Senior Director, Corporate Preclinical Development and Toxicology

Becton Dickinson Medical Devices•Durham, NC

About The Position

The Senior Director, Corporate Preclinical Development and Toxicology provides strategic, scientific, operational, and organizational leadership for Corporate Preclinical Development and Toxicology (CPDT), aligning capabilities, priorities, investments, and service delivery with BD’s strategy and portfolio needs. The role oversees internal and external programs in toxicology, biocompatibility, chemical characterization, and preclinical safety for medical devices and combination products. The position provides executive leadership for the CPDT Quality Management System and serves as Testing Facility Management for applicable Good Laboratory Practice studies. It ensures appropriate personnel, facilities, equipment, methods, quality oversight, and corrective actions, and maintains compliance with applicable GLP requirements, ISO/IEC 17025, data integrity expectations, and internal quality requirements. The role balances patient and user safety, regulatory expectations, quality, cost, schedule, and portfolio priorities. The Senior Director partners 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. The role represents BD with regulatory authorities, customers, auditors, industry organizations, standards committees, and external scientific partners, and translates complex scientific and regulatory matters into clear recommendations for executives and cross-functional teams. The role leads and develops a diverse organization of scientific, technical, quality, project management, informatics, and business professionals, focusing on succession, capability, engagement, and accountability. It also owns financial and resource stewardship, including budgets, forecasts, capacity planning, external spending, vendor strategy, cost models, and investment trade-offs. The Senior Director establishes portfolio priorities and resource allocations using transparent criteria, governance, metrics, and timely escalation, and drives continuous improvement in operating models, workflows, digital systems, data governance, service delivery, productivity, and customer experience. The position is based at BD’s primary work location in Durham, North Carolina. BD describes a culture that values face-to-face collaboration to support learning, progress, and success.

Requirements

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.
Demonstrated success leading managers and multidisciplinary scientific or technical teams within complex, highly regulated organizations.
Broad scientific expertise in toxicology, biocompatibility, biological evaluation, chemical characterization, and preclinical safety.
Demonstrated understanding of regulated product development and laboratory operations, including applicable GLP requirements and ISO/IEC 17025.
Proven business leadership capabilities, including strategic planning, portfolio management, resource and capacity planning, budgeting, and investment decision-making.
Excellent executive-level communication, presentation, and scientific writing skills, with the ability to influence senior leaders, business partners, customers, regulators, auditors, and external stakeholders.

Nice To Haves

Familiarity with ISO 10993 and global expectations for biological safety.
Board certification or a 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 in an equivalent executive quality-system accountability or leadership role.
Experience interacting directly with global regulatory authorities and representing an organization in standards committees, industry associations, or scientific forums.

Responsibilities

Provide strategic, scientific, operational, and organizational leadership for CPDT, aligning its 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 GLP 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 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 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.