Neurologist / Psychiatrist - Clinical Development

Neurologist / Psychiatrist - Clinical DevelopmentNeurologist / Psychiatrist - Clinical Development

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The Role : Medical Director Clinical Development

This is a highly strategic and multifaceted role requiring both scientific expertise and strong collaboration skills. You will be at the forefront of shaping development of a key study program reporting directly to the CMO and VP Clinical.

• Responsible for the planning and execution of clinical trials in psychiatry, and / or neurology, selecting investigational sites and for ensuring the medical / scientific validity and integrity of the clinical development program and clinical study protocols.
• Depending on the experience and the level of drug program the selected individual may lead one or more clinical trials and may be the clinical lead of a specific drug program.
• Support, track, and assist day-to-day operations and projects for the Clinical Development department and will play a key role, working with other members of the project team in preparing documents for IRBs / ECs, and regulatory authorities and assist in responding to queries from any of these committees / regulatory authorities.
• Work closely with clinical operations, CROs, CMC, pharmacovigilance and regulatory department.
• Keep abreast of scientific and clinical advances, professional information, and technology through conferences and / or medical literatures.

Qualifications and Education Requirements

• Preferably an MD in Psychiatry / Neurology, or a PhD in Neuroscience
• Minimum 5 years of experience in Biotech / Pharma / CROs / Academia
• Worked previously in clinical trials / research,
• Experience in participating in international project teams
• Willingness to travel in the US to clinical sites; some travel to ex-US locations necessary
• Previous experience in authoring protocols / study reports / IBs
• Effective oral and written communication skills
• Experience assisting data management, statistics, clinical operations and reviewing / interpreting clinical trials data
• Comprehensive understanding of pharmaceutical drug development, with excellent working knowledge of good clinical practices and associated FDA, EMA, and ICH guidance in drug development.
• Excellent interpersonal skills – interaction with individuals from a variety of cultures and disciplines

For more information, please apply with some covering information, detailing your relevant experience.

Seniority level

• Seniority levelDirector

Employment type

• Employment typeFull-time

Job function

• Job functionManagement, Strategy / Planning, and Science
• IndustriesPharmaceutical Manufacturing and Biotechnology Research

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