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BD (Becton, Dickinson and Company) Senior Director CPDT (Corporate Preclinical Development and Toxicology) in Research Triangle Park, North Carolina

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Our vision for Senior Director, CPDT at BD

Design and oversight of programs (internal and external) to address biocompatibility, toxicology, and related aspects of lab animal research; and preclinical safety, efficacy and compliance of all BD products (medical devices, drugs, biologics, diagnostics and combination products). Includes establishment and maintenance of digital systems for request and tracking of work in all categories.

About the role:

The Sr Director has direct organizational accountability for BD CPDT COE and shared responsibility for the development, scheduling and maintenance of BD’s Large Animal Research Program, including a current staff of 108 (associates, temporaries and consultants). and an annual budget of $22.5 million. The specified functions and responsibilities apply to all medical device, combination and/or therapeutic products, inclusive of worldwide and local safety and regulatory requirements. This role is accountable to ensure support to innovation, portfolio delivery and revenue generation in areas of responsibility. It supports risk management activities as defined by the businesses.

Key responsibilities will include:

  • Design and oversight of programs (internal and external) to address biocompatibility, toxicology, and related aspects of lab animal research; and preclinical safety, efficacy and compliance of all BD products (medical devices, drugs, biologics, diagnostics and combination products). Includes establishment and maintenance of digital systems for request and tracking of work in all categories.

  • Primary liaison between preclinical and clinical aspects of product safety and efficacy programming for BDX globally

  • Provide expertise and core competency for Corporate Regulatory activities in product approvals, post-market support and customer management

  • Functional lead for business strategy collaborations and support, product development partner with R&D

  • Functional lead for cross-functional strategic programs and activities, including Global Sustainability, QA, RA, MA and others as identified

  • Provide direct customer facing support related to product safety, efficacy and compliance

  • Represent BD in external industry advocacy groups and/or standards groups

  • Represent BD in Regulatory Agency interactions worldwide, including product clearance reviews, audit support, etc.

  • Develop and lead the functional CPDT organization to reflect BD strategy and vision, including support to growth and innovation, talent management and efficiency. Align with BD 2025 vision and Grow, Simplify and Empower initiatives.

  • Provide internal consultation on policies and practices related to preclinical sciences (pharmacology and toxicology, in vivo model design and execution) and safety to address BD interests and issues

  • Maintain an environment of compliance with Good Laboratory Practices (GLP) and ISO 17025 Quality Systems, continuous improvement and quality, aligned with BD core values and strategic objectives.

Scope of Responsibility:

  • Assure that appropriate preclinical safety and efficacy evaluations are specified and executed in accordance with the principles of the ISO 10093 guidelines, FDA regulations, GLP regulations, ISO 17025 and when specifically indicated, with any other applicable national and/or international standards. Such evaluations may include pharmacology, toxicology, efficacy assessments and in vivo preclinical models for relevant products and applications (see also Corporate Policy CPO-124).

  • Lead strategic development and implementation of BD CPDT in response to the needs of BD product development, strategic directions, marketing, and regulatory requirements. Major elements include appropriate technical competencies and centralized functions in biological and chemical testing, lab animal research, as well as operations (PMO), Lab Informatics and Quality Management.

  • Lead the global organization providing scientific expertise, consultation, program strategy, study design and execution, external liaison support; with current locations in CA, IL, NJ, NC, AZ, UT, Europe (Ireland, France) and Asia (China). Responsible for cohesive program to address COE deliverables for all BU and BDX level activities in areas of accountability.

  • Contribute functional and strategic expertise to Corporate level initiatives, e.g. due diligence activities, public policy and communications, and customer requirements.

  • Develop and implement a departmental organizational structure to address BD 2025 vision and BDX Grow, Simplify and Empower strategy, with emphasis on Strong Central Team value:

  • Support adjunct Functions; including Global Sustainability, Regulatory Affairs, Quality

Assurance, TGS and Medical Affairs:

  • Support the BD Enterprise R&D Sustainability Program via the Chemical Review Board and the Product Impact Council, with a focus on Materials of Concern and Sterilization.

  • Support Regulatory Affairs in international product registration workstreams

  • Contribute to Inspire Quality initiatives with specific focus on Data Integrity, data management, documentation security and management, BDX level Quality Compliance.

  • Collaborate with all BDX project teams in definition of appropriate preclinical programs for product development(s). Proactive contribution to early-stage product development, GPDS, Innovation via new engagement/collaboration model.

  • Consult with the appropriate Corporate and Business Segment personnel concerning technical issues of product safety and efficacy evaluation. Provide expertise and support for critical evaluation of materials components, final products and/or competitive products; investigation and response to product complaints; and interface with regulatory bodies as necessary.

  • Coordinate personnel activities of department management staff, including hiring, training and performance review. Perform periodic review of departmental personnel performance in accordance with Corporate guidelines and strategic objectives. Coordinate and monitor contract laboratory services as required, ensure service meets client needs and timetables.

  • Prepare the departmental operating and capital expenditure budget and provide budget information as requested on a timely basis. On a regular basis, provide rationale for current department expenditures and/or proposed changes.

