Director, R&D Core Enablement

The Director builds digital, data, and AI capabilities that help R&D move faster without compromising rigor, compliance, or quality. R&D Quality retains ownership of quality systems and chemical compliance standards, while the Director provides executive sponsorship and program oversight for laboratory functional maintenance within Core Enablement in partnership with qualified subject-matter experts.

Success is measured by scalable, compliant systems that reduce manual work, improve visibility and decision-making, and shorten development and change-control cycle times.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

The Director partners with R&D leaders, Quality, Regulatory, IT, and Operations to turn business needs into interoperable, compliant digital and AI-enabled solutions that improve efficiency, decision quality, and speed.

Position Responsibilities:

R&D Digital Tools, Systems & AI Enablement

QUALIFICATIONS

The successful candidate will have a record of building and implementing digital systems that materially improve technical operations, including practical applications of AI or advanced analytics in development workflows. Familiarity with EHS, chemical compliance, and regulatory pathways is valued; deeper proficiency may be developed through partnership with R&D Quality and qualified subject-matter experts.

Core competencies: digital and systems leadership, change leadership and adoption, governance and compliance enablement, cross-functional influence, continuous improvement, and business and financial acumen.

• Own the R&D digital enablement roadmap, deploying tools, platforms, templates, dashboards, and AI-enabled solutions that streamline product development, documentation, change control, data analysis, and reporting.
• Identify, prioritize, and scale high-value AI and advanced analytics use cases that shorten development timelines, strengthen technical decisions and risk identification, and reduce manual effort.
• Embed intuitive, scalable tools in standard R&D workflows and serve as R&D’s primary partner to IT and external vendors for development and optimization.

Quality Systems & Digital Compliance

• Embed applicable quality, regulatory, and data-governance requirements into R&D digital systems, with the documentation, controls, and traceability needed for audit and inspection readiness.
• Provide executive sponsorship and program-level oversight for laboratory EHS and chemical compliance programs, including chemical hygiene, hazardous waste management, and shipping activities executed by trained and qualified site personnel.

Change Control & Governance Enablement

• Establish and sustain digitally enabled change-control governance, standards, and approval workflows that support clear, traceable, and consistent decisions.

Documentation, Templates & Knowledge Management

• Own R&D documentation standards, templates, and digital knowledge repositories to improve quality and speed while making institutional knowledge accessible and reusable across programs.

Training, Adoption & Capability Building

• Build digital fluency and data-driven decision-making through practical training and change management that convert technical deployments into sustained productivity gains.

Performance Enablement & Continuous Improvement

• Partner with the Project & Performance Office to provide real-time visibility into KPIs, capacity, and execution health, using insights and user feedback to remove bottlenecks and continuously improve systems and tools.

LEADERSHIP & COLLABORATION RESPONSIBILITIES

• This R&D-wide role succeeds through influence. The Director builds cross-functional partnerships, uses data to align stakeholders and drive adoption, brings systems thinking and business judgment to ambiguity, and balances speed, rigor, quality, and compliance when setting priorities and making decisions.

PERFORMANCE MEASUREMENTS

• Performance is measured by adoption and sustained use of R&D digital and AI-enabled tools; gains in cycle time, productivity, decision quality, and risk visibility; audit and inspection readiness; user satisfaction; and the capability and effectiveness of the Core Enablement team.

EDUCATION/CERTIFICATION:

• Minimum MS degree in Engineering, Chemistry, Data Science, Computer Science, Quality Systems, or a related scientific or technical discipline required.
• Advanced degree (PhD, MBA, or equivalent) preferred, particularly with demonstrated application in regulated R&D or product development environments.
• RCRA hazardous waste management training commensurate with management-level oversight responsibilities required; may be completed within the first six (6) months of hire.

REQUIRED KNOWLEDGE:

• End-to-end new product development and lifecycle management in regulated industries, including change-control governance and documentation standards.
• Digital systems and platforms that support product development, data management, and execution governance, including automation, analytics, and AI-enabled tools that improve efficiency, decision quality, and cycle time.
• Cross-functional integration of R&D with Quality, Regulatory, Operations, IT, and Commercial partners.
• Quality-system practices, including change management (MOC), CAPA, nonconformance investigation and management, document control across electronic and paper systems, and periodic review.

EXPERIENCE REQUIRED:

• 10+ years in R&D, quality systems, digital enablement, or operational excellence, including 5+ years of leadership in complex, regulated product development organizations.
• Demonstrated success enabling product development and commercialization through systems, governance, and digital infrastructure; leading R&D initiatives that improve efficiency, scalability, and compliance; and driving adoption of digital and AI-enabled solutions with senior leaders and cross-functional teams.
• Hands-on experience in a regulated quality system, including change management (MOC), CAPA, nonconformance investigations, document control, and periodic review.
• Leadership accountability for laboratory EHS and chemical compliance programs, including oversight of hazardous waste and chemical hygiene activities performed by trained site personnel.

SKILLS/ABILITIES:

• Strong stakeholder and program management skills, with the ability to influence, align, and lead across R&D and cross-functional teams without direct authority.
• Sound understanding of Infection Prevention, Interventional Care, and regulated product development, including how global regulatory and quality standards (FDA, EPA, ISO, and Notified Body requirements) shape R&D systems and documentation.
• Ability to partner with IT, Quality, and external vendors to translate complex technical, regulatory, and business requirements into compliant, scalable digital solutions.
• Ability to communicate complex technical concepts, digital strategies, and performance insights to technical and non-technical audiences while building digital fluency and adoption across R&D.
• Preferred knowledge, to be developed within the first year if needed:
• Working knowledge of the OSHA laboratory standard (29 CFR 1910.1450), RCRA hazardous waste management, New Jersey requirements administered by NJDEP, and DOT hazardous materials transportation sufficient to oversee shipping and waste operations.
• Understanding of FDA and EPA regulatory frameworks relevant to the Core Enablement portfolio, with awareness of Health Canada requirements

WORKING CONDITIONS

• Primarily office-based, with periodic work in laboratory and warehouse areas where chemicals and hazardous waste are handled; site chemical-hygiene and PPE requirements apply.

SALARY RANGE:

$190k-$210k

Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored visa sponsorship.

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

• Health Savings Account (HSA)
• Vision
• 401(k) savings plan with company match and profit sharing
• Basic and supplemental Life and AD&D insurance
• Flexible Spending Accounts (FSAs)
• Short & long-term disability
• Employee Assistance Program (EAP)
• Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.

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