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Senior Director, Medical Strategy CNS


Senior Director, Medical Strategy CNS
Scientific Search client has an immediate need for a Sr. Director, Medical Strategy. This is a full time perm position with a dynamic organization, in the Ridgewood, NJ area.
SUMMARY OF POSITION
Medical Strategy, CNS will be a member of multiple product teams at SK Life Science. The incumbent will provide neuro-therapeutic and pharmacovigilance expertise to the clinical development of the SKLSI pipeline of neuro-therapeutic drugs. He/she will also provide clinical operational support to each product team developing the SKLSI pipeline. The position will report to the Chief Medical Officer of SK Life Science.
JOB REQUIREMENTS
General
Training in Good Clinical Practices (GCP)
Knowledge of relevant regulatory guidance's for the clinical development process.
Experience with assembling an NDA, preferably for a neuropsychiatric product
Experience with FDA interactions
Skills
Evidence of ability to establish network with opinion leaders
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 regulators.
Experience in writing clinical protocols including knowledge of basic clinical trial design and statistical concepts
Experience with writing Clinical Study reports, Integrated Summaries of safety and efficacy

Education:
M.D. degree with specialized training in central nervous system diseases, neurology preferred
Practice experience preferable but not required
Experience:
Minimum of 10 years' experience in clinical development in the pharmaceutical industry, preferably with drugs for neurological disease (Phase 1-3)








TASKS AND RESPOSIBILITIES
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 team provide operational oversight by collaborating with internal and external operations personnel.
Provide medical expertise regarding product development or other scientific issues for the clinical development team, drug discovery teams, 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/ advisors and investigators. .




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