Medical Director, Clinical Development
2 weeks ago
Medical Director, Clinical Development
Job Locations
US-NJ-Paramus
ID
2024-1814
Category
Medical Affairs
Type
Regular Full-Time
Overview
SK Life Science (SKLSI) is seeking an experienced Director of Clinical Development-CNS to be involved in multiple product development projects. Working with cross-functional teams, the Director of Clinical Development will provide therapeutic and pharmacovigilance expertise to the clinical development of the SKLSI pipeline of therapeutic drugs with particular focus on epilepsy. The Director will partner closely with clinical operations to support each product development project. The Director will work with regulatory, discovery, business development, legal, quality and CMC to facilitate the development of SK Life Science products.
Responsibilities
General:
- Training in Good Clinical Practices (GCP)Knowledge of relevant regulatory guidance for the clinical development processExperience 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/investigatorsExcellent communication skills necessary to:Represent the Company externally in scientific presentations, conferences, industry groups and at Advisory Boards/Investigator MeetingsPresent to internal stakeholders including clinical and non-clinical audiencesInteract with industry regulatorsStrong 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/programParticipate 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 standardsProvide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trialsProvide medical expertise regarding product development or other scientific issues for drug discovery and development, and senior managementParticipate in pharmacovigilance activities including SAE evaluation and reporting and analysis of safety dataParticipate 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 manuscriptsInterface with regulatory agencies for clinical development programs and regulatory submissions when necessaryOversee the scientific interaction with relevant medical consultants/advisors and investigators
Qualifications
Education Preferred:- M.D. Degree
- Practice experience preferable but not requiredWork Experience:
- Minimum of 2 years of experience in clinical development in the pharmaceutical industry, preferably with neurology compounds or relevant academic research experiencePhysical & 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 makerOther
- 10% travel
- 10% travel
- Minimum of 2 years of experience in clinical development in the pharmaceutical industry, preferably with neurology compounds or relevant academic research experiencePhysical & Mental Requirements:
- Participate in the development of product development plans and lead clinical trial strategy for given project/programParticipate 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 standardsProvide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trialsProvide medical expertise regarding product development or other scientific issues for drug discovery and development, and senior managementParticipate in pharmacovigilance activities including SAE evaluation and reporting and analysis of safety dataParticipate 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 manuscriptsInterface with regulatory agencies for clinical development programs and regulatory submissions when necessaryOversee the scientific interaction with relevant medical consultants/advisors and investigators
- 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/investigatorsExcellent communication skills necessary to:Represent the Company externally in scientific presentations, conferences, industry groups and at Advisory Boards/Investigator MeetingsPresent to internal stakeholders including clinical and non-clinical audiencesInteract with industry regulatorsStrong 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:
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Paramus, United States SK Life Science, Inc. Full timeSenior Medical Director, Clinical Development Job Locations US-NJ-Paramus ID 2024-1814 Category Medical Affairs Type Regular Full-Time Overview SK Life Science (SKLSI) is seeking an experienced Director of Clinical Development-CNS to be involved in multiple product development projects....
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