Sr Clinical Scientist Job

Date: Feb 6, 2018
Location: Valencia, CA, US, 91355
Company: Boston Scientific
Additional Locations: (n/a); US-CA-Los Angeles
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.
Why join Boston Scientific Neuromodulation in California?
We integrate all global operations at our worldwide headquarters in Valencia, California, close to Los Angeles, close to the beach, close to the mountains, close to the desert. All the advantages of Southern California and more affordable than many other areas nearby. Looking for onsite amenities? Check out our on-campus Bistro, Credit Union, private gym, and Toastmasters club. Take advantage of the 360 days of sunshine a year on our basketball and volleyball courts. Join our softball and soccer teams. We even have cricket and dragon boat racing teams! We also offer numerous volunteer activities and events in the wonderful communities of Valencia and Santa Clarita. If you like to work hard and play hard, you'll fit right in. And you'll be well rewarded. Our salaries are competitive. Our benefits package is generous. And our 401K program? Forbes ranks it one of the top 10 in the country!
About This Role:
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, 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 Include:
Provides clinical trial and non-clinical trial strategic direction within Neuromodulation scientific, 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:
Basic Qualifications
Education: Bachelors and Masters Degrees in science or engineering required.
Professional Experience: 5 years of relevant industry experience.
Management Experience: 1 year coaching or mentoring.
Preferred Qualifications
Education: PhD in science or engineering
Professional Experience: 8 years experience (including Post Doc)
Management Experience: 2 years of coaching or mentoring
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
Requisition ID: 354253
Nearest Major Market: Los Angeles
Job Segment: Scientific, Neurology, Clinic, Medical, Engineer, Engineering, Healthcare

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