Senior Director / Director Clinical Scientist CNS BioTec

Compensation

: $132,420.00 - $206,040.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



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An exciting opportunity has just emerged with a cutting-edge biotech focused on the development of innovative, novel gene therapies for disorders of the central nervous system.
The purpose of the Senior / Director Clinical Scientist is to support the project teams with design and implementation of clinical studies. These duties include but are not limited to protocol level plans, database updates, preparation of regulatory agency documents, clinical supplies training, safety and medical monitoring.
Responsibilities: Creating and authoring clinical sections of clinical study reports, protocols, regulatory agency reports, other regulatory documents. Monitoring of study execution and development planning for compounds assigned Preparation of clinical study report and protocol documents as well as other key documents (Investigator Brochures, internal or external presentations, regulatory submissions, SOPs etc.) Interaction with internal and external stakeholders to support clinical trial objective including interaction with vendors, study sites, committees, and investigator meetings.
Qualifications: Doctorate degree in life sciences or a related field and 5+ years in clinical research or drug development. Pharmaceutical/Biotech industry experience is required. Required experience in CNS or Neurology. Gene Therapy experience is preferred but not required. A successful track record and understanding of the clinical research process from beginning to end of the product lifecycle. Ability to work cross-functionally and collaboratively within teams. Knowledgeable in GCP, ICH, and FDA guidelines.
Contact Details: Full job description and company details are available upon application. This position is being dealt with by Kaitlyn Sumner at Meet. You can connect wither her directly at ...@peoplewithchemistry.com to discuss further and in confidence. You can find out more about Kaitlyn & Meet at www.peoplewithchemsitry.com
Associated topics: drug discovery, fellow, fellowship, laboratory, phd, professor, research, research fellow, scientist, toxicologist * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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