Clinical Development Medical Director
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A leading biotechnology company is seeking to recruit a Clinical Development Medical Director - Rare Diseases/Gene Therapy to their office in London. The company is known for their work in developing therapeutics that treat rare genetic diseases, some of which affect as few as 1000 people worldwide. This is an exciting opportunity to join a dynamic global business and support its commercial presence across Europe, along with other regions.
Job Responsibilities:
- Design and maintain clinical development plan.
- Design and write clinical protocols, clinical sections of regulatory submissions, and clinical study reports.
- Provide clinical leadership and medical monitoring for human clinical trials.
- Develop and maintain relationships with academic thought leaders.
- Design and initiate strategically meaningful investigator-initiated studies.
- Provide input on due diligence assignments evaluating in-licensing or acquisition targets.
- Contribute to the peer review process, both internally and externally, to help assure the company clinical science is conducted at the highest level of quality, integrating business, and development objectives.
- Interact with key opinion leaders to assure implementation of latest clinical thinking and guidelines into the clinical development plan.
- Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants, and contract resources.
- Represent the company at scientific, commercial, and financial community meetings and presentations, as well as other public relations opportunities.
- Attend and provide scientific support for investigator and consultant meetings and other study implementation workshops.
- Participate in management of studies and serve as expert on clinical and medical issues to other colleagues and study site staff.
- Participate in medical monitoring and the review of study data.
- Assist in the development of publications, abstracts, and presentations.
- Provide clinical input into design and endpoints for relevant nonclinical, translational proof of principle animal studies.
- Provide internal clinical leadership by distilling and communicating translational research concepts and clinical management strategies to multi-disciplinary scientific and non-scientific project teams.
- Provide clinical input and partnering with research on IND candidate selection, supporting pre-clinical pharmacologic and toxicology studies to support human clinical studies.
- Develop relevant clinical and molecular biomarkers for nonclinical and clinical studies.
Skills and Requirements:
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Tom Russell at +44 203 824 6104 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.
Proclinical Staffing is an equal opportunity employer.
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