Hobson Prior are working with an excellent pharmaceutical organisation who are focused on providing innovative products to help with people who suffer with a lack of iron. Our client is looking for a Clinical Development Director to join them on a permanent basis. For more information on this role please get in touch now!

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• You will represent the company as the scientific subject matter expert at external meetings including those with Investigators, Steering Committees, Key Opinion Leaders and Advisory Groups.
• Uphold and evaluate current knowledge of key disease areas, providing information to appropriate groups as needed.
• To provide leadership of clinical study/program to ensure delivery of clinical trials per ICH-GCP requirements and meeting timelines and budget.
• To author protocols, and provide scientific input into manuscripts/publications, IBs, regulatory and study reports.
• Leadership and moderation of clinical advisory boards and ongoing interactions with applicable committees relevant to successful conduct of studies and programs.
• In partnership with a cross-functional team, drive the development of effective and innovative clinical trial designs, and facilitate execution of clinical trials by supporting site and CRO personnel, safety monitoring activities, data clean-up activities, data analyses, and clinical study report development and finalization.
• Research and analyse scientific/medical information and data with respect to clinical trials, safety databases, and other medical/scientific elements necessary for decision-making and regulatory submissions.
• Assess safety data including labs and SAEs on an ongoing basis for ongoing clinical trials; manage DSMB processes for clinical trials.
• You will provide Medical Oversight and Medical Monitoring to interventional clinical trials (supported by CROs, if applicable).
• Evaluate investigator-initiated protocols and make recommendations (if applicable).

Requirements:

• MD (strongly preferred) or internationally recognized equivalent degree or PhD in science/health-related discipline.
• A minimum of 6 to 10 years of pharmaceutical industry experience gained in clinical research.
• Knowledge and experience of clinical trial design, data analysis, statistics and research methods.
• Knowledge of the drug development process and clinical research methodologies.
• Trained in GCP regulations, and familiar with ICH and FDA guidelines relevant to clinical development.
• Experience in Nephrology clinical trials would be preferrable.
• Experience in writing and submission of Health Authority documents (e.g., NDA, sNDA, MAA) desired.
• Ability to work self-sufficiently and in a fast paced, hands-on, flexible, dynamically changing environment.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.