Director Global Clinical Affairs, BU Lead - Remote/Hybrid
Job Description SummaryBE 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 Director, Global Clinical Affairs (a key leadership role within Global Clinical Affairs (GCA)) supports the Specimen Management, Micro, and Women's Health platforms within the Integrated Diagnostic Services business unit. This role will support corporate objectives by advising the daily activities of Clinical Affairs personnel to deliver high-quality clinical evidence generated on time and within budget.
The ideal candidate will demonstrate a proven track record to independently facilitate and lead a highly functioning team by providing department personnel direction, oversight, and developmental support. The ideal candidate will have a consistent record working as a laboratory manager or Director and conducting clinical research. The candidate must show skill and efficiency in scientific and operational matters related to clinical program development, clinical trial design, clinical study strategy, implementation, and execution.
This function provides the critical connection between the IDS Business Unit, regionally-based Medical Affairs (MA) teams, and GCA. This role will sit on the Specimen Management MA Leadership team within the BU/Region to ensure strategic alignment between the BUs, Regional MA, and GCA on Evidence Generation and Dissemination Strategy.
Primary Responsibilities and Duties
- Plan and strategize with the internal Business Unit management cross-functional teams (R&D, Marketing, Quality, and other business partners) to define, implement, and execute global clinical strategies in support of business objectives
- Plan and coordinate departmental and project resources, timeline, and budgets
- Effectively communicate with Business Unit and Medical Affairs Management teams.
- Lead and guide Clinical Program Managers and Clinical Affairs professionals
- Oversee the development and management of evidence generation and dissemination, budgets, contracts, and required resources
- Oversee clinical programs for compliance with protocols, corporate standards and procedures, regulations, and Good Clinical Practice guidelines
- Oversee compliance in reporting (clinical study reports, notified bodies, ct.gov)
- Serve as a Subject Matter Expert on initiatives supporting executive leadership team initiatives.
- Provide Subject Matter Expertise during due diligence reviews for business development (M&A) activities
- Understands BD culture and values and reflect them in their behavior
- Evaluate and monitor external and internal trends and business needs pertaining to GCA activities.
- Drives innovation and continuous improvement for the GCA by evaluating and monitoring external trends in best practices for evidence generation and dissemination and regulatory requirements worldwide to identify relevancies to BD.
- Serves as a representative to other key BD initiatives and is a liaison with other BD activities in the area of portfolio management and resource management with other functions or external organizations
- May perform other duties as required.
Education & Experience
- Bachelor's degree required, with advanced degree preferred (e.g., MS, MPH, MBA, Ph.D., PharmD, MD).
- Minimum 12 years of relevant experience in pharmaceutical; laboratory, or medical device clinical affairs function
- Experience in managing large, complex projects and successfully establishing and implementing near- to medium-term functional strategies across medium to large-sized organizations
- Minimum ten years of experience mentoring, leading, and developing individuals and organizations and managing resources across multiple competing projects.
- Demonstrated excellence in resource management within complex portfolio development
- Strong knowledge of: clinical study design, laboratory workflow, FDA medical device regulations, Federal and State laws governing clinical research, human subject protection, and HIPAA.
- Certification of Good Clinical Practice (GCP) is required.
- Demonstrated ability to establish and lead a successful team.
- Demonstrated ability to establish and build successful collaborations with internal peers and senior management across multiple disciplines, businesses, regions, and organization levels.
- Strong project planning, project management, leadership, negotiation, writing, and presentation skills
- An ability to contribute creative yet practical solutions to problems
- Ability to manage several projects in parallel, with appropriate attention to detail.
- Ability to make decisions with limited data and work effectively in a rapidly changing and ambiguous environment.
- Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of work and resolve the problems in a timely fashion
- Outstanding communication skills, oral and written, required
- Knowledge of and experience in portfolio management and associated tools
- Travel is estimated to be < 30%, US and internationally
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 LocationUSA NJ - Franklin Lakes
Additional LocationsUSA MD - Sparks - 39 Loveton Circle
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