• Job Description

  Req#: 574551

  Additional Location(s): US-AL-Mobile/Dothan; US-AL-Anniston; US-AL-Auburn; US-AL-Birmingham; US-AL-Montgomery; US-AL-Northern/Huntsville; US-AL-Tuscaloosa; US-AR-Eastern; US-AR-Fayetteville; US-AR-Fort Smith; US-AR-Little Rock; US-AZ-Flagstaff; US-AZ-Lake Havasu; US-AZ-Phoenix; US-AZ-Tucson; US-AZ-Yuma; US-CA-Valencia; US-DC-Washington; US-DE-Delaware; US-FL-Daytona; US-FL-Ft. Lauderdale; US-FL-Ft. Myers/Naples; US-FL-Gainesville/Ocala; US-FL-Jacksonville; US-FL-Melbourne; US-FL-Miami; US-FL-Orlando; US-FL-Pensacola/Panama City; US-FL-St. Petersburg; US-FL-Tallahassee; US-FL-Tampa; US-FL-West Palm Beach; US-GA-Alpharetta; US-GA-Atlanta; US-GA-Central/Augusta; US-GA-Macon; US-GA-Savannah; US-GA-Southwest; US-IA-Cedar Rapids; US-IA-Davenport; US-IA-Western/Sioux City; US-ID-Boise; US-ID-Idaho Falls/Pocatello; US-ID-Northern; US-ID-Twin Falls; US-IL-Bloomington/Peoria; US-IL-Chicago; US-IL-Quincy; US-IL-Springfield/Champaign; US-IN-Bloomington; US-IN-Evansville; US-IN-Fort Wayne; US-IN-Gary/Merrillville; US-IN-Indianapolis; US-IN-Lafayette; US-IN-Terre Haute; US-KS-Kansas City; US-KS-Overland Park; US-KS-Topeka/Manhattan; US-KS-Wichita Western; US-KY-Bowling Green/Paducah; US-KY-Lexington; US-KY-Louisville; US-LA-Alexandria; US-LA-Baton Rouge; US-LA-Lafayette/Lake Charles; US-LA-New Orleans; US-LA-Northern; US-LA-Shreveport; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Marlborough; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MD-Baltimore; US-MD-Columbia; US-MD-Hunt Valley; US-MD-Montgomery County; US-MD-Rockville; US-MD-Salisbury; US-ME-Northern/Bangor; US-ME-Southern/Portland; US-MI-Ann Arbor; US-MI-Detroit; US-MI-Flint/Saginaw; US-MI-Grand Rapids; US-MI-Kalamazoo; US-MI-Lansing; US-MI-Northern; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Plymouth; US-MO-Jefferson City; US-MO-Kansas City/Independence; US-MO-Northeastern; US-MO-Quincy; US-MO-Southeastern; US-MO-Springfield/Joplin; US-MO-St. Louis; US-MS-Central; US-MS-Northern; US-MS-Southern; US-MT-Eastern/Billings; US-MT-Great Falls; US-MT-Helena/Butte; US-MT-Western/Missoula; US-NC-Charlotte; US-NC-Eastern/Greenville; US-NC-Greensboro; US-NC-Raleigh/Durham; US-NC-Western/Asheville; US-NC-Wilmington/Fayetteville; US-NC-Winston Salem; US-ND-Central; US-ND-Eastern; US-ND-Valley City; US-ND-Western; US-NE-Lincoln; US-NE-Omaha; US-NE-West/North Platte; US-NH-Northern; US-NM-Albuquerque; US-NM-Santa Fe; US-NV-Las Vegas; US-NV-Reno; US-OH-Akron; US-OH-Cincinnati; US-OH-Cleveland; US-OH-Columbus/Zanesville; US-OH-Dayton; US-OH-Northwest; US-OH-Toledo; US-OH-Youngstown; US-OK-Central-Oklahoma City; US-OK-Eastern/Tulsa; US-OR-Central; US-OR-Portland; US-OR-Salem; US-OR-Southern; US-PA-Allentown; US-PA-Altoona; US-PA-Erie; US-PA-Harrisburg; US-PA-Philadelphia; US-PA-Pittsburgh; US-PA-State College; US-PA-Wilkes Barre; US-PA-York/Lancaster; US-RI-Coventry; US-RI-Providence; US-SC-Columbia; US-SC-Florence/Myrtle Beach; US-SC-Greenville/Spartanburg; US-SC-South/Charleston; US-SD-East/Sioux Falls; US-SD-West/Rapid City; US-TN-Chattanooga; US-TN-Jackson; US-TN-Knoxville; US-TN-Memphis; US-TN-Nashville; US-TX-Abilene/Odessa; US-TX-Amarillo/Lubbock; US-TX-Austin; US-TX-Dallas; US-TX-East/Tyler/Beaumont; US-TX-El Paso; US-TX-Fort Worth; US-TX-Houston; US-TX-San Antonio; US-TX-South/Corpus Christi; US-TX-Waco; US-TX-Wichita Falls; US-UT-Provo; US-UT-Salt Lake City; US-VA-Alexandria; US-VA-Charlottesville/Harrisonburg; US-VA-Fairfax; US-VA-McLean/Arlington; US-VA-Norfolk/Hampton Roads; US-VA-Northern; US-VA-Richmond; US-VA-Roanoke; US-VA-Vienna; US-VT-Northern; US-VT-Southern; US-WA-Bellevue/Redmond; US-WA-Central/Yakima; US-WA-Eastern/Spokane; US-WA-Seattle; US-WA-Tacoma/Olympia; US-WI-Eau Claire/LaCrosse; US-WI-Green Bay/Appleton; US-WI-Madison; US-WI-Milwaukee; US-WI-Northern; US-WV-Northern; US-WV-Southern; US-WY-Casper; US-WY-Cheyenne

  Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

  At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

  
  About the role:

  The Fellow, Clinical Scientist provides CRV 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. They will provide strategic direction for clinical trial and non-clinical trial options and leads strategic decisions related to clinical evidence to support product development. This role 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:

  • Encourages innovation and boundary breaking in the development of clinical trial and non-clinical trial strategic direction within CRV scientific, therapeutic areas (inclusive of competitive landscape) and medical device expertise.
  • Expert knowledge in one or more area and technical lead on major projects regarding clinical input for new product development, post-market surveillance, recertification, business development and may support due diligence assessments.
  • Authors and/or is consulted on 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 claim support.
  • Clinical Subject Matter Expert for Product Development Teams in the evaluation of Product Risk and Design Control Process. Expert knowledge of Clinical accuracy of harms in Hazard Analysis, product FMEA and DFU/IFU.
  • Authors Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms, and support of safety and performance for product approval.
  • Expert knowledge of linkage between clinical harms identified in Clinical Evaluations and Risk Analysis throughout the product lifecycle.
  • Expert knowledge of statistical output from BSC medical device clinical trials and registries and determines appropriate evaluation, interpretation, and presentation of data.
  • Established network of strong relationships with internal and external scientific, technical, and organizational leaders to support clinical and product strategies including study and site clinicians and investigators.
  • Authors and/or is consulted on presentations 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.
  • Stay abreast of current clinical practice competitive landscape and independently conducts scientific literature searches on medical devices (product/product families)/therapeutic areas, analyzes scientific data, and attends scientific congresses.
  • Proactively shares information with peers, management, senior management and technical leadership (e.g., teach backs, regulatory, technical services, marketing, etc.)

  
  Required qualifications:

  • Bachelor's degree in sciences required
  • Minimum 10 years industry experience preferably within the Medical device industry
  • Good understanding of regulatory guidelines and good clinical practices
  • Excellent analytical, verbal, written and presentation skills
  • Proven success creating and maintaining relationships with HCPs

  
  Preferred qualifications:

  • Advanced degree in the Life Sciences, engineering or equivalent required, PhD or equivalent preferred
  • Proven success within the Medical Affairs and/or Marketing functions including implementation of medical strategic plans and medical education initiatives
  • Therapeutic area experience within electrophysiology is preferred
  • Knowledge and understanding of global healthcare standards
  • Strong medical/scientific writing skills

  Requisition ID: 574551

  Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

  
  As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

  So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

  At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

  Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

  Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

  RSRBSC

• About the company

  Boston Scientific is primarily known for the development of the Taxus Stent, a drug-eluting stent which is used to open clogged arteries.

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