Director, Product Risk and PMCF

Additional Locations: 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 Product Risk and PMCF Director who will provide strategic, process and people leadership for the Urology Clinical Product Risk and Post Market Clinical Strategy organization.  In this role you will have the opportunity to oversee strategy and execution of clinical evidence report writing and post market clinical plans and follow-up reports as well as provide innovative solutions and lead resolution of organizational issues and process improvement efforts through analysis and cross-functional collaboration. 

The Director acts as a functional subject matter expert and represents their function to internal cross-functional partners and external stakeholders, while also leading, developing, and supporting a team of Product Risk and Post Market Clinical Strategy Managers. The Director, Clinical Product Risk reports directly to the Urology Chief Medical Officer.

Your responsibilities will include:

• Lead the development of Clinical Risk and Post Market Clinical evidence strategy. Collaborate with cross-functional partners to align and execute strategic roadmaps.  
• Lead, in conjunction with product risk and Post Market Clinical strategy managers, all aspects of clinical evidence curation and risk management research, analysis, interpretation and document generation.  Identify risks and issues. Develop and communicate proposed solutions to teams and senior management as required.
• Coordinate and lead efforts to develop and maintain Clinical Risk and post-market clinical follow up documentation, reports, and data sets.  Ensure adherence to internal quality standards, external regulations, and reporting cadence.
• Provide clinical strategy leadership and scientific expertise throughout product development and implementation of local or global Regulatory requirements.  Provide leadership for the overall Clinical Sciences organization in EUMDR clinical evidence requirements, guidance interpretation and evidence generation activity.
• Provide leadership and development for franchise product risk and Post Market clinical strategy managers.  Drive alignment and collaboration across management team to ensure consistent execution and interpretation, joint innovation, and group problem-solving
• Interact with various study support groups as needed to assist in clinical strategy, the development of study plans, and project deliverables. Interacts with regulatory agencies as needed.
• Facilitate Clinical Risk communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, and other key stakeholders.  Present to leadership forums needed. 
• Manage Clinical Risk timelines required by global Regulatory Bodies by utilizing the appropriate project management tools.
• Participate and on occasion lead discussions regarding end of life product decisions
• Facilitate regulatory submissions and communications by partnering with Regulatory Affairs during the submission process.
• Develop expertise and train others in evolving requirements of international regulations, including but not limited to requirements laid out in MEDDEV and EU MDR.
• Identify functional area specific program risks.  Develop and execute contingency and mitigation plans for programs.  Work with contractors and/or vendors to complete work as necessary and ensure compliance to training, corporate standards, and regulatory agencies.
• Make decisions and clearly communicate pertinent project/function information.  Determines clinical and cross-functional resources and expense requirements for team.  Collaborate with functional managers on quarterly budget issues.
• Collaborate with Clinical and R&D to develop common Clinical deliverable criteria and strategize justification for no clinical trial or aid in development of clinical trial rationalization plan.  Negotiate resource utilization to ensure deliverables are met within timeline and budget.
• Identify, propose and lead process improvements within function.  Develop best practice guidelines to support company or US/OUS regulatory standards and contribute to development of functional SOPs and WIs.  Influence company standards development by participating as a Clinical subject matter expert for Quality initiatives.
• Serve as subject matter expert and Function representative in internal and external audits including audit participation, back-room subject matter expert, preparing audit responses and supporting process improvements resulting from the audit.
• Occasional domestic and international travel for meetings (less than 10%).

Required qualifications:

• Bachelor’s degree in science-related field
• 10+ years of work experience in related field, including EUMDR leadership experience
• 5+ years of people leadership/management experience
• Proven ability to work collaboratively and influence a broad range of global stakeholders
• Demonstrated strategic perspective and ability to align activities with business vision and purpose
• Budget management experience
• Excellent communication and interpersonal skills

 Preferred qualifications:

• 5+ Medical/technical/scientific writing experience
• Advanced degree (Master’s degree and above) in related area
• Relevant product and/or therapeutic knowledge/experience
• Experience working with product development teams (e.g., Medical, Clinical, R&D, Regulatory, Design Quality Assurance)
• Experience interacting with Regulatory Authorities or Notified Bodies
   

Requisition ID: 560089

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!