VP, Clinical Trials - SHV & ICTx
Boston ScientificAbout the role
Additional Location(s): US-MA-Marlborough
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:
Boston Scientific is seeking a highly experienced and visionary Vice President, Clinical, Structural Heart Valves (SHV) and ICTx Clinical Operations to lead and drive the clinical research for SHV and Clinical Operations efforts of our ICTx Team.
The successful candidate will be responsible for overseeing the design, execution, and interpretation of clinical trials, ensuring the safety, efficacy, and regulatory compliance of our products. This role will play a pivotal role in shaping the SHV’s clinical strategy, working closely with cross-functional teams to advance the safe and efficacious utilization of our product portfolio.
This role will report into the Chief Medical Officer ICTx and will sit on the ICTx leadership team.
Your responsibilities will include:
- Clinical Strategy and Leadership:
- Provide strategic guidance and support to the core functions of the Clinical Sciences team, overseeing franchise Clinical Strategy, Clinical Operations, and Clinical Evidence. Ensure excellence in planning and execution of SHV clinical programs.
- Drive the collaborative development and execution of the SHV clinical development strategy – working in conjunction with the business to deliver in alignment with the company and division’s overall vision and objectives.
- Collaborate with executive leadership to align clinical objectives with the company's business strategy and key internal and external customers and stakeholders.
- Stay abreast of advancements in clinical science, therapeutic trends, and regulatory guidelines – providing medical expertise to the Division on forward-looking product development and clinical strategy. Drive innovation in all clinical science areas, including design, methods, data sources, partnerships, and other clinical engagement.
- Provide clinical input for the upstream development of new products, the continued improvement of existing products, and the assessment of potential acquisitions.
- Partner with the Chief Medical Officer to build and maintain relationships with external KOLs, academic institutions, and professional societies to enhance the organization's scientific credibility and reputation, and to provide meaningful insights into the Urology clinical research strategies.
- Support clinical diligence associated with business development, merger, and acquisition initiatives.
- Clinical Trial Design and Execution:
- Provide strategic guidance on the design and planning of clinical studies, ensuring robust protocols that meet regulatory requirements and generate meaningful data that will support the safe and efficacious adoption of products following launch.
- Provide leadership as needed on the conduct of clinical trials, ensuring compliance with GCP, relevant regulations, and ethical standards.
- Ensure clinical trial progress and effectiveness, resolving escalated challenges and potential risks.
- Drive effective and efficient clinical operations by continually strengthening the organization’s strategic approach to evidence generation (e.g., Trial strategies) and trial execution (e.g., insource vs. outsource considerations).
- Clinical Evidence Evaluation:
- Oversee the development and implementation for Clinical Evaluation Plans, Reports, and Post-Market Clinical Evaluation Plans, and Reports. Collaborate with key stakeholders to identify communication priorities and target audiences.
- Providing clinical perspective and input to cross-functional teams such as risk management, product management, and post-market surveillance.
- People Leadership:
- Attract top talent and build a high-performing team to deliver on Division’s goals and objectives.
- Excel at clear and transparent communication, ensuring that information flows smoothly both top-down and bottom-up within the team. Actively listening to the team's concerns and ideas will be crucial in building a culture of trust and collaboration.
- Actively promote diversity and inclusion within the workplace. Value individual differences and foster an inclusive culture for a richer and more innova
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