The Senior 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.

General:

Training in Good Clinical Practices (GCP)
• Knowledge of relevant regulatory guidance for the clinical development process
• Experience with FDA and/or EMA preferred

Skills:

• Excellent cross-functional collaboration skills and must be able to work effectively in a team setting (including virtual teams)
• Evidence of ability to work with opinion leaders and clinical sites/investigators
• Excellent communication skills necessary to:
• Represent the Company externally in scientific presentations, conferences, industry groups and at Advisory Boards/Investigator Meetings
• Present to internal stakeholders including clinical and non-clinical audiences
• Interact with industry regulators
• Strong computer skills including MS office Suite (Word, Excel, PowerPoint, Outlook) and use of industry-standard software (e.g., electronic data capture systems) and proficient in data analysis software and data presentation

Responsibilities:

• Participate in the development of product development plans and lead clinical trial strategy for given project/program
• Participate in the design and conduct of clinical trials by providing oversight in collaboration with internal and external operations personnel (including CRO oversight for given projects/studies)
• Ensures projects/programs are delivered in compliance with GCP requirements and global ethical and regulatory standards
• Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials
• Provide medical expertise regarding product development or other scientific issues for drug discovery and development, and senior management
• 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

Education Preferred:

• M.D. Degree
• Practice experience preferable but not required

Work Experience:

• Minimum of 2 years of experience in clinical development in the pharmaceutical industry, preferably with neurology compounds or relevant academic research experience

Physical & Mental Requirements:

• Ability to multitask
• Adapts to change/flexible
• Maintain composure under pressure
• Ability to follow verbal or written instructions and use of effective verbal communication
• Examine and observe details
• Self-starter and decision maker

Other

• 10% travel