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Scientist II, Clinical Job

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Date: Dec 3, 2018

Location: Valencia, CA, US, 91355

Company: Boston Scientific

Additional Locations: (n/a)

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

About the role:

The Clinical Scientist provides Neuromodulation therapeutic area expertise inclusive of competitive landscape to assess the clinical safety and performance/efficacy of medical devices to develop strategies for clinical trial design, regulatory submissions, publications, and to monitor the risk to benefit ratio of products over their lifecycle to yield improved device design for worldwide product support. Provides strategic direction for clinical trial and non-clinical trial options and leads strategic decisions related to clinical evidence to support product development.  Collaborates with various internal (Clinical Project Management, Regulatory, Clinical Communication, Clinical Medical Director, R&D, Marketing, Quality and Clinical Biostatistics) and external experts or agencies to assist in clinical/non-clinical strategy, the development of study designs, scientific publications and product design.

 

Your responsibilities will include:

  • Provides clinical trial and non-clinical trial strategic direction within Neuromodulationscientific, therapeutic areas inclusive of competitive landscape and medical device expertise.  Provides clinical input for new product development, post-market surveillance, recertification, business development and may support due diligence assessments.
  • Author worldwide pre-market and post market clinical trial protocols/designs and regulatory reports in support of mandated post market requirements, product approval, indication expansion and label claim support.
  • Support Product Development Teams in the evaluation of Product Risk and Design Control Process. Ensure Clinical accuracy of harms in Hazard Analysis, product FMEA and DFU/IFU. Author Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms, and support of safety and performance for product approval. Ensure linkage between clinical harms identified in Clinical Evaluations and Risk Analysis throughout the product lifecycle.
  • Author manuscripts and abstracts for submission and publication in peer reviewed scientific journals.  Author slide presentations, and poster presentations for scientific meetings/congresses worldwide.
  • Build and maintain strong relationships with internal and external scientific, technical and organizational leaders to support clinical and product strategies including study and site clinicians and investigators.
  • Present as needed to worldwide regulatory agencies, investigational meetings, Data Monitoring Committee (DMC), Regional Advisory Boards, Medical Advisory Board (MAB), Safety Advisory Board (SAB), and interacts as needed with Key Opinion Leaders (KOL), Primary Investigators and Site Investigators to support clinical and product strategies.
  • Review statistical output from BSC medical device clinical trials and registries and determines appropriate evaluation, interpretation, and presentation of data.

 

What we're looking for in you:

Minimum Qualifications:

  • Education: Bachelors and Masters Degrees in science or engineering required. 
  • Professional Experience: 3 - 5 years of relevant industry experience
  • Clinical trial experience with study design
  • Experience analyzing complex data and presenting it to varying levels of audience

Preferred Qualifications:

  • Education: PhD in science or engineering 
  • Professional Experience: 5 -8 years experience (including Post Doc)
  • Medical device experience

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 435634

 


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