where the next project comes from.

To apply for this role, you will have prior experience / knowledge of the following:-

  • Input into CDPs, protocols, as well as later readouts, CSRs, co-review with PhV on potential signals, safety submissions and full MAA/NDA regulatory submissions (inc. support for / attendance of HA meetings, EOP2, Pre-MAA, Review)
  • On-going oversight for your clinical studies running, working with clinical operations and vendor / CROs in Phase 2b/3a/3b to triage any bumps in the road with the Investigator Sites
  • Support for publications, KOL engagement and Congress, symposia and round tables
  • Involvement with support for data generation to support access and commercialization
  • Prior experience in neurology / CNS.

 

To Apply!

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