Senior Manager, Scientific Affairs

Job Locations US-CA-Redwood City
Job Post Information* : Posted Date 1 month ago(10/8/2024 1:03 PM)
ID
2024-4638
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 leading Nevro’s publication strategy and supporting clinical research initiatives. This role shall manage the medical writing needs for peer reviewed publications, regulatory deliverables and scientific communications. Focus on developing, managing and executing publication pipeline for Nevro therapy, supporting design of clinical studies analyzing and disseminating the generated evidence.

 

Publications/Medical Writing

  • Lead Nevro’s scientific publications strategy, key initiatives/global evidence communications and develop annual publication plans in collaboration with key global stakeholders
  • Lead tactical execution of publication plans (ie, clinical manuscripts, abstracts, posters, and oral presentations), meeting established timelines and budgets.
  • Manage and supervise medical writers (internal/external) including contractual aspects, onboarding and engagement.
  • Collaborate with clinical, regulatory and commercial organizations to support scientific publications and regulatory deliverables.
  • Support the upkeep of the clinical research reference library including developing structure for indexing
  • Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments
  • Support the marketing team to curate competitive intelligence, to create social media assets and support distribution of published evidence
  • Lead collaborations with KOLs and medical experts to plan and execute strategic/technical publications

Clinical Research

  • Organize and analyze data from clinical research studies.
  • Plan for, and participate in clinical research meetings.
  • Collaborate with clinical project/program managers and data management team.
  • Participate in the dissemination of clinical information to the clinical team members and extended core team members, as appropriate.
  • Represent Nevro at conferences and present clinical data.
  • Provide feedback and support regulatory submissions for US/OUS market access, especially technical documentation including Clinical Evaluation Reports (CER), Post Market Clinical Follow Up (PMCF) plans etc.
  • Communicating with internal and external collaborators on executing scientific proposals including sponsored studies, investigator-initiated studies etc.
  • Interact with internal /external audit stakeholders, regulatory agencies’ representatives etc. as needed.
  • Other duties as assigned.

Role Requirements

  • MS. or Ph.D. Degree in science/health/engineering (e.g., Neuroscience, and/or Biomedical Engineering preferred). 
  • 5+ years’ experience in clinical/scientific research, medical devices/pharmaceutical clinical trials, plus 2+ years’ experience working in medical writing.

 

Skills and Knowledge

  • Strong data analysis skills including proficient use of Excel, statistics tools, Adobe Illustrator.
  • Good understanding of the medical concepts, terminology and spinal cord stimulation.
  • Understanding of US/OUS regulatory affairs. RAC certification is a plus.
  • 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.
  • Experience managing KOL relationships

Target Pay Range

$161,779 - $202,224 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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