Principal Clinical Scientist

Terumo Group; Aliso Viejo (CA); On-site; USD 147,532 - 193,635; Full time

Job summary

Terumo Neuro is seeking a scientifically skilled professional to drive design, conduct, and reporting of clinical trials in assigned vascular therapy areas. You will interface with Medical Affairs, Regulatory, Clinical Research, R&D, and Marketing to support protocol development and study documentation.

Responsibilities include generating study-related documents, synthesizing literature, updating procedures, and contributing to regulatory submissions.

Responsibilities

• Provide scientific support for trial design and ongoing scientific analysis during protocol development.
• Lead creation of study documents including protocols, prior reports, and case report forms.
• Synthesize literature and competitive information across products within the therapeutic area.
• Update medical affairs procedural documents and submit change requests as needed.
• Generate documents to support regulatory submissions and respond to inquiries from authorities.
• Oversee data review and statistical analysis plans; contribute to publications and presentations.

Job description

Are you interested in working for an organization that is making a difference in people’s lives every day? We’re a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We’re a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what Terumo Neuro has to offer.
Provide scientific expertise for developing clinical evaluations, risk management, and /or clinical studies. Writes/manages clinical evaluation reports or clinical trial protocols clinical trial registrations and results postings and scientific publications. This position will drive scientific activities associated with the design, conduct and reporting of clinical trials for assigned therapeutic areas, interfacing with the Medical Affairs, Regulatory, Clinical Research, R&D, and Marketing departments. Typical duties might include:

• Provide scientific support to justify trial design and ongoing scientific analysis during protocol development, including generation of pre-protocol documentation of scientific information.
• Lead the generation of study-related documents and/or contribute content and oversight of such documents including clinical study protocols, reports of priors, investigational brochures, and case report forms.
• Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area.
• Responsible for updating medical affairs procedural documents and submitting change requests when needed.
• Generate documents to support regulatory submissions and/or respond to questions from regulatory authorities about existing submissions.
• Review and critically analyze clinical data and statistical analysis plans.
• Participation in scientific report writing. Presentation of methods, results and conclusions to a publishable standard. Lead study level publication planning.
• Support the generation of white and position papers by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
• Lead publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts.
• Contribute to the optimization of internal processes and workflows.
• Assist the medical director with direct customer interactions as needed.

Job ID 14129BR

Salary Range:

$147,532 - $193,635 (Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand).