Interim Medical Director

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.