Director Clinical Development

The Director, Clinical Development will be involved in multiple development projects at our client providing leadership to the organization focusing on the highest scientific integrity and standards, driving innovation and providing patient focused healthcare expertise

This role is responsible for ensuring alignment of supportive tactics for the emerging portfolio of products.

Responsibilities

• Participate in the development of product development plans and clinical trial strategy.
• Participate in the design and conduct of clinical trials and as a member of the clinical development team provide operational oversight by collaborating with internal and external operations personnel.
• Provide medical expertise regarding product development or other scientific issues for the clinical development team, drug discovery teams, and senior management.
• Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials.
• Participate in pharmacovigilance activities including SAE evaluation and reporting and analysis of safety data.
• Participate in preparation of protocols, Investigator Brochures, clinical study reports, safety reports, and the clinical sections of Annual Reports, INDs/IMPDs, NDAs/MAAs, SOPs, pediatric investigation plans, as well as abstracts and manuscripts
• Interface with regulatory agencies for clinical development programs and regulatory submissions when necessary.
  Oversee the scientific interaction with relevant medical consultants/ advisors and investigators.

Qualifications

Education Preferred:

• PhD, PharmD or MD degree with specialized training in neurology/epilepsy preferred

Work Experience:

• Some psychiatry drug development experience would be advantageous
• Practice experience preferable but not required
• Minimum of 3 years of experience in clinical development in the pharmaceutical industry, preferably with neurology compounds or relevant academic research experience