Your responsibilities will include:
- Encourages innovation and boundary breaking in the development of clinical trial strategic direction within clinical scientific, therapeutic areas (inclusive of competitive landscape) and medical device expertise. Recognized as a subject matter expert in clinical organization, clinical trial team and cross-functionally.
- Authors and/or is consulted on clinical trial protocols/designs (pre-market and post-market) and regulatory reports (e.g. Clinical Study Reports, Annual Reports, Clinical Summaries) in support of mandated regulatory requirements, product approval and indication expansion.
- Clinical Subject Matter Expert for Product Development Teams, acting as clinical core team representative for NPD (New Product Development) and/or PDP (Product Development Process).
- Knowledge of statistical output and clinical data analysis from BSC and competitors’ medical device clinical trials and registries and determines appropriate evaluation, interpretation, and presentation of data.
- Collaborates with clinicians and medical writers on planning and development of white papers, manuscripts and abstracts for submission and publication in peer reviewed scientific journals. Collaborates with clinicians and medical on planning and development of slide presentations, and poster presentations for scientific meetings/congresses worldwide.
- Established network of strong relationships with internal and external scientific, medical and technical experts 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, Study Investigators/Steering Committee Meetings, Medical Advisory Board (MAB), and interacts as needed with Key Opinion Leaders (KOL), Primary Investigators and Site Investigators.
- Stays abreast of current clinical practice and competitive landscape. Keeps abreast of current trends, new technologies, analyzes scientific data, and attends scientific congresses. Proactively shares information with peers, management, senior management and cross-functional leadership.
Required qualifications:
- Interventional cardiologist with MD/DO degree (or accepted international equivalent).
- Minimum 10 years of clinical trial experience, structural heart and/or interventional cardiology preferred.
- Effectively communicates 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.
- Proven knowledge of the regulations and standard practices governing clinical research.
- Proven knowledge of clinical statistical principles.
Preferred qualifications:
- Advanced degree, (For example - PhD.) preferred, in medical or biological sciences or field associated with clinical research.
- Experience in medical device industry preferred.
The anticipated annualized base amount or range for this full time position will be$ to $, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.
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.
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 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.