Senior Director, R&D IT

Mylan Inc.

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here’s how the role will make an impact:

 

Key responsibilities for this role include:

• Develop and own the global R&D IT strategy and 3–5-year roadmap across Clinical, Regulatory, Medical Affairs, Safety/PV, Biostatistics/Statistical Programming, and R&D data and analytics.
• Partner with R&D leaders to translate business strategy, pipeline priorities and process needs into technology capabilities, investment priorities and measurable outcomes.
• Provide strategic ownership and governance for the R&D application portfolio, including Veeva Clinical (eTMF, CTMS, Study Startup), Veeva RIM/Regulatory, Medical Affairs and Oracle Pharmacovigilance/Product Safety platforms.
• Own the strategy and lifecycle of validated Statistical Computing Environments supporting Biostatistics and Statistical Programming, including SAS and R/Python ecosystems, secure clinical data access, reproducible analysis and regulatory submission support.
• Drive an integrated R&D architecture and data strategy that improves interoperability, reduces technical debt and enables trusted analytics, automation and responsible AI across R&D.
• Ensure R&D systems comply with applicable GxP requirements, 21 CFR Part 11, EU Annex 11, data integrity, privacy and cybersecurity.
• Lead global R&D technology programs and application lifecycle management from business case and design through validation, deployment, adoption, operations and retirement.
• Own the R&D IT portfolio and budget, optimizing investment, total cost of ownership, licensing, vendor spend and delivery capacity.
• Manage strategic technology partners, including Veeva, Oracle and other key R&D platform/service providers, and establish KPIs for service performance, compliance, adoption and business value.
• Build and lead a high-performing global R&D IT organization across business partnering, product/platform ownership, architecture, delivery and application operations.
• Provide executive communication and governance for R&D technology strategy, priorities, investments, risks, architecture decisions and business outcomes.
• Executive partnership with R&D leadership, Office of CIO and governance bodies for strategy alignment, portfolio prioritization, project approvals and funding.
• Executive partnership with R&D functional leaders for demand management, roadmap governance, value realization and service performance.

 

The minimum qualifications for this role are:

• Bachelor’s degree required; with a specialization in Business Administration, Engineering or Computer Science preferred.  
• 15+ years of Progressive leadership experience in pharmaceutical/biotechnology R&D technology or information systems required.
• 10 years of experience in leadership of global R&D IT portfolios and complex regulated technology programs.
• 8 years of experience across Clinical and Regulatory technology, including Veeva Clinical and/or Veeva RIM and with GxP computerized systems, validation and regulated application lifecycle management.
• 5 years of experience supporting Biostatistics/Statistical Programming and validated Statistical Computing Environments.
• 5 years of experience with Medical Affairs, Safety/PV, R&D data, analytics, automation and/or AI capabilities.
• Broad understanding of the pharmaceutical R&D lifecycle, including Clinical Development, Regulatory Affairs, Medical Affairs, Pharmacovigilance/Product Safety and Biostatistics/Statistical Programming.
• Strong experience of Pharmacovigilance and Adverse Event reporting systems and processes.
• Strong experience with R&D platforms, particularly Veeva Clinical and Veeva RIM/Regulatory, and their integration with adjacent R&D systems and data platforms.
• Strong knowledge of validated Statistical Computing Environments and technologies supporting Biostatistics and Statistical Programming.
• Demonstrated experience leading global R&D IT portfolios, large transformation programs, platform lifecycle management and strategic vendors in a regulated environment.
• Experience with R&D data, analytics, automation and responsible AI capabilities is preferred.
• Strong executive communication, stakeholder management, people leadership and ability to operate effectively in a global matrixed organization.
• Experience and comfort in working in a dynamic fast paced environment.
• Role offers hybrid working arrangement with preference for candidates on US East Coast.

Exact compensation may vary based on skills, experience, and location.  The salary range for this position is $151,000 - $314,000 USD.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

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