Principal Clinical Scientist

Additional Location(s): US-CA-Valencia; 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-MN-Arden Hills; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka

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 Principal Clinical Scientist will be responsible for authoring clinical evaluation reports (CERs) and reviewing key clinical risk documents (such as Hazard Analyses and Instructions for Use [IFUs]). This position requires a deep understanding of clinical data, regulatory standards, and risk management requirements. The ideal candidate will possess a keen eye for detail, strong analytical skills, and the ability to work collaboratively with cross functional teams to ensure compliance with regulatory requirements and high standards of patient safety.

Boston Scientific will not offer sponsorship or take sponsorship of an employment visa at this time.

This is a hybrid position (in office minimum three days per week) with the flexibility to be in Valencia, CA or Arden Hills or Maple Grove, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities will include:

• Draft clinical trial protocols for phase III-IV studies, ensuring they are aligned with business objectives and compliant with regulatory standards.
• Develop case report forms (CRFs) posters, manuscripts, and to present study findings to internal teams regulatory bodies, and scientific communities
• Perform data analysis of clinical trial results to assess efficacy and safety outcomes
• Create and oversee the use of case report forms (CRFs) in clinical trials to ensure accurate and consistent data collection
• Analyze and interpret clinical data to assess the safety and performance of medical devices
• Develop and author comprehensive Clinical Evaluation Reports (CERs) in compliance with regulatory standards (e.g., MDR)
• Ensure CERs are up-to-date, accurate, and aligned with clinical evidence requirements for regulatory submissions.
• Perform periodic updates of CERs, Clinical Evaluation Plans (CEPs), and Post Market Clinical Follow-up (PMCF) Plans.
• Draft well-reasoned clinical responses to inquiries from notified bodies during regulatory reviews.
• Collaborate with regulatory affairs, quality assurance, and product development teams to ensure timely and accurate responses.
• Review and contribute to clinical risk documents, such as Hazard Analyses and Risk Management Reports (RMRs).
• Maintain a strong understanding of relevant regulations and standards (e.g., MDR, FDA) to ensure compliance.
• Work closely with cross-functional teams to support regulatory submissions and align clinical and risk management documentation.
• Contribute to clinical and cross-functional process improvements and maintain knowledge of relevant work instructions and standard operating procedures.

Required qualifications:

• Minimum Masters or PhD degree in a relevant field (i.e., Life Sciences, Biomedical engineering) with 7 years of related work experience
• Minimum 5 years' experience in authoring Clinical Evaluation Reports (CERs), drafting clinical responses to notified bodies, and working with clinical risk management documentation
• Strong analytical and problem-solving skills, with the ability to interpret complex clinical data

Preferred qualifications:

• Preferred experience with neuromodulation and interventional spine therapies

Requisition ID: 597393

Minimum Salary: $100700

Maximum Salary: $191300

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.

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