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Director of RWE

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Marlborough, MA / Bedford, MA, US.

Boston Scientific is seeking a visionary and dynamic Director to establish and lead a Corporate Advisory Function focused on Real-World Evidence (RWE) projects. This role will be pivotal in shaping our strategy for leveraging real-world data to drive innovation, improve patient outcomes, and support regulatory and market access initiatives. The Director will work cross-functionally to ensure the integration of RWE insights into the company’s strategic decision-making processes and evidence-generation strategies and plans. The incumbent will travel domestically for up to 10% which includes conferences, meetings, etc.

Your responsibilities will include:

⦁    Strategic Leadership – Develop and implement a comprehensive RWE strategy aligned with Boston Scientific’s evidence generation strategies and plans aligned with business goals for the next three to five years.
⦁    Establish the Corporate Advisory Function as a center of excellence for RWE, providing expert consultation and support across the organization.
⦁    Collaborate with senior leadership to identify opportunities for RWE projects that align with corporate objectives.
⦁     Project Management – Assist with the design, execution, and analysis of RWE projects, ensuring they meet scientific, regulatory, and business requirements.
⦁    Coordinate cross-functional teams, including sourcing, clinical/medical, R&D, regulatory, market access, and commercial, to ensure seamless project execution.
⦁     Develop and maintain timelines, budgets, and resource plans for RWE initiatives.
⦁     Stakeholder Engagement -Serve as the primary point of contact for internal and external stakeholders on RWE-related matters.
⦁     Assist in fostering strong relationships with key opinion leaders, academic institutions, healthcare providers, and regulatory agencies as well as important internal stakeholders.
⦁     Present RWE findings and insights to senior leadership, regulatory bodies, and other stakeholders.
⦁     Data Integration and Analysis–  Assist with the collection, integration, and analysis of real-world data from diverse sources, including electronic health records, claims data, and patient registries.
⦁     Ensure the application of robust epidemiological and biostatistical methods to generate high-quality evidence.
⦁    Stay updated of advancements in data science, analytics, and RWE methodologies to continuously enhance the function’s capabilities.
⦁    Compliance and Quality – Ensure all RWE activities comply with relevant regulatory requirements, ethical standards, and Boston Scientific’s policies.
⦁    Implement quality assurance processes to maintain the integrity and reliability of RWE data and analyses.

Required qualifications:
⦁    Minimum Master’s degree or advanced degree (PhD, MD, or equivalent) in Epidemiology, Biostatistics, Health Economics, Public Health, Bioinformatics, or a related field.
⦁    Minimum of 10 years of experience in the healthcare, pharmaceutical/life sciences, or medical device industry, with a focus on real-world evidence, health economics, or outcomes research.
⦁    Proven expertise in epidemiological methods, biostatistics, and data analytics.
⦁    Strong experience with big data platforms and tools such as Hadoop, Spark, R, Python, or similar.
⦁    Strong knowledge of regulatory requirements and guidelines related to RWE.
⦁    Proven track record of participating in and leading RWE projects and teams, with experience in designing and executing studies that support regulatory and market access decisions.

Preferred qualifications:

⦁    In-depth knowledge of global regulatory requirements and guidelines for RWE, including FDA, EMA, and other relevant bodies.
⦁    Proven experience in preparing regulatory submissions and interacting with regulatory agencies.
⦁    Proficiency in machine learning and artificial intelligence to analyze complex datasets and generate predictive insights.
⦁    Strong leadership and strategic thinking abilities with demonstrated experience
⦁    Excellent project management skills, with the ability to manage multiple projects simultaneously.
⦁     Exceptional communication and interpersonal skills, with the ability to engage and influence stakeholders at all levels.
⦁    Prior or current experience in designing and managing clinical trials, particularly those that incorporate real-world data.

Requisition ID: 588736

Other locations: US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Plymouth.

**This role accommodates hybrid work arrangement (three times a week) at our Marlborough, MA or Maple Grove, MN locations. **

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.

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 is proud to be an equal opportunity and affirmative action employer.

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.

This job is posted by Boston Scientific.

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