Associate Senior Fellow Clinical Scientist

• Location: Galway
• Req Number: 615581
• Contract Type: Permanent
• Reporting to: Sr Director, Clinical Trials 
• Closing Date: 15th October

IMPORTANT

You are required to inform your Supervisor/Manager of your application within 48 hours of applying. Please ensure that you meet the educational requirements for the role. Failure to do so may impact your application. 

Job Purpose:

The Associate Senior Fellow Clinical Scientist  provides specialized clinical expertise in Interventional Cardiology, in support of strategic clinical trial development. This includes leading the design of clinical protocols, contributing to regulatory submissions, and overseeing the analysis and dissemination of clinical data. Your role involves cross functional collaboration with internal departments and external experts to ensure alignment of clinical evidence strategies with product development goals. Additionally, the incumbent serves as a key liaison to the scientific community and monitors therapeutic aspects of investigational medical devices to uphold clinical integrity and innovation.

Work Mode: This role follows hybrid work mode requiring employees to be in our BSC Marlborough, MA or Maple Grove, MN office at least three days per week.

Key Responsibilities:

• 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.      

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. 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 is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com.

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