Neurologist Opportunity - Biotech Clinical Development

Barrington James; Italia; In loco; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading company in clinical development seeks a Medical Director with strong scientific expertise and collaboration skills. The role includes planning clinical trials in psychiatry/neurology and requires substantial experience in clinical development and knowledge of regulatory guidelines.

Competenze

• Minimum of 5 years of experience in biotech, pharma, CROs, or academia.
• Proven experience in clinical trials or research.
• Experience in authoring protocols, study reports, and IBs.

Mansioni

• Responsible for planning and executing clinical trials in psychiatry and/or neurology.
• Support day-to-day operations and projects in the Clinical Development department.
• Work closely with various departments like CROs, CMC, and regulatory bodies.

Conoscenze

Effective oral and written communication skills

Interpersonal skills

Scientific expertise

Collaboration skills

Formazione

MD in Psychiatry or Neurology

PhD in Neuroscience

Descrizione del lavoro

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 the development of key study programs, reporting directly to the CMO and VP of Clinical.

• Responsible for the planning and execution of clinical trials in psychiatry and/or neurology, including selecting investigation sites and ensuring the medical/scientific validity and integrity of the clinical development program and study protocols.
• Depending on experience and the level of the drug program, this individual may lead one or more clinical trials and may serve as the clinical lead for a specific drug program.
• Support, track, and assist with day-to-day operations and projects within the Clinical Development department. Play a key role in working with other project team members to prepare documents for IRBs/ECs and regulatory authorities, and assist in responding to queries from these entities.
• Work closely with clinical operations, CROs, CMC, pharmacovigilance, and regulatory departments.
• Stay informed of scientific and clinical advances, professional information, and technology through conferences and medical literature.

Qualifications and Education Requirements

• Preferably an MD in Psychiatry or Neurology, or a PhD in Neuroscience.
• Minimum of 5 years of experience in biotech, pharma, CROs, or academia.
• Previous experience in clinical trials or research.
• Experience participating in international project teams.
• Willingness to travel within the US to clinical sites; some travel to ex-US locations may be necessary.
• Experience in authoring protocols, study reports, and IBs.
• Effective oral and written communication skills.
• Experience assisting with data management, statistics, clinical operations, and reviewing/interpreting clinical trial data.
• Comprehensive understanding of pharmaceutical drug development and excellent knowledge of GCP, FDA, EMA, and ICH guidelines.
• Excellent interpersonal skills for interacting with individuals from diverse cultures and disciplines.

For more information, please apply with a cover letter detailing your relevant experience.