Director Medical Monitor, Neurology

Proclinical is currently recruiting for a Director Medical Monitor of Neurology for a pharmaceutical company located in Princeton, NJ. Successful candidate will develop clinical synopsis, protocols and amendments, investigator brochures, and clinical study reports.

Job Responsibilities:

• Lead strategic planning for clinical development programs.
• Lead clinical study team and provide appropriate medical monitoring for clinical studies.
• Evaluate pharmacology, safety and efficacy data from ongoing and completed studies.
• Conduct literature reviews and prepare summaries to support clinical development programs.
• Be medical resource for design and interpretation of clinical and preclinical programs to support existing and new development pipelines.
• Evaluate potential business development opportunities and conduct due diligence for assessing scientific, medical and development feasibility.
• Interact with key opinion leaders related to assigned compounds and therapeutic area.
• Contribute to NDA and MAA filings and prepare relevant sections of the regulatory documents.

Skills and Requirements:

• 2-5+ years' Industry Experience in Clinical Development.
• MD required.
• Clinical practice experience; Board certification, neurology or psychiatry preferred.
• Strong leadership skills, and ability to lead clinical team and work effectively with cross functional teams and leaders.
• Superior communication, interpersonal and negotiating skills to interact with internal leadership team, external partners and investigators/medical professionals.
• Team spirit.
• Global perspective and mindset, ability to work effectively with colleagues from myriad cultures, backgrounds and geographies.
• Ability to proactively look into issues and solve problems.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
• Knowledge in FDA, EMA, JMPD and other regulatory requirements, GCP/ICH.

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 Nicole Aganon at (+1) 347-293-1161 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.

Proclinical Staffing is an equal opportunity employer.

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