Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills; US-MN-Mankato/Rochester; 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.
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About the role:
Responsible for shaping and influencing the advancement of medical therapies across all areas of the Interventional Oncology Franchise within Peripheral Interventions Division by rigorously and creatively applying scientific and medical expertise to ensure patient safety, respond to product concerns and ensure compliance with all aspects of the lifecycle of interventional oncology products.
Your responsibilities will include:
Provides medical and scientific guidance to internal and external customers including clinical project teams, other functional units, study investigators and regulatory agencies.
Provides operational support and oversight to teams regarding clinical trial planning, protocol development, investigator selection, training of internal and external personnel, medical monitoring for patient safety and trial conduct, individual and aggregate clinical study event review and approval, data analysis and interpretation, quality control.
Responsible for providing the therapeutic area expertise in interventional oncology throughout the device life cycle, including medical input to risk assessment and processes, product complaints, MDR reports, performance of medical health hazard assessment as part of the evaluation of potential product issues and reportability decisions, and serves as a medical advisor to regulatory teams.
Contributes to application of new technologies to solve complex medical problems, including medical input and clinical due diligence to new product development and business development teams.
Writes/edits clinical and scientific reports and reviews and approves educational and reporting materials. Also reviews and edits clinical trial protocols to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency with BSC Quality Policies.
Develops policies for interaction with independent committees such as clinical event committees or patient safety advisory board; ensures exchange of information with these committees is adequate to meet timelines and objectives.
Responsible for determining the escalation of safety issues for communication and action to senior leadership; interacts with senior management concerning significant safety matters.
May provide trending and safety signal detection and management assessment for the product\'s lifecycle.
Required qualifications:
Minimum of 5 years of clinical experience in the practice OR 7 years of combined clinical/industry work experience within a life sciences company and clinical environment.
MD/DO degree (or accepted international equivalent).
Expert knowledge of and experience in Medical Oncology and interventional management of Interventional Oncology.
Demonstrated leadership experience and strong interpersonal skills with experience working effectively in a team/matrix environment.
Strong analytical skills and attention to detail.
Excellent communication skills (written and verbal).
Ability to convey complex medical concepts to a wide audience both internal and external to the company, across multiple levels of seniority, through formal and informal presentations and written reports.
General, working knowledge of the regulations and standard practices governing clinical research.
General, working knowledge of clinical statistical principles.
The candidate must hold a valid, unrestricted and unchallenged license to practice medicine, and be in good standing with the licensing body.
Preferred qualifications:
Past experience within a medical device company in one of the following functions: medical safety, medical affairs, clinical, R&D, quality, or regulatory.
Prior experience as a clinical investigator in a medical device clinical research study.
Experience applying principles of risk management.
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Requisition ID: 554515
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 \xc2\xa7 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.
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