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BD (Becton, Dickinson and Company) Director Global Clinical Affairs in Franklin Lakes, New Jersey

Job Description Summary

The BD Corporate Clinical Affairs team advances the world of health through design, development, and generation of evidence. Reporting to the Global Vice President, Clinical Affairs (CA), this position, Director of Corporate Clinical Affairs, will lead and oversee the execution of clinical evidence for the Integrated Diagnostic Solutions (IDS) business unit partnering with the Business Unit Medical Affairs team and stakeholders. The ideal candidate will demonstrate proficiency and effectiveness in scientific and operational matters related to clinical program development, implementation & execution. This position has the responsibility to provide clinical, scientific, and technical customer-focused leadership and perspective, and is responsible for the evidence generation planning and execution; while aligning regulations and business needs.

Job Description

Job Description

The BD Corporate Clinical Affairs team advances the world of health through design, development, and generation of evidence. Reporting to the Global Vice President, Clinical Affairs (CA), this position, Director of Corporate Clinical Affairs, will lead and oversee the execution of clinical evidence for the Integrated Diagnostic Solutions (IDS) business unit partnering with the Business Unit Medical Affairs team and stakeholders. The ideal candidate will demonstrate proficiency and effectiveness in scientific and operational matters related to clinical program development, implementation & execution. This position has the responsibility to provide clinical, scientific, and technical customer-focused leadership and perspective, and is responsible for the evidence generation planning and execution; while aligning regulations and business needs.

Main Responsibilities

  • Lead and develop a team of clinical program and project managers and clinical research associates

  • Develop strategies and scenarios for evidence generation e.g trials, surveillance etc.

  • Adhere to Good Clinical Practices (GCP), local and global policies and procedures to conduct high-quality, inspection ready studies

  • Develop and execute forecasts to include; resources, budgets and timing using appropriate clinical cost drivers

  • Build relationships with BU Medical Affairs Stakeholders to understand value drivers for evidence generation and dissemination; study design and execution of clinical studies.

  • Develops and fosters strong relationships with key opinion leaders and investigators through direct interactions to drive evidence generation and dissemination

  • Lead Portfolio Reviews with BU and cross functional stakeholders

  • Prepare and succeed for audits and self check by internal audit team and external inspection body

  • The successful candidate must possess a strategic mind, able to visualize a potential clinical strategy beyond the traditional approach

  • Demonstrated experience managing clinical affairs functions in the medical device industry and a thorough knowledge of FDA/international regulations and processes related to clinical research

Qualifications

  • Undergraduate degree in a scientific discipline or related area. Advanced degree preferred

  • A minimum of ten (10) years of experience in combined Clinical Affairs and/or Regulatory Affairs

  • More than eight (8) years of experience leading and developing high functioning clinical affairs teams

  • Excellent written and verbal communication skills, in English

  • Experience authoring scientific, high quality clinical study protocols

  • Ability to review and evaluate scientific and technical data

  • Ability to interface effectively with all levels and functions both inside and outside of the organization

  • Self confident and goal oriented individual able to work in a fast-paced environment that also operates with a sense of urgency

  • Operational and Working Knowledge of Clinical Trial Design Regulations GCP; ISO14155; GDPR; HIPAA etc.

  • Project management (PMP)

  • Microsoft OFFICE proficiency including Project

  • Compliance and Quality mindset

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.

Primary Work Location

USA NJ - Franklin Lakes

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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