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Senior Clinical Scientist Job

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Date: Jun 11, 2021

Location: Valencia, CA, US, 91355

Company: Boston Scientific

Additional Locations: US-CA-Los Angeles

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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.

 

***This position is based in the U.S. but City/State is flexible. 


About the role:
The Senior Clinical Scientist is responsible for leading the strategy, planning, design, development, execution, and implementation of clinical research projects. This is a highly technical professional role that will be focused on leading cross-functional teams supporting early stage clinical studies and development of next generation neuromodulation products.  This person will work very closely with R&D to assess the feasibility of medical devices by developing strategies for clinical trial design, evaluation of clinical safety and performance/efficacy, regulatory submissions, and publications. They will also collaborate with other various internal (Clinical Project Management, Regulatory, Clinical Communication, Clinical Medical Director, 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.  This person may visit various clinical study sites in/around a specific region, primarily, but may travel throughout U.S. and/or internationally on occasion. The Scientist may be in direct patient contact mostly in clinical settings, including hospitals, surgical centers, physician clinics, assuming the risks therein (e.g. proximity to biohazardous materials, infectious disease, radiation, etc.).  There will be up to 50% travel on episodic basis.   

 

Key responsibilities include:

  • Oversees project teams to plan, execute, and manage clinical research studies evaluating  the feasibility of business critical projects.
  • Oversees clinical studies and/or programs in accordance with strategy, milestones, project plans/deliverables, approved budget and resource allocations following applicable regulatory and standard operating procedures.
  • 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.
  • In collaboration with the project team and external clinical sites, lead clinical study execution (e.g. product and protocol training, protocol execution, patient recruitment, device management, patient education, implant and trial procedures, device programming, device troubleshooting, regulatory compliance, complaint reporting and data management).
  • Occasional case coverage or technical support assistance for patient device trial and implant procedures, including in the Operating Room environment
  • Complex or advanced device programming to provide therapy to patients
  • Supports technical team through product development activities, taking devices from exploratory concepts to human use; including market & functional specifications, risk management, verification/validation testing and documentation. 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. 
  • Maintains substantial knowledge of state-of-the-art neuromodulation principles and theories to serve as a subject matter expert within the division and present study progress to Management as needed.
  • Maintains composure in complex, stressful situations and able to think critically under pressure to effectively solve complex technical problems.
  • Effectively communicate and tailor complex messages including technical concepts, clinical data to people of varied backgrounds, experience and technical abilities (e.g. patient education, peer-to-peer training, investigator training, scientific literature, etc.). 
  • 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.
  • 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.
  • .Serve as Clinical representative on project teams; Build and maintain strong relationships with internal scientific, technical, and organizational leaders to support Regulatory, Clinical, and product strategies and associated risks; clearly communicate pertinent project/function information.


What we’re looking for in you: 
Minimum Qualifications

  • Degree in science, mathematics, or engineering:
    • BS with 6+ yrs relevant experience
    • MS with 4+ yrs relevant experience
    • PhD with 2+ yrs relevant experience
  • Clinical research experience required with medical devices ? 

Preferred Qualifications

  • Degree in biomedical engineering, electrical engineering, computer science, applied mathematics, neuroscience or related field 
  • Advanced degree preferred
  • Knowledge of neuromodulation therapeutic area
  • Experience with direct patient contact and managing relationships with physicians in a clinical or hospital environment
  • Project management experience, managing scope while maintaining budget and timelines

 

 

Requisition ID: 483439

 

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 drug-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.

 


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