SK Life Science, Inc.
Medical Director, Clinical Development - CNS
The Director of Clinical Development CNS will provide therapeutic and pharmacovigilance expertise to clinical development projects, focusing on epilepsy. The role involves clinical operational support, collaboration with multiple departments, and oversight of clinical trials and pharmacovigilance activities.
Key Responsibilities
- • Training in Good Clinical Practices (GCP)
- • Knowledge of relevant regulatory guidance for the clinical development process
- • Participate in the development of product clinical development plans and clinical trial strategy
- • Participate in the design and conduct of clinical trials and 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
- • Represent the Company externally in scientific presentations, conferences and industry groups
- • Present to internal stakeholders
- • Interact with industry
Required
- • M.D. degree
- • Minimum of 3 years of experience in clinical development in the pharmaceutical industry, preferably with neurology compounds or relevant academic research experience
- • Training in Good Clinical Practices (GCP)
- • Knowledge of relevant regulatory guidance for the clinical development process
- • Ability to multitask
- • Adapts to change
- • Maintain composure under pressure
- • Ability to follow verbal or written instructions and use of effective verbal communications
- • Examine and observe details
- • Self starter and decision maker
- • 10-20% travel
Preferred
- • Practice experience preferable but not required
- • Experience with FDA preferred
- • Evidence of ability to work with opinion leaders, principal investigators
- • Must be able to work effectively in a team setting
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
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
- 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
- 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
- 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
Keep track of your job search
Save personal notes for each job to track your thoughts, application status, and follow-ups.
Try for freeUpload your resume
Sign up to upload your resume and get AI-powered customization for job applications.
Sign up freePractice your interview
Get AI-powered mock interviews tailored to this Medical Director, Clinical Development - CNS role. Upload your resume and practice with real-time voice feedback.
Sign up to practice