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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.

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 “function or BU” at BD

The Senior Director has direct organizational accountability for the BD Corporate Preclinical Development and Toxicology Center Of Excellence technical functions 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). Annual budget of $22.5 million. (NOTE: in the planned design, there will be parallel leaders for business/PMO, and the LAR COE (2). This role will oversee the core technical functions with approximately 60 staff and a budget of about $18M).

The specified functions and responsibilities apply to all medical device, combination and/or therapeutic products, inclusive of worldwide and local safety and regulatory requirements.

About the role:

As Senior Director, CPDT you will have responsibility for design and oversight of programs (internal and external) to address biocompatibility, toxicology, and analytical chemistry for preclinical safety, efficacy, and compliance of all BD products (medical devices, drugs, biologics, diagnostics, and combination products). (NOTE: this will actually fall under the business/PMO Sr. Director)

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:

  • 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 other applicable national and/or international standards.

  • Lead strategic development and implementation of BD CPDT in response to the needs of BD product development, strategic directions, marketing, and regulatory requirements.

  • Oversee the global organization providing scientific expertise, consultation, program strategy, study design and execution, external liaison support.

  • Collaborate with CPDT PMO to continuously improve PMO processes, tools, metrics, and policies ensuring they meet customer needs and drive productivity, quality, and business success

About you:

  • 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.

  • 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

  • Strong assessment and analytical skills, ability to determine key issues, develop effective action plans and implement to successful conclusions

  • 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

Education and experience:

  • Ph.D. in toxicology or a closely related field (e.g. analytical chemistry for material characterization and safety assessment)

  • Board certification in toxicology (American Board of Toxicology) required

  • Project team experience in local and enterprise IT projects with FDA 21CFR Part 11 requirements (preferred)

  • Certification in Project Management (PMP certification preferred) or at least five 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

  • Working knowledge of process improvement tools highly desirable.

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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