Director of Clinical Development

Proclinical is currently seeking a Director of Clinical Development for a pharmaceutical company located in New Jersey. Successful candidate will serve as the medical/clinical sciences lead and is responsible for co-developing the CDP in accordance with the project strategy. Primary role for this position involves managing and successful execute late phase clinical trials in orphan indication.

Job Responsibilities:

• Providing scientific, technological and medical knowledge and expertise for the clinical research aspects of the project and providing clinical and therapeutic expertise to the development of the project strategy and the clinical development plan.
• Serving as the clinical research representative for products in development at strategic meetings or advisory boards.
• Providing medical and scientific input to the core documents for the project.
• Developing, executing and regularly maintaining the project CDP and other relevant clinical documents that are consistent with the project goals.
• Consulting with internal/external stakeholders and internal/external key opinion leaders to validate the scientific and medical components of the CDP.
• Participating as lead clinical representative on cross-functional project team.
• Supporting clinical study and operational teams.
• Providing medical and scientific interpretation of efficacy and safety data; and seeking advice of other experts as required.
• Providing input for a project publication plan, liaising with commercial and work on launch activities when required.
• Helping to identify additional opportunities within the broad R&D portfolio; proposing indication and study design approaches for establishing proof of concept and helping identifying and evaluating opportunities for in-licensing or mergers/acquisitions that would expand the platform portfolio.
• Reviewing abstracts and manuscripts created by internal or external sources.

Skills and Requirements:

• US licensed MD or equivalent qualification preferred; PharmD or PhD also acceptable.
• 5+ years' experience in clinical research (preferred Phase 2-3trials) gained working for a pharmaceutical, biotechnology or CRO company.
• Demonstrated ability to manage multiple and diverse projects concurrently.
• Demonstrated ability to develop relationships and generate collaborations.
• Solid medical/scientific writing skills required with appropriate clinical, scientific and medical knowledge to author and design and implement clinical protocol and other study documents.
• Experience with the operational aspects of clinical trials and related activities such as investigator meetings, DSMB's, and GCP/ICH are necessary.
• Excellent written and oral communication skills and a command of the English language are a must.
• Organizational and cross functional collaboration skills.
• Approximately 10 to 25% domestic and international travel is required.
• Proficient in Microsoft 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 call Miles Tobin at (+1) 617-545-5922 or upload your resume 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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