Clinical Development Director

A leading biotechnology research organization is seeking to recruit a Clinical Development Director. Based in Pennsylvania, this establishment is renowned for their focus on developing next-generation gene transfer vectors and their application in the treatment of a variety of acquired and inherited diseases. This position offers an exciting opportunity to work with a company that is riven by the unmet needs of patients with genetic diseases.

Job Responsibilities:

• Designing end-to-end clinical development plans for multiple programs.
• Providing clinical and translational leadership to drive the design of natural history studies and early phase clinical trials.
• Closely collaborating with the relevant rare disease experts, preclinical safety pharmacology lead, biomarkers and imaging specialists, and the Clinical Operations lead.
• Working closely with other functional experts to progress research projects to IND readiness.
• Being accountable for the design, implementation, and effective conduct of non-interventional natural history studies and patient registries.
• Contributing to the development of regulatory briefing documents, clinical protocols, and clinical elements of regulatory submission documents.
• Developing an external key opinion leader network and relationships with patient advocacy groups to bring scientific, patient, and medical expert insight to development programs.

Skills and Requirements:

• Master's Degree in life sciences or equivalent experience.
• 2+ years' experience in clinical trial management.
• Hands-on experience in global clinical trial conduct and operations.
• Demonstrable ability to deliver clinical studies on time and on budget.
• A detailed knowledge of GCP and other regulations governing clinical studies
• Rare diseases experience highly desirable.
• 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 Mary Jacobs at +1 267-477-4800 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.

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