BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
The Director, Clinical Operations is responsible for the development and management of the clinical operations function in support of the Specimen Management product development and overall business objectives. The Director assures compliance with applicable regulations regarding all pre-market clinical study activities as defined within BD procedures. The Director provides strategic direction for clinical execution of projects in support of regulatory approval. This individual is a subject-matter expert in clinical operations management and execution.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
Utilize technical clinical operations skills to propose strategies on complex issues.
Provide clinical input to product lifecycle planning.
Provide strategic input and technical guidance on clinical requirements to development teams.
Manage pre-approval clinical study activities conducted by Clinical Research Associates and Clinical Study Managers.
Monitor impact of changing regulations on submission strategies and update internal stakeholders.
Support and review regulatory submissions as required in addition to reports and responses to regulatory authorities.
Ensures efficient execution of studies within established budgets and timelines, and in compliance with BD policies and procedures, appropriate regulations, including FDA, privacy, ICH requirements, and other local requirements as applicable.
Serves as a subject matter expert (SME) on clinical trial execution, including scientific rigor, good clinical practice (GCP) and human subject protection.
Establish and maintain relationships with alliance partners, external companies, investigators and key opinion leaders to optimize performance on clinical trial activities.
Review and approve required protocols and clinical reports, supplemental submissions
Provide training for clinical operations group on good clinical practices and for stakeholders on current and new clinical requirements to ensure company-wide compliance.
Develop and maintain business unit SOPs/processes for clinical research.
Interface with Corporate Medical Affairs on developing processes and internal standards.
Other projects assigned.
Minimum M.S. Science, or other relevant technical degree with minimum 10 years of leadership experience in clinical affairs. Advanced degree (e.g. MPH, PhD) preferred.
• Previous experience with managing CRAs and study managers.
• SOCRA or ACRP credential highly preferred
• Broad knowledge and experience with clinical affairs regulations and implementation.
• Demonstrated track record of managing multiple studies from initiation through completion with resulting in successful marketing authorization, publications, and establishment of broadened indications and claims for medical devices.
• Knowledge of IVD products quality system principles and GCP concepts, practices and procedures.
• Ability to work independently with confidence, resolve conflicts, and negotiate with a “win-win” approach.
• Ability to work in a matrix/team environment with prior significant experience supervising clinical affairs professionals. Solid skill in written and oral communications.
• Positive energy and enthusiasm to work in a multi-task environment.
• Existing professional and scientific interfaces with professional societies and governmental regulatory agencies.
• Ability to travel as needed, up to 15%.
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve 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. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
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.
Required Skills
Optional Skills
.
Algofy
TechnicAtome
Creative Fabrica
Filta.
The Arbitrum Foundation
