VP, Clinical Trials - SHV & ICTx

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 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 innovative work environment. 
  • Commitment to fostering professional growth and creating a supportive work environment that will empower individuals to reach their fullest potential.
  • Set clear performance expectations and goals for team members. Track and evaluate performance, recognize achievements, and address challenges to drive continuous improvement.
• Culture:
  • Foster a culture of scientific excellence, continuous learning, and appropriate risk-taking within the team.
  • Ensure that Clinical Sciences excels in the areas of strategic thinking, accountability to business needs and goals, and acting as collaborative partners will all stakeholders and customers.
  • Provide leadership and advocacy for organizational change strategies, including structural, cultural, and strategic change.
  • Act as a change agent across areas of responsibility to drive the evolution of the Clinical Science organization forward and ensure change readiness and capability of organizations under leadership.
  • Identify and drive continuous improvement activities across Clinical Science, and works to instill a culture of continuous improvement, transparency and problem-solving across the organization.
• Cross-functional Collaboration:
  • Collaborating with internal teams, including R&D, Regulatory, Quality, Marketing, Commercial and Business Development, to integrate clinical insights into overall product development and commercialization strategies.
  • Work closely with Regulatory Affairs leadership to ensure timely and successful submission of clinical trial applications and product registrations, including representing the company in interactions with regulatory authorities to gain approval for clinical trials and product marketing applications.
  • Work closely with external partners, including contract research organizations (CROs), the Company’s Global Commercial Operations group (GCO), academic institutions, and key opinion leaders to facilitate investigator-sponsored and collaborative clinical research efforts.

Required qualifications:

• Advanced degree (Ph.D., MD, or equivalent) in a relevant scientific discipline preferred.
• Minimum 10 years of experience in clinical research and development within the healthcare or pharmaceutical industry, including leadership roles.

Preferred qualifications:

• Proven track record of leading organizations through successful clinical trial design, execution, and regulatory submissions.
• Strong knowledge of clinical trial regulations, GCP guidelines, and relevant healthcare compliance standards.
• Exceptional leadership skills with the ability to inspire and guide cross-functional teams. Demonstrated history of leading Clinical organizations through significant change, including structural, cultural, and strategic change.
• Strategic mindset with the ability to align clinical objectives with business goals.
• Excellent communication and interpersonal skills, capable of representing the company in external settings.
   

Requisition ID: 592792

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 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.