Medical Director, Clinical Development

SK Life Science, Inc

Medical Director, Clinical Development

Paramus ,

New Jersey

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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.
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 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
Other
10% travel

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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