Interim Medical Director

Location
Home-Based
Salary
Highly competitive
Posted
24 Feb 2021
Closes
26 Mar 2021
Ref
49947
Contact
Hendre Moolman
Discipline
Medical Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Senior Management
CK Group are recruiting for a Interim Medical Director to join a global pharmaceutical company based in Germany (although the role can be based anywhere in the EU or US - home-based). The contract is initially for 1 year with the potential to go on for 3-4 more years.

The Company:
Our client is a global leader in pain management. Their purpose is to change lives for the better – and innovation is their passion. They drive to seek effective, life-changing medicines and solutions for patients with severe diseases and high unmet medical needs.

The Location:
Home-based, with company sites in the UK and Germany.

The Role:
The main purpose of the role will be to
  • Creating and maintain the clinical development plan and the clinical strategy for a research & development project in alignment with the target product profile to which you also provide clinical input.
  • Ensuring that clinical strategy and clinical trial designs are aligned with and appropriately challenged by internal and external stakeholders.
  • Being accountable for ensuring timely delivery and adequate quality of the clinical parts of project and submission documentation as to ensure smooth internal decision-making and negotiations with health authorities and payors and a viable product label.
  • Understanding the competitive landscape and provide both business intelligence and you have medical expertise in relationship to the indication and compound.
  • Representing the company's medical expertise in meetings with regulatory authorities, payors/HTA bodies, advisory boards and external medical experts
  • Designing and execute clinical trials by knowledgeably managing external vendors/CROs
  • Taking responsibility as medically qualified person according to ICH E6 and you are involved as such in the preparation of advanced protocol synopses, trial protocols, trial reports and investigator brochures.
  • Consulting with external medical experts and medical key external experts in setting up clinical development programs and individual clinical trials.
  • Being accountable for primary publications of trials in alignment with the publication strategy and in agreement with regulatory requirements.
Your Background:
  • >20 years experience in drug development
  • MD.
  • Must have brought one or more drugs to the market in EU and ideally in US.
  • Experience in CNS and potentially in pain (optional but advantageous).
  • Could cover the role of PL and Medical Lead.
Please quote reference 49947 in all correspondence.