Senior Director, Corporate Preclinical Development and Toxicology

HITEC; Durham (NC); On-site; USD 180,000 - 230,000; Full time

Job summary

BD, a leading medical technology company, seeks a strategic leader for the CPDT organization. You will guide toxicology, biocompatibility, and preclinical safety programs, ensuring GLP and ISO/IEC 17025 compliance while aligning resources with BD’s portfolio and regulatory expectations.

You will direct a diverse, expert team, manage budgets, and partner with R&D, Regulatory, and Quality to drive product development and post-market activities.

Qualifications

• Ph.D. required or equivalent senior experience in regulated lab services.
• Demonstrated leadership of managers and cross-functional teams in highly regulated settings.
• Broad expertise in toxicology, biocompatibility, chemical characterization, and preclinical safety.

Responsibilities

• Provide strategic and operational leadership for CPDT, aligning with BD strategy.
• Oversee programs on toxicology, biocompatibility, chemical characterization, and preclinical safety.
• Lead Testing Facility Management for GLP studies with proper facilities, equipment, and quality oversight.
• Own CPDT Quality Management System and compliance with GLP, ISO/IEC 17025, and data integrity.
• Direct scientific and regulatory decisions balancing safety, costs, schedules and portfolio priorities.
• Collaborate with R&D, Regulatory, Quality, Medical Affairs, and other stakeholders.

Skills

Leadership

Executive communication

Regulatory knowledge

Toxicology breadth

Quality systems

Strategic planning

Budgeting & investments

Education

Ph.D. in toxicology, biology, chemistry, biomedical engineering

Job description

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?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

USA NC - Durham - Davis Drive