Principal Clinical Scientist

Terumo Neuro; Aliso Viejo (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Terumo Neuro is seeking a Principal Clinical Scientist to provide scientific expertise for clinical evaluations, risk management, and studies across neuroendovascular technologies. You will drive design, conduct, and reporting of trials, interfacing with Medical Affairs, Regulatory, Clinical Research, R&D, and Marketing.

The role emphasizes leadership with executives, clinical protocol development, literature synthesis, and preparation of regulatory submissions.

Qualifications

• Must have a master's degree in a relevant science, medicine, or similar discipline.
• Must have at least five (5) years of relevant clinical research scientist experience.
• Knowledge of Good Clinical Practices (GCP) is required.
• Excellent writing and editing skills, and a keen attention to detail.
• Strong verbal, written, and interpersonal communication skills.
• Clinical protocol development experience.
• Expertise in conducting focused literature searches on PubMed, MedLine or other medical literature databases.
• Proven analytical skills working with clinical or research data.

Responsibilities

• Provide scientific support to justify trial design and ongoing scientific analysis during protocol development.
• Lead the generation of study-related documents including clinical study protocols and reports.
• Synthesize literature across products/therapies within the area.
• Update medical affairs procedural documents and submit change requests as needed.
• Generate documents to support regulatory submissions or respond to regulatory questions.
• Review and analyze clinical data and statistical analysis plans.
• Participate in scientific report writing and lead study-level publication planning.
• Support white papers and position papers by evaluating literature and data.
• Lead publications for clinical study data with investigator authors and management of revisions.
• Contribute to optimization of internal processes and workflows.
• Assist the medical director with direct customer interactions as needed.

Skills

Leadership

GCP knowledge

Scientific writing

Communication

Clinical protocol

Literature review

Data analysis

Education

Master's degree in relevant science/medicine

PhD with 3+ years clinical research experience

Job description

14129BR

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.

Qualifications:

1. Must have a master's degree in a relevant science, medicine, or similar discipline.

2. Must have at least five (5) years of relevant clinical research scientist experience.

3. Strong leadership skills since position requires significant interaction with executive leadership, physicians and regulatory authorities.

4. Knowledge of Good Clinical Practices (GCP) is required.

5. Excellent writing and editing skills, and a keen attention to detail.

6. Strong verbal, written, and interpersonal communication skills.

7. Clinical protocol development experience.

8. Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases.

9. Proven analytical skills working with clinical or research data.

Desired Qualifications

1. PhD with a minimum of three (3) years' experience in clinical research.

2. Experience as author or contributor or peer-reviewed manuscripts is strongly desired.

3. Knowledge of patient safety, quality, clinical research, strategic planning, health biostatistics or epidemiology is desired.

4. Experience interacting with FDA or China regulatory agencies highly preferred.

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

Posting Country:

US - United States

Title:

Principal Clinical Scientist

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.