Senior Medical Director, Clinical Development

Overview:

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 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

Qualifications:

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

• 10% travel