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Executive Director, Psychiatry

SK Life Science Inc

This is a Contract position in Paramus, NJ posted March 31, 2020.

The Executive Director of Clinical Development Psychiatry 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 Must be able to work effectively in a team setting or in a supervisory capacity 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 development plans and clinical trial strategy Participate in the design and conduct of clinical trials and as a member of the Clinical Development/Medical Affairs provide operational oversight by collaborating with internal and external operations personnel Provide medical expertise regarding product development or other scientific issues for drug discovery and development, and senior management 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 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 / advisor s and investigators Qualifications Education MD.

degree with specialized training in Psychiatry required Practice experience preferable but not required Work Experience Minimum of 6 years of experience in clinical development in the pharmaceutical industry , preferably with Psychiatric compounds or relevant academic research experience Sorry the Share function is not working properly at this moment.

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