Principal Clinical Research Scientist at Nevro in Redwood City, California

Job Description:

Principal Clinical Research Scientist

US-CA-Redwood City

Job ID: 2024-4706
Type: Regular Full-Time
# of Openings: 1
Category: Clinical & Regulatory
HQ

Overview

This position will be responsible for defining research strategies, leading clinical trial design, and executing clinical studies in concert with internal and external resources. This role shall demonstrate leadership in clinical research activities, drive engagement in product development, define clinical strategy for regulatory approvals/market access, and contribute towards clinical lifecycle management including dissemination of the generated clinical evidence.

This is a critical role within Clinical Research function at Nevro with high visibility to the Executive team and scope for significant contributions to the business, as it requires liaison with Chief Medical Officer, R&D, Marketing, Market Access, Regulatory, and Commercial to produce high quality clinical evidence and influence patient care. The successful candidate has an opportunity to solve complex challenges in neuromodulation, collaborate across functional teams, and provide subject matter expertise.

Responsibilities

Clinical Research

• Provide leadership for design, development, and conduct of new clinical initiatives to drive regulatory approvals for Nevro’s therapies
• Develop and review protocols for projects, both sponsored and investigator-initiated
• Contribute and assist with development of case report forms, informed consent, regulatory deliverables including clinical study reports, clinical evaluation reports etc.
• Interpret results for safety, effectiveness, clinical utility, and marketability of Nevro products
• Organize and analyze data from clinical research to build new hypothesis

Collaboration & KOL Management

• Engage and collaborate with physicians on design and implementation of feasibility & new indication clinical studies
• Assist in planning for, and participate in investigator and coordinator meetings, representing the therapeutic area or region
• Lead physician advisory boards and KOL focus groups to gather feedback on clinical studies, state of the art, regulatory strategies, and new clinical initiatives

Education & Research Dissemination

• Lead development and preparation of abstracts, posters, manuscripts, literature search and assist and/or present scientific findings and activities at conferences
• Participate in the dissemination of clinical information to the clinical team members and extended core team members, as appropriate
• Represent Nevro at scholarly sessions, trade events, conferences, regulatory meetings, and customer meetings
• Collaborate and educate clinical project/program managers and clinical operations staff as Nevro’s subject matter expert
• Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments
• Other duties as assigned.

Responsibilities

• M.S. or Ph.D. Degree in science/health/engineering (e.g., Neuroscience, and/or Biomedical Engineering preferred). Candidates with other advanced degrees (MD, RN, MSN, PharmD etc.) coupled with relevant industry clinical research experience are also encouraged to apply
• 7+ years’ experience in clinical/scientific research, medical devices/pharmaceutical clinical trials, and medical writing
• Solid publication record, ideally in the field of neuromodulation/spinal cord stimulation. Other relevant areas of medical device experience includes diabetes, oncology and cardiology
• Track record of developing clinical initiatives in concert with physician thought leaders, clinical project management spanning feasibility, pivotal (IDE/post market) studies
• Technical acumen, strong interpersonal skills, and exceptional executive communications
• May require up to 20% of travel (domestic/international)
• Work with minimal supervision and a self-starter

Qualifications

• Understanding of research methodology, medical device regulations (US/OUS) and guidelines (ISO14155; MEDDEV 2.7/1 Rev 4 etc.), and product knowledge, to support technical documentation for CE Marking
• Relevant experience in research methodology, scientific literature review (PUBMED, EMBASE, MEDLINE etc.) for safety, effectiveness, and state of the art, and appraisal of clinical data.
• Experience managing KOL relationships

• Understanding of the medical concepts, terminology and neuromodulation/spinal cord stimulation is a plus
• Background in biostatistics preferred

• Understanding of US/OUS regulatory affairs (FDA 21 CFR 812, EU MDR etc.)

• Project Management Certification (preferably PMI) is a plus

Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, disability, age or other characteristics protected by laws.

PI255178303

Salary:

$196,182.00

Apply Now