Clinical Development Director Cns Milano

Clinical Development Director Cns
Milano
Lombardia, Milano

My client is a CNS Drug Development specialist, focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain.

I am exclusively partnered with this company to search for a Clinical Director to plan and execute clinical trials in CNS on a global scale.

The position reports to the VP Clinical Operations for direct guidance and the CMO for medical issues.

If you are a Medical Doctor with at least 5 years of experience in CNS clinical trials, keep reading. . .

**Responsibilities**:

- The individual will be responsible for the planning and execution of clinical trials in psychiatry, and/or neurology, selecting investigational sites in the US and, if necessary, in the ROW)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.

- 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 up to date on scientific and clinical advances, professional information, and technology through conferences and/or medical literatures.

**Requirements**:

- MD/MBBS/MBChB

- Minimum 5 years of experience in Biotech/Pharma/CRO/Academia in Neuroscience

- Worked previously in clinical trials/research in Psychiatry

- Experience in participating in international project teams

- Willingness to travel extensively 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

- Comprehensive understanding of pharmaceutical drug development, with excellent working knowledge of good clinical practices and associated FDA, EMA, and ICH guidance in drug development

- Competent knowledge of standard office-based software (i. e.

Microsoft Office)

- Excellent interpersonal skills - interaction with individuals from a variety of cultures and disciplines

- Fluency in English

- **Must be based in Milan or able to commute frequently (3 weeks per month on-site)

Please click 'apply' or contact Mollie Laurens-Chalmers for any further information.

**Job Types**: Full-time, Permanent

**Salary**: €90, 000. 00 - €120, 000. 00 per year

Work Location: One location