Job Description Summary

Job Description

We are the makers of possible!

BD's Corporate Development Department has responsibility for supporting the development and execution of both short- and long-term growth strategies of the Company and partnering with its worldwide business units, regions, and innovation center. Individuals in the Department identify, evaluate, value, structure and negotiate business opportunities including acquisitions, divestitures, strategic alliances, and equity investments. The Department develops and acts as an objective advisor regarding the strategic fit, valuation, and structuring of these numerous opportunities. Individuals in the Department are expected to provide overall project / deal management and, where appropriate, to work with the Leadership Teams of worldwide business units. Finally, the Department is responsible for shaping and executing BD’s corporate strategy as well as developing and maintaining valuation models and transactional, diligence and integration processes.

The Medical Director, Medical Safety Officer (Clinical) plays a pivotal role in establishing and maintaining a medical/clinical safety oversight and collaborative relationship with the BD Business Unit (BU) Medical Affairs.  This role is a function of the centralized BD Global Medical Safety and Governance (GMS&G) organization and reports directly to the V.P., GMS&G.

Responsibilities:

• Co-manage and support Clinical Safety Specialist (CSS) for their respective BU
• Responsibility in the area of Signal Detection/Safety Surveillance, evaluate and integrate data from multiple sources, including clinical, non-clinical and real-world to understand and manage safety signals and the communication of these issues to the VP, Global Medical Safety and Governance
• Oversight for central MA BD Pharmacovigilance
• Participation in oversight activities (e.g., Clinical Safety and Drug Safety Review Board core member) and providing clinical/medical expertise on individual event reports and signal detection methods
• Establish and maintain Clinical Safety training programs
• Establish and conduct monthly Clinical Safety Forums with the BU CSS
• Providing medical support for Risk Strategy, Risk Assessment, and Risk Minimization for BD products in partnership with other BD functions including Quality and Regulatory Affairs
• Support clinical safety data inquiries/Health Authority Responses
• Serve as a trusted partner to other R&D functions in representing the view on product safety and lead in a matrix environment through scientific competency and organizational influence and impact
• Contribute to departmental and cross-functional improvement initiatives
• Providing clinical/medical expertise in supporting activities such as participating on cross-functional teams such as SOP committees, taskforces, work streams and representing GMS&G positions, processes and guidance’s to cross-functional business partners

Qualifications:

• Understanding of the medical device development process
• Understands Good Clinical Practice and Safety Monitoring processes and regulations
• Understands and encourages a consistent approach to the Severity of Harm determinations used throughout the risk management process
• Knowledge of pharmacovigilance and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product
• Ability to leverage the range of available tools to investigate safety concerns
• Understanding of regulatory requirements for safety assessment and action
• Strong scientific analytical reasoning skills
• Ability to work on multiple complex projects in parallel
• Excellent attention to detail
• Behavioral competencies necessary to work and lead a team within a complex matrix environment
• Excellent verbal and written communication skills
• Medical degree (MD, D.O.) preferred, PharmD, P.A., APRN, or RN depending on Industry experience.
• At least 5 years of clinical trial experience
• At least 5 years of medical device industry and/or pharmaceutical experience, including experience in pre and post-market activities
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals

Primary Work Location

Additional Locations

Work Shift