Your responsibilities will include:
- Lead and manage clinical trials to ensure efficient execution, scientific accuracy, and timely delivery of results, supporting the integration of RDN therapies into Boston Scientific's operations.
- Partner closely with physicians, Key Opinion Leaders (KOLs), and newly acquired company leaders to incorporate their insights and align with clinical and organizational goals.
- Actively oversee the clinical trial process, from feasibility assessments and trial design to evidence dissemination, ensuring alignment with business objectives.
- Uphold scientific integrity and compliance with ethical and regulatory standards throughout all aspects of clinical trial operations.
- Develop and implement strategic plans for clinical evidence generation that drive the success of RDN therapies and support business growth.
- Direct the design, planning, execution, and reporting of all company-sponsored clinical trials and evidence-generating programs on a global scale.
- Develop operational strategies to optimize clinical trial execution, leveraging internal resources and synergies for maximum efficiency.
- Collaborate with newly acquired company leaders to identify areas where internal resources can be leveraged to ensure the success of RDN therapy integration.
- Actively participate in strategic planning within the organization, translating high-level decisions into actionable clinical operational plans and delivery.
- Provide leadership guidance, direction, and oversight to Contract Resource Organizations (CROs) and external vendors involved in clinical trial programs.
- Establish and maintain strong relationships with clinical trial investigators, KOLs, and other external stakeholders, including assisting in the identification and selection of clinical trial investigators.
- Advise and contribute to the development of global business strategy, providing status updates on the progress of clinical trial programs and their alignment with business goals.
- Build cross-functional collaborations through business units, corporate clinical teams, and geographies to achieve organizational objectives, fostering operational synergies and innovative approaches to clinical evidence generation.
- Provide leadership that promotes motivation and empowerment of others to accomplish individual, team, and organizational objectives.
- Assist in the recruitment, training, and development of the clinical team to ensure the efficient operation of the function and build the infrastructure to support advanced clinical trials.
- Ensure compliance with company policies, procedures, and applicable regulatory requirements.
- Represent the clinical team in discussions with Health Authorities.
- Support the integration of RDN therapies into the organization's operations through domestic and international travel as needed.
Required qualifications:
- Bachelor’s degree and a minimum of 15 years of clinical trial operations, strategy, and management experience in the interventional cardiology or medical device space.
- Minimum 8 years of experience building and leading high-performing teams in cross-functional and collaborative environments.
- Proven expertise in developing and executing operational strategies, with demonstrated success in executing clinical trial programs across various phases of development.
- Proven experience designing, planning, and managing clinical trials or research studies that align with clinical and business objectives.
- Proven budget management skills and the ability to strategically allocate resources effectively.
Preferred qualifications:
- Preferred advanced degree (PhD preferred) in medical or biological sciences, or a field associated with clinical research.
- Proven hands-on experience with First in Human (FIH), early feasibility, or Phase II- IV clinical trials, particularly in device-driven therapies.
Maximum Salary: $ 327800
Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.
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.