Ben Traies at CK Clinical is currently recruiting for a Director of Clinical Development to join the Head Quarters of a Pharmaceutical company based in Hertfordshire.
The role:
In this high profile role, you will join and contribute to a team focused on the clinical development of a new chemical entity, with the overall aim of achieving regulatory approval for a number of indications.
Responsibilities:
- Applying medical and clinical development knowledge to transform clinical research ideas into high quality clinical answers
- Providing medical input to the strategies for clinical studies, being responsible for the key design elements of clinical study protocols, while focusing on innovative design, medical execution and interpretation.
- Working with study teams to resolve any medical problems, acting as principal contact on scientific and medical issues for the functional lines represented within the study team.
- Accountable for the medical and scientific validity of clinical studies, especially in conclusions concerning efficacy and safety.
- Assisting in the preparation of the clinical content of regulatory submissions/documents and in the resolution of clinical queries from regulatory agencies and investigators.
- Initiating and managing external collaborations to develop new methodologies, biomarkers and/or Outcomes Research measures.
- The ability to serve as a Study Director and function at a high level within a global matrix team environment will be important.
The ideal candidate:
To be considered for this Director of Clinical Development role, you will have the following skills, experience and qualifications:
- Proven clinical development experience (in the Phase II-III area) or other relevant experience in order to have a medical and scientific understanding of a clinical discipline.
- Demonstrated potential or ability to design, initiate and conduct clinical studies.
- Experience in regulatory interactions throughout the different phases of development.
- Medical degree or PhD with demonstrable industry experience
How to apply:
For more information or to apply for this Director of Clinical Development position, please contact Ben Traies on 01438 870021 or email btraies@ckclinical.co.uk.