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BD

Senior Director, Corporate Preclinical Development and Toxicology

Location
NC (NC)
Posted
Posted today (employer shows the date only)
Source
Workday (employer's applicant tracking system)
Category
R&D/Science
Industry
Medical Device
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We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.





Job Description

Job Responsibilities:

  • Provide strategic, scientific, operational, and organizational leadership for CPDT, aligning capabilities, priorities, investments, and service delivery with BD strategy and portfolio needs.
  • Oversee internal and external programs addressing toxicology, biocompatibility, chemical characterization, and preclinical safety for medical devices and combination products.
  • Serve as Testing Facility Management for applicable Good Laboratory Practice studies and ensure appropriate personnel, facilities, equipment, methods, quality oversight, and corrective actions are in place.
  • Provide executive leadership for the CPDT Quality Management System and maintain compliance with applicable GLP requirements, ISO/IEC 17025, data integrity expectations, and internal quality requirements.
  • Provide clear scientific and operational direction while balancing patient and user safety, regulatory expectations, quality, cost, schedule, and portfolio priorities.
  • Partner with R&D, Regulatory Affairs, Quality, Medical Affairs, business units, and other stakeholders on innovation, product development, regulatory submissions, sustaining engineering, investigations, and post-market needs.
  • Translate complex scientific and regulatory matters into clear options and recommendations for executives and cross-functional teams.
  • Represent BD with regulatory authorities, customers, auditors, industry organizations, standards committees, and external scientific partners.
  • Lead, develop, and retain a diverse organization of scientific, technical, quality, project management, informatics, and business professionals, with a strong focus on succession, capability, engagement, and accountability.
  • Own financial and resource stewardship, including operating and capital budgets, forecasts, capacity planning, external spending, vendor strategy, cost models, and investment trade-offs.
  • Establish portfolio priorities and allocate resources across competing needs using transparent criteria, effective governance, meaningful metrics, and timely escalation.
  • Drive continuous improvement in operating models, workflows, digital systems, data governance, service delivery, productivity, and customer experience.

Education and Experience:

  • Education: Ph.D. in toxicology, biology, chemistry, biomedical engineering, or another related discipline. Other degrees and relevant experience will be considered.
  • 10+ years of progressively responsible experience in preclinical safety, toxicology, biocompatibility, regulated laboratory services, medical devices, or a closely related technical field.
  • Leadership experience: Demonstrated success leading managers and multidisciplinary scientific or technical teams within complex, highly regulated organizations.
  • Scientific breadth: Broad scientific expertise in toxicology, biocompatibility, biological evaluation, chemical characterization, and preclinical safety. The role requires broad scientific credibility.
  • Regulatory and quality knowledge: Demonstrated understanding of regulated product development and laboratory operations, including applicable GLP requirements and ISO/IEC 17025. Familiarity with ISO 10993 and global expectations for biological safety is strongly preferred.
  • Business leadership: Proven business leadership capabilities, including strategic planning, portfolio management, resource and capacity planning, budgeting and investment decision making (informed trade-off decisions).
  • Communication and influence: Excellent executive-level communication, presentation, and scientific writing skills, with the ability to effectively influence senior leaders, business partners, customers, regulators, auditors, auditors, and external stakeholders.

Knowledge and Skills:

  • Board certification or relevant professional credential, such as Diplomate of the American Board of Toxicology (DABT) or Regulatory Affairs Certification (RAC).
  • Experience supporting medical devices and combination products across innovation, development, regulatory submission, sustaining engineering, and post-market activities.
  • Experience leading enterprise laboratory networks, digital laboratory systems, data integrity, continuous improvement, and insourcing or outsourcing strategy.
  • Experience serving as GLP Testing Facility Manager, laboratory director, or equivalent executive quality-system accountability/leadership role.
  • Experience interacting directly with global regulatory authorities and representing an organization in standards committees, industry associates, or scientific forums.

Why Join Us?

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