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.
