Principal Clinical Research Scientist

Job Locations US-CA-Redwood City
Job Post Information* : Posted Date 5 days ago(11/18/2024 12:50 PM)
ID
2024-4706
Category
Clinical & Regulatory

About Nevro

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally.  

 

Nevro’s comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy.  Senza®, Senza II®, Senza Omnia™, and Senza HFX iQ™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. HFX iQ, Nevro’s latest innovation, is the first and only SCS System that uses Artificial Intelligence to optimize and maintain pain relief using each patient's response1.Nevro’s unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management. 

 

Nevro also recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ("SI joint") pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients.

Job Summary & Responsibilities

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.

Role Requirements

  • 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

 

Skills and Knowledge

  • 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

Target Pay Range

$196,182 - $245,227 The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, alignment with market data, and geography. *Nevro is a multi-state employer, so the target pay range may increase or decrease depending on the city/state.

Full-time Nevro team members enjoy a full suite of additional benefits such as market-leading medical, dental, and vision benefits, 401k matching, ample vacation time, pre-tax savings perks, tuition reimbursement, Employee Stock Purchase Plan (ESPP), short and/or long-term incentive opportunities, recognition awards, volunteer time off, and several employee resource groups that focus on supporting our Wellness, Leadership Development, and Diversity and Inclusion.

EEO Statement

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, protected veteran status, disability, age or other characteristics protected by laws.

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