VP, Global Clinical Affairs, Peripheral Intervention (PI)

Job Description Summary

Job Description

We are the makers of possible.

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.     

BD at a glance

BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety, and expand access to health care.

Key BD Facts (FY’23)

• $19.3B Revenue

• Three segments: Medical ($9.5B), Interventional ($4.7B), Life Sciences ($5.1B)

• 40B+ devices made annually

• 190+ countries served

• $1B+ annual R&D investment and five global enterprise R&D centers of excellence

Our values: We do what is right; We thrive on innovation and demand quality; We are accountable; We learn and improve every day; We help each other be great.

Opportunity:

Vice President of Clinical Affairs, Peripheral Intervention (PI)

Core Experience Summary:

• 15 years plus minimum experience

• Prefer small, medium, and large company experience

• Must have IDE, PMA, RWE, HEOR experience

• Mastery of pathway to market – clear multiple examples of bringing med device products from conception to market

• Examples of running multiple studies simultaneously

• Prior experience with real-world evidence publications

Leadership:

• Experience leading Clinical Affairs teams; Energetic, charismatic change agent who is viewed by current and previous direct reports as a truly inspirational leader.

• Examples of shaking up the status quo in a positive way.

• Clear experience of operating independently and not being directed on a daily basis.

• Current experience sitting on the senior leadership team of their company/business: Ability to interact regularly and effectively with fellow senior leaders.

Role based in Tempe, Arizona (Relocation assistance provided); Hybrid at BD is 4 days a week in office, when not traveling. Expected travel up: to 40%

Segments at BD:

BD consists of three segments: BD Medical (Transforming medication preparation and administration and creating better medical outcomes), BD Life Sciences (Investing in transformative solutions around smart, connected, end-to-end workflows and collection and diagnostics), and BD Interventional (BDI) (Empowering healthcare workers to reduce the incidence of surgical complications, improve patient outcomes in chronic disease and lower the total cost of care).

BD Interventional (BDI) segment (approx. $5B in revenue) focuses on developing innovative surgical, endovascular, urological and critical care interventions that not only meet clinical needs but also deliver value to health systems and improve patients’ lives. 2 out of 3 selected surgical, peripheral, and urological interventions use a BD device, aimed at advancing the treatment of high burden diseases and enabling surgical and interventional procedures. There are three business units in BDI: Surgery; Urology and Critical Care (UCC), and Peripheral Intervention (PI).

BD Peripheral Intervention (BDPI) - one of three global businesses inside the BD Interventional Segment

• Revenue: ~$1.9B

• Offering a comprehensive range of minimally invasive solutions and devices to diagnose, treat, and manage progressive and often undiagnosed diseases like cancer, end stage kidney disease, and peripheral arterial disease.

• The BDPI approach includes game-changing technologies, clinical education, disease awareness programs, and market access efforts to help clinicians, institutions, and advocacy organizations to advance the future of treatment and minimize the impact of these diseases on patients

The role:

The Vice President of Clinical Affairs, Peripheral Intervention (PI) reports directly to the VP of Medical Affairs, PI & Enterprise Clinical Excellence, JD Meler, MD with direct accountability to the WW President, Peripheral Intervention (PI), Rima Alameddine. The VP of Clinical Affairs PI leads Clinical Affairs (Clinical Affairs/Operations, Scientific Affairs) globally for the BD Peripheral Intervention business. The VP of Clinical Affairs PI will build and drive robust evidence generation programs for the BU, leveraging or building capabilities for success in evidence generation, and guiding programs across the continuum of evidence needs (e.g., regulatory clinical studies, post-marketing studies, and collaborating with HEOR/Reimbursement clinical studies). 

Responsible for high-level oversight of Clinical Affairs activities related to the design, implementation, and initiation of clinical trials, guiding Scientific Affairs related to publication/podium content/strategy, both in the US and Internationally.  This position will work closely with the VP of Medical Affairs PI to ensure proper medical/clinical content is evident in all studies, presentations/publications, and educational programs. 

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

• Oversee the Clinical Affairs, Scientific Affairs functions

• Interact with business unit leaders and Corporate management (and cross-functional) teams to define, implement, and execute clinical strategies in support of business objectives.

• Oversee the development and management of clinical studies, presentations/publications, budgets, contracts, and resources.

• Oversee evidence generation activities for compliance with protocols, corporate standards/procedures, regulations, and Good Clinical Practices.

• Assist in the development/execution of evidence generation policies, goals, and reports.

• Assist in the development and submission of clinical reports to Regulatory Affairs

• Provide guidance to Clinical/Regulatory Affairs staff on clinical strategy issues between BDPI and FDA (and other regulatory bodies).

• Drive strategy for BDPI and physician generated clinical data utilization in close collaboration with key stakeholders.

• Develops and fosters strong relationships with key opinion leaders and investigators through direct interactions to drive evidence generation and training objectives

• The successful candidate must possess a strategic mind and be able to visualize a potential clinical strategy beyond the traditional approach.

• Work closely with the VP of Medical Affairs to develop KOL database and relationships.

• In conjunction with the VP of Medical Affairs, provide accountability for the review and approval of requests for educational grants, scientific information, and investigator-initiated research grants.

Education and/or Experience:

• Undergraduate degree in a scientific discipline or related area. Advanced degree preferred.

• A minimum of 15 years of experience in Clinical Affairs and /or Regulatory Affairs: Must have a minimum of 7 years managing a clinical affairs function in the medical device industry.

Required Qualifications:

• Thorough knowledge of FDA/international regulations and processes related to clinical research.

• The ideal candidate will also demonstrate proficiency and effectiveness in scientific and operational matters related to clinical program development, implementation & execution.

• Excellent written and verbal communication skills

• Ability to review and evaluate scientific and technical data.

• Ability to interface effectively with all levels and functions both inside and outside of the organization.

• Self-confident and goal oriented individual able to work in a fast-paced environment that also operates with a sense of urgency.

• 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.

• 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.

• Working knowledge of US and International regulations governing the medical device industry.

• Excellent interpersonal, communication (verbal and written) and problem solving skills.

• Ability to mentor and support employees in a team environment.

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations.

• Ability to effectively present information in one-on-one and group situations to sr. leaders, customers, clients, and other associates of the organization

• Strong ability to communicate well with leaders at the most senior levels in the organization.

BD Critical Leadership Capabilities

Collaborating and Influencing; Leading People; Strategic Thinking; Driving Results; Desired Outcomes

Fundamental Personal Characteristics

• Lives BD's values

• Agile learner

• Strong, demonstrated business ethics

• Servant leader

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. For most roles, 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. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. 

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

.

Primary Work Location

Additional Locations

Work Shift