Director Clinical Development

Proclinical is seeking a Director Clinical Development for a global biotechnology company to be based in London on a permanent basis. The successful candidate's primary role will be as clinical lead in a late phase clinical development program in a rare genetic or cardio-metabolic disease. He/she is expected to play a leading and influencing role in the overall clinical development strategies for the molecules and drive progress and operational excellence for associated clinical trials. In addition, this role will include interaction with the company's research group, helping to advise the team on the clinical development feasibility of novel targets and the design of proof-of-concept studies. This work will also involve extensive consultation and collaboration with external experts. It is expected that additional opportunities will arise to lead bench-to-bedside early phase clinical development programs.

The Director/Sr. Director, Clinical Development will work in a matrix organization across Preclinical, Regulatory & QA teams to ensure fully harmonized and integrated development strategies. He/she will be a key company Development spokesperson at external meetings, including regulatory interactions and scientific meetings.

Job Responsibilities:

• Be the strategic leader providing a strong, clear voice for the clinical program.
• Develop creative but realistic approaches to drug development and lead clinical efforts to secure global regulatory approvals.
• Provide strategic consultation and guidance to Research on all decisions that have significant clinical components and implications.
• Collaborate closely with Preclinical, Regulatory Affairs and Medical Affairs to ensure tight strategic integration of product development plans.
• Be accountable via Clinical Research and Operations for all relevant timelines and deliverables.
• Supervise closely all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials.
• Be responsible for final review and sign off with respect to all controlled documents including protocols, IBs, informed consent forms.
• Influence internal and external audiences in a high impact, highly visible fashion.

Skills and Requirements:

• MD with strong research background or MD PhD, with best of class clinical and/or research training as shown through research support and peer review publications. Board Certification (or equivalent) or specialist training is highly desirable; drug development experience in rare diseases would be a great advantage, but not essential
• 3+ years industry experience or equivalent clinical academic experience
• Sound scientific and clinical judgment
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics, and regulatory agency organization, guidelines, and practices
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Outstanding leadership and collaboration skills working within a matrix environment.
• Experience and knowledge of working with biotech/pharma partner(s).
• Thrives in highly entrepreneurial biotech environment and embraces the company's culture of science, passion and urgency.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Russell on +44 203 8246 104 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.