Job Description

The Director of Clinical Development CNS will be involved in multiple product development projects at SK Life Science (SKLSI). He-she will provide therapeutic and pharmacovigilance expertise to the clinical development of the SKLSI pipeline of therapeutic drugs with particular focus on epilepsy. He/she will also provide clinical operational support to each product development projects. The Director will work with regulatory, discovery, business development, legal, quality and CMC to facilitate the development of SK Life Sciences products. The position will report to the Chief Medical Officer of SK Life Science.

Responsibilities

General

• Training in Good Clinical Practices (GCP)
• Knowledge of relevant regulatory guidance for the clinical development process
• Experience with FDA preferred
• Reports to Chief Medical Officer

Skills

• Evidence of ability to work with opinion leaders, principal investigators
• Must be able to work effectively in a team setting
• Communication skills necessary to:
  • Represent the Company externally in scientific presentations, conferences and industry groups;
  • Present to internal stakeholders
  • Interact with industry

Responsibilities:

• Participate in the development of product clinical 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 clinical operations personnel
• Provide medical expertise regarding product development or other scientific issues for drug discovery and development
• 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 documents including but not limited to: 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, regulatory submissions, and GCP inspections when necessary
• Oversee the scientific interaction with relevant medical consultants/advisors and investigators

Qualifications

• M.D. degree
• 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
• Ability to multitask
• Adapts to change
• Maintain composure under pressure
• Ability to follow verbal or written instructions and use of effective verbal communications
• Adapts change, adjust change and grasps information quickly
• Examine and observe details
• Self starter and decision maker
• 10-20% travel