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 onfor 3-4 more years.
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.
Home-based, with company sites in the UK and Germany.
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 settingup 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.
- >20 years experience in drug development
- 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.
For more information or to apply for this position, please contact Hendre Moolman on 01438 842970 or email firstname.lastname@example.org Please quote reference 49947 in all correspondence.