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VP, Global Medical Safety, Governance and Operations

Apply Now Job ID R-347952 Date posted 09/11/2019

Job Description Summary

Job Description

The Vice President, Global Medical Safety, Governance and Operations is responsible for providing medical safety and pharmacovigilance oversight for BD’s portfolio of products throughout product life cycle, Medical Governance oversight for all Medical Affairs activities globally and Operations oversight, including strategic business reviews, budgeting and investment strategies in partnership with the business Medical Affairs leaders required to run the Medical Affairs organization. 

This position provides strategic thought leadership on the development of medical safety assessments (including Medical Affairs support for Adverse Event Reporting and  Pharmacovigilance assessment and reporting) and risk management documents in collaboration with the Chief Medical Officer as well as cross-functional, regional and business unit colleagues.  The VP ensures communication of potential and known risks, when appropriate, to the Chief Medical Officer and to relevant leaders in other functional areas (e.g. Quality, Regulatory, R&D, etc.).

This role also provides clinical oversight by virtue of Medical Monitoring which involves performing medical review of key study documents and safety information. The primary role of this capability is to set the framework and guidelines for medical monitoring and interacting with the necessary governance bodies (e.g., DSMB).

This role involves oversight to medical safety for a broad portfolio of products, services and solutions.  Working closely with business, regional and functional leaders, this role utilizes a lens for product medical safety when giving input to global medical, scientific and clinical development strategies that support the company’s strategic imperatives relative to new product approvals, acquisitions (due diligence) and product life cycle management.

The role is responsible for implementing corporate level medical product safety procedures and processes, building the capability to qualitatively analyze global product safety trends and their context, and standardizing the process for medical review of commercial materials.

This role also has oversight over the policies and procedures in handling medical information queries from customers and patients, and partners closely with medical leaders, quality and regulatory compliance in the business units and regions to assure standardization and compliance of these activities.  The role will oversee the existing Medical Governance, Human Subject Research and Product Safety governance boards.

Given the global reach of BD’s products and services, the VP, Global Medical Safety will provide medical oversight for Medical Information related to the BD’s Centers for Safety and Clinical Excellence (aka “Safety Centers) in partnership with the regions and/or BU to ensure coherence and consistency of medical content and information flow to customers and visitors.

S/he will provide motivational leadership, by instilling a bias for action, commitment to excellence, and a high-performing culture. This role has accountability to develop and maintain relationships with key opinion leaders and thought leaders in the industry, and will ensure that all business and medical safety activities are in accordance with applicable laws, rules and regulations of the intended markets meeting the highest quality standards and customer expectations.

The VP will report directly to the Chief Medical Officer and is an active member of the Company’s Medical Affairs Leadership Team.

Primary Responsibilities Include:

  • Leadership of medical safety, governance and operations, ensuring high value contributions in support of the company’s strategic goals.
  • Ensure that the impact of BD’s scientific and clinical submissions activities are included in the development of Company/Business Unit strategies.
  • Assurance that all medical safety activities are conducted according to highest domestic or international regulatory, quality and clinical standards including EU MDR/IVDR.
  • Developing, deploying, and maintaining a Medical Safety Review Board that provides the systems, processes and capabilities that enable the Company to monitor the medical aspects of patient safety, including clinical safety, pharmacovigilance and post market surveillance.
  • Accountable for patient safety throughout clinical development and on-market product life cycle.
  • Develops both long-term strategic and short-term operational plans designed to support the achievement of BD’s strategic imperatives. Anticipates, proactively pre-empts, and resolves problems and/or obstacles to ensure milestones and deadlines are met and project/program delays are minimized.
  • Regularly monitors the external environment. Develops and maintains a deep understanding of the industry.  Remains abreast of competitive development trends, industry practices, relevant legislation and customer needs.
  • Establishes expectations and monitors delegated activities of direct reports to accomplish business objectives and achievement towards annual operating plans. Develops leadership capabilities within their direct reports and future leaders.
  • Leads the identification, communication and management of potential and known safety risks
  • Is a vocal and visible champion of safety insights as a key input into product development and post market safety surveillance strategy
  • Develops and maintains a strategic plan to brand Medical Affairs and Global Medical Safety globally by various means of communication and education to both those internal and external to BD.
  • Build strong relationships between R&D, Quality, Regulatory, Clinical, and HEOR functions to allow for a proactive and flexible risk management system.
  • Oversight and input into design and interpretation of safety endpoints in collaboration with Global Clinical Development.
  • Have oversight and collaborate with Global Clinical Development with all matter associated with the safety of Investigator Sponsored Studies and Human Subject Research.
  • In partnership with Quality and Regulatory Compliance to monitor external sources/trends and identify and escalate emerging issues. These may include; complaint & medical device reports and vigilance trends, regulatory & market trends and intelligence, literature and scientific publications, review of adverse events and complaints.
  • Provide medical oversight for BD’s “Centers for Safety and Clinical Excellence (aka “Safety Centers)” to ensure high quality and compliant medical content and information flow, and work to standardize these across the company
  • Provides recommendations to EVP & Chief Medical Officer on Medical Affairs spend/budget allocation and resource deployment to ensure the optimal structure and resources are in place to execute the Medical Affairs strategy.

MINIMUM QUALIFICATION REQUIREMENTS

Education

  • Board Certified Physician (MD) with postgraduate training and at least 5 years of direct patient management/care experience required.
  • Experience within a large (>$10B), global medical device organization strongly preferred.
  • Minimum 15 years leadership experience in a related field with a minimum 5 years global people management experience in a highly matrixed, global environment at a senior level.
  • The candidate must have experience and demonstrated work in multiple therapeutic areas spanning medical devices and life sciences, and is capable of driving strategy, evidence generation, constructive challenge and problem solving.
  • Knowledge of basic statistical techniques is required; advanced statistical knowledge (e.g. multivariate data analysis) is desired.
  • Proven success in bringing new products to market; broad and deep expertise in the development and execution of robust clinical and scientific strategies spanning the development life cycle (proof of concept to commercialization), ideation, feasibility, development, clinical trials and clinical pull-through.
  • Successful track record in leading complex, global organizations responsible for the development and implementation of global medical safety programs in medical devices ranging from class I to class III, Premarket Approval (PMA) products, and associated pharmaceuticals to be used with our medical devices.
  • Expertise in the area of product safety compliance, post market surveillance, reporting, health hazard analysis and literature analysis.
  • Direct experience in and knowledge of business and management principles involved in tactical execution, strategic planning, resource allocation, human resources modeling, leadership, production methods, and coordination of people and resources.
  • Expertise in cellular therapy combination products and/or biologics is a plus.
  • Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential along with experience in interactions with all other health authorities.
  • Demonstrated success leading the development and implementation of complex organizational change efforts designed to continuously improve performance, adoption and execution of best-in-class processes, and application of scientific expertise to achieve or exceed organizational performance objectives.
  • Demonstrated success in leveraging program and project management disciplines, methodologies and practices to accomplish goals, objectives, timelines and milestones.
  • Demonstrated ability to manage budget, investment and human capital portfolios, including both in-sourced and out-sourced resourcing models is a plus.
  • Ability to work with effectively and influence leading decision-makers
  • Excellent communication skills, both written and verbal English.

Additional Requirements

Travel is required, given the global scope of the job, and would vary in intensity depending on the evolving business needs. Anticipated travel to be around 20-30%.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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