Sr. Director, Clinical Affairs

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 global strategies for medical evidence generation to support new and existing products through regulatory approval, health technology assessment, and post-marketing support
• Expected travel up to 15%

Full-time Hybrid Role based in Sparks, Maryland: Hybrid at BD is 4 days a week in office, when not traveling.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. We require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.

Why Join Us?

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 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.

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

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Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information
$181,400.00 - $326,500.00 USD Annual