Job Description Summary

Diagnostic Solutions (DS) is one of three global businesses within the Life Sciences segment. DS has a comprehensive array of infectious disease diagnostics for core labs, acute care settings, and point-of-care (POC). DS also has cervical cancer prevention solutions. Innovation is at the heart of DS, and we are developing new diagnostics that require clinical validation studies and regulatory approval. DS has three major platforms: Microbiology (growth-based microbiology with some molecular aspects), Molecular Diagnostics (infectious disease, HPV assay, cervical cytology), and POC. DS Medical Affairs has associates in international regions.

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.

The Senior Director, Clinical Affairs, Diagnostic Solutions reports directly to the Sr. Director, Global Medical Affairs - Strategy & Business Operations, Diagnostic Solutions. The Sr. Director of Clinical Affairs leads Clinical Affairs (clinical study management and monitoring operations) globally for the BD DS business. While the focus will be on excellence-level execution of clinical studies, the Sr. Director will also participate in clinical study design. It is expected that the Sr. Director will have two direct reports (a director, accountable for clinical study managers, and a manager, accountable for monitoring operations) and lead a team of 23 associates. Every clinical study has matrixed Medical Affairs associates aligned to Micro, Mol Dx, or POC; and associates from Scientific Affairs supporting the clinical studies.  

  

Responsibilities:

• Accountable for the successful execution of clinical studies including study management, monitoring operations, PIs, and CROs
• Interact with business unit and Medical Affairs leadership and cross-functional teams to define, implement, and execute clinical research strategies in support of business goals
• Oversee development and management of clinical studies, budgets, contracts, and resources
• Oversee continuous maintenance and communication of dashboards for individual clinical study projects and for the composite of all business unit clinical studies
• Oversee negotiation of contracting with CROs, sites, and labs, with or without support of procurement function
• Responsible for Clinical Affairs associates (clinical study managers and clinical research associates), including talent acquisition and talent development
• Subject matter expert on clinical study execution, including scientific rigor, good clinical practice, human subject protection, corporate standards/procedures, and regulations
• Assist in the development and submission of clinical reports to Regulatory Affairs
• Provide guidance to Regulatory Affairs associates on clinical strategy issues 
• Interface with Corporate Medical Affairs to develop processes and internal standards including the use of AI to support clinical affair deliverables
• Interface/liaison with Global Clinical Affairs leaders regarding study supplies, database builds, data management, statistical analysis, and HEOR

Qualifications:

• Undergraduate degree in a scientific discipline or related area. Advanced degree preferred (e.g. MSc, MD, PhD)
• SOCRA or ACRP credential highly preferred
• Experience in implementing AI solutions within clinical studies preferred
• Excellent written and verbal communication skills; ability to effectively present information in one-on-one and group settings to senior leaders
• Ability to review and evaluate scientific and technical data; knowledge of applied clinical statistics
• Thorough knowledge of FDA/international regulations and processes related to clinical research
• Ability to interface effectively with all levels and functions both outside and inside of the matrixed organization
• Ability and proven experience working cross functionally: partnering with and providing guidance to other functions on clinical requirements related to new product development and required approvals, regulatory affairs, quality assurance, marketing, and international requirements related to required clinical studies
• Self-confident and goal-oriented individual able to work in a fast-paced environment
• Collaborative solution finding and a sense of urgency
• Ability to mentor and support associates in a team environment
• Has experience with globa