Senior Director, Clinical Development - Oncology - SK Life Science Labs
sklifescienceinc
FULL TIME
Medical Director, Clinical Development - CNS
sklifescienceinc· Clinical Operations
About this role
Overview
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
Frequently Asked Questions
Is the salary disclosed for the Medical Director, Clinical Development - CNS position at sklifescienceinc?
The salary for this Medical Director, Clinical Development - CNS role at sklifescienceinc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Medical Director, Clinical Development - CNS position at sklifescienceinc located?
This Medical Director, Clinical Development - CNS role at sklifescienceinc is based in Paramus, NJ, US. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Medical Director, Clinical Development - CNS role at sklifescienceinc full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Medical Director, Clinical Development - CNS role in the Clinical Operations department at sklifescienceinc.
Which team or department does the Medical Director, Clinical Development - CNS at sklifescienceinc belong to?
This Medical Director, Clinical Development - CNS position is part of the Clinical Operations department at sklifescienceinc. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Medical Director, Clinical Development - CNS position at sklifescienceinc?
Click the "Apply Now" button on this page. You will be redirected to sklifescienceinc's official application portal hosted on icims where you can submit your application directly.
When was the Medical Director, Clinical Development - CNS job at sklifescienceinc posted?
This Medical Director, Clinical Development - CNS position at sklifescienceinc was posted on Jun 12, 2024. Apply as soon as possible — early applications are often reviewed first.
Medical Director, Clinical Development - CNS
sklifescienceinc
You'll be redirected to sklifescienceinc's official application page on icims.