Director, Global Clinical Development - Immunology - Germany, Belgium
Nr ref.: /JOBS.pl
Global Clinical Project Director and Associate Director within Immunology
Location: Germany, Belgium or UK based
Our client is a global biopharmaceutical company focused on the discovery and development of innovative medicines for the immune system, but is very different from other top 20 organisations, as they are not departmentalised or rigid in approach and have not grown through buying a number of other companies each year. This organisation has grown and developed by having a dynamic, innovative and entrepreneurial approach to drug development and product registrations and has considerably expanded its marketed products globally.
They are now recruiting for a number of Clinical Project Directors and Associate Directors for broad-based, strategic leadership roles for their highly regarded Immunology franchise. As well as ensuring that clinical trial activities are executed efficiently (e.g. within agreed timelines and budget) and to a high standard, meeting all appropriate regulatory requirements, you will represent the company and speak at conferences, symposia and meetings with Key Opinion Leaders.
These roles are a good mix of strategic input and global project management, and cover early and mid-phase development for biologicals. You will need enormous drive and enthusiasm, with the ability to inspire your team and the wider group to perform and achieve to a higher level. You will also be a savvy communicator with stakeholders and be used to ensuring buy-in to shape global strategies with the development, regulatory and commercial stakeholders.
The salary and packages for theses role are excellent and include a strong basic salary and bonus, with a very generous LTI package and options to work 2-3 days a week from home.
You will be responsible for all clinical aspects of the relevant development program(s) and accountable for clinical strategy and leading the development and execution of the clinical development program, including but not limited to:
Responsible for planning, designing, defending, and ensuring implementation of the Clinical Development Plans (CDP) enabling successful regulatory filings, approvals and launches of NCEs/NBEs and additional approvals of new line extensions (indications or formulations) of registered compounds. Prompt identification of safety or efficacy results that warrant re-evaluation of project plan and/or potential termination prior to registration. Develop and maintain excellent working relationships and global cross functional collaboration, between the PVU and Practice, to ensure broad high quality medical, scientific, regulatory, commercial and external input into the clinical programs. Develop a strong knowledge base of the relevant therapeutic area and drug development issues and become a company expert for the respective treatment to ensure that study concepts, Protocol Summaries and final protocols related to the relevant development plans are high quality, state of the art and aligned with related Clinical Development Plans and Target Product Profiles and is appropriately managed by the clinical study team(s).
Master's Required, PhD or Pharm D preferred Previous experience in biopharmaceutical clinical development including the management of multiple clinical studies Experience in writing and/or participation in the preparation of submission documents Knowledge of all aspects of the clinical development process and of the relevant therapeutic area preferred
If you wish to apply for this role, please send your CV with a covering note to or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on (0). ______________________________________________________________________________________________
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If you wish to apply for this role please click Apply Now, or send your CV with a covering note to . Alternatively to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the UK London office, on (0).
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