  • Continue refinements of workflow management capabilities to include departmental performance metrics, business SLAs and resource management (e.g., work costing models, in-sourcing strategy and savings metrics, transparency and improved planning with BUs)

  • Lead continuous improvement initiatives to define, map and improve the efficiency and quality of processes across CPDT:

  • Define and assemble cross-functional teams to address PM issues and needs as identified by either the client BUs or internal CPDT associated.

  • Assist project sponsors to develop project charters and form appropriate teams

  • Map the current (as-is) state and future (to-be) state

  • Facilitate data gathering and root cause analysis of the issue

  • Facilitate solution determination

  • Assist in the development and implementation of the change management plan

  • Assist in the identification of key performance indicators to measure project success and apply technical communication expertise to create documentation as defined by the project or management as needed.

  • Act as PM lead for external Business Unit (client) relationship management; ensure alignment on client portfolio demands, collaborate with CPDT leadership on resource planning, and manage delivery of projects as needed. Manage digital platforms to record and track work in compliance with Regulatory standards.

  • Develop appropriate dashboards and metrics for BU programs/activities as required.

  • Serve as primary liaison with Business Unit PMOs, support communications of CPDT strategies, and operational outcomes.

  • Collaborate with CPDT management and technical leaders in the department, as well as business unit stakeholders to understand and coordinate delivery of CPDT services portfolio.

  • Align with CPDT SMEs on internal CPDT programs, budgets/resources, etc. Collaborate on systems developments to support overall strategy and mission (e.g. Lab Informatics for regulatory tracking).

  • Collaborate with CPDT SMEs on cost/content models and effective planning/tracking

  • Interface with BDX functions and BUs regarding COE programs (e.g. MDS COEs, Corp QA initiatives), advise on CPDT participation model

  • Drive comprehensive RACI development for internal operations and interfaces with BUs

  • Demonstrate best in class program management practices and drive those practices within all active programs

  • Drive cross-functional planning and effective execution of CPDT programs through the development and monitoring of integrated timelines and budgets (as appropriate to scale of program).

  • Lead coordination of project activities and resources across the organization to maximize efficiency and minimize conflicts

  • Continuously improve PMO processes, tools, metrics, and policies ensuring they meet customer needs and drive productivity, quality and business success

  • Implement current local safety programs and maintain the required level of safety literacy by including safety issues as part of laboratory meetings.

  • Maintain knowledge of activities in the medical, product and regulatory arenas to assure compliance and conformance of BD CPDT programming; to include medical devices as well as drugs, biologics and/or diagnostics as necessary.

  • Develop appropriate policies involving preclinical toxicology and product safety and efficacy directives, and effectively train affected BD associates on impact and application.

  • Establish and support a quality assurance and quality management program for the department and laboratory operations that is consistent with all pertinent regulatory and corporate strategic requirements, to include GLP and ISO 17025 compliance.

  • Maintain an environment of continuous improvement and quality in alignment with BD core values and strategic objectives, including ongoing assessment of capabilities, open communication, infrastructure development, and staff/talent acquisition and management.

  • Provide oversight for BD Corporate Policy for Laboratory Animal Care and Use, including responsibility for the BD Animal Policy Oversight Committee. Maintain oversight and governance responsibility for all preclinical studies (including in vivo studies) per CPO-124.

  • Contribute to BD Sustainability Report and related messaging in areas of Lab Animal Research and Sustainability initiatives noted above.

  • Implement programs in support of new/emerging external demand drivers (e.g. legal requirements like the EU Medical Device Regulation), with necessary application of technical expertise as well as direct testing strategies and execution.

About you:

To be successful in this role, the preferred experience is the following:

  • Ph.D. in toxicology or a closely related field (e.g. analytical chemistry for material characterization and safety assessment) or DVM (DACLAM); with 10+ years of experience

  • Board certification in toxicology (American Board of Toxicology) or veterinary medicine (Academy of Laboratory Animal Medicine) required.

  • Broad background in biology/toxicology and chemistry including familiarity with recent methodologies and evaluation techniques is required. Extension of laboratory results to the construction of formal toxicologic material risk assessment documentation per current international standards.

  • Demonstrated experience in superior scientific writing

  • Significant supervisory experience with proven ability in staffing, project management and budget preparation.

  • Knowledge of regulatory guidelines for the medical device and therapeutics sectors, as well as an ability to communicate and work effectively across a wide national and international internal client base.

  • Supportive/collaborative interactions with all BD segment and corporate functions are required on a routine basis. Strong assessment and analytical skills, ability to determine key issues, develop effective action plans and implement to successful conclusions

  • Certification in Project Management (PMP certification preferred) and at least three years’ experience in leading projects and project teams, including operations project management or project coordination in biocompatibility and chemistry testing in a GLP regulated and ISO 17025 compliant laboratory

  • Training or certification in Six Sigma/Lean methodologies (Green Belt certification preferred), facilitation of Kaizen events, and working knowledge of process improvement tools. Project team experience in local and enterprise IT projects with FDA 21CFR Part 11 requirements.

  • Ability to envision future state business services/processes and construct roadmaps to future states. Proven understanding of PMO model and functionality.

  • Subject matter expert in best practices of program management.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

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

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

Primary Work Location

USA NC - Research Triangle Park

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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