BD (Becton, Dickinson and Company) Global Director, Medical Affairs, IDS Specimen Management in Franklin Lakes, New Jersey
Job Description Summary
Medical Affairs Director for the pre-analytic specimen management business group of Integrated Diagnostic Solutions.
BD (”BD” or the “Company”), one of the largest global medical technology companies in the world, is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The Company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a mission and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD’s long-term strategy is focused on providing leading medical technologies and innovative solutions for their customers and their patients, and driving sustainable healthcare by increasing access, driving better outcomes, mitigating system cost pressures, and improving health care safety, through:
Life Sciences: Enhancing the diagnosis of infectious disease and cancer; empowering research insights inside and outside the cell
Medical: Improving medication management across the continuum of care; leading in infection prevention and health care safety
Interventional: Advancing the management of high burden diseases; enabling surgical and interventional procedures
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. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare. In 2017, BD welcomed C. R. Bard and its products into the BD family.
BD Life Sciences Segment / Integrated Diagnostic Solutions (IDS) / Specimen Management Business Group
BD Life Sciences provides products for the safe collection and transport of diagnostics specimens, and instruments as well as reagent systems to detect a broad range of infectious diseases, healthcare-associated infections (“HAIs”) and cancers. In addition, BD Life Sciences produces research and clinical tools that facilitate the study of cells, and the components of cells, to gain a better understanding of normal and disease processes. That information is used to aid the discovery and development of new drugs and vaccines, and to improve the diagnosis and management of diseases. The primary customers served by BD Life Sciences are hospitals, laboratories and clinics; blood banks; healthcare workers; public health agencies; physicians’ office practices; academic and government institutions; and pharmaceutical and biotechnology companies.
The Specimen Management Business Group resides within BD’s Integrated Diagnostic Solutions Business Unit which is located within the BD Life Sciences Segment. The Specimen Management Business Group comprises integrated systems for specimen collection and safety-engineered blood collection products and systems. BD works in collaboration with healthcare professionals, industry partners and opinion leaders to maintain uncompromising standards of quality, integrity and safety. As the field of diagnostic testing continues to present complex and developing phenomena, BD is assuming a leadership role in the diagnostic industry to ensure the highest level of excellence for their products, services and programs. Since 1943, BD Life Sciences – Specimen Management’s traditions of innovation, customer focus and putting both the healthcare worker and patient first have helped the Company to transform emerging challenges into opportunities for even greater accuracy and product dependability.
Specimen Management’s full range of products includes:
BD Vacutainer® blood collection tubes.
Safety engineered devices such as the BD Vacutainer® EclipseTM blood collection needle and BD Vacutainer® Push Button UltraTouchTM blood collection sets, which allow for collection from patients of all types with the added benefit of protecting healthcare workers from the risk of needle stick injuries.
BD Microtainer® tubes for paediatric patients and capillary sampling used to collect blood with BD Lancets.
BD Vacutainer® urine collection system for the collection and transport of urine samples.
BD Vacutainer® blood collection adapters which are compatible with all BD Infusion devices.
BD Critical Care Collection syringes including safety products for arterial blood collection and analysis.
A novel capillary blood acquisition device and BD Microtainer® tubes
A range of Molecular Diagnostic and biomarker products.
Role / Responsibilities:
Reporting to the Vice President, Medical Affairs, BD Integrated Diagnostic Solutions (IDS), the Global Director, Medical Affairs, Specimen Management plays a crucial role in influencing key business decisions within Specimen Management Medical Affairs, leading Medical Affairs participation in product development and broader innovation activities, and serving as an important member of both the Medical Affairs Leadership Team and the Specimen Management Worldwide Leadership Team.
The incumbent will have past experience with clinical laboratories and also possesses strong leadership and external-facing skills and the ability to be involved in key strategic decisions with the laboratory and other customer segments being at the center of attention. S/he must also have the demonstrated ability to represent Specimen Management with the U.S. Food and Drug Administration (“FDA”) and other regulatory agencies, interacting effectively with their representatives and, where necessary, playing an active role in creating and managing agency expectations. This individual will provide medical, scientific, technical and laboratory customer-focused leadership and perspective and be responsible for ensuring Medical Affairs excellence in clinical study design for clinical studies throughout the BD Specimen Management product life cycle, data analysis and review, as well as for scientific integrity. S/he will also play an important role in resource planning within Specimen Management Medical Affairs by managing resourcing of Medical Affairs participation in product development and lifecycle management and will be accountable for executing the clinical development activities to support product submission to the U.S. Food and Drug Administration (“FDA”) and other regulatory bodies such as, CNDA, EU Notified Bodies. A key financial impact of this position is the timely completion of all Medical Affairs FDA-related deliverables, including clinical test plans for pre-submission and safety and efficacy clinical study data for successful 510k clearance.
The Global Director, Medical Affairs, Specimen Management will have between 3-5 direct reports including Medical Affairs Associate Managers who are overseeing a range of activities across the Specimen Management Platforms and Projects. This role will require extensive cross functional collaborative interaction with BD functions/associates including Business and Marketing leadership, Core Team Leaders and other roles within BD’s Program Management Office, Specimen Management Regional Medical Affairs leaders, Regulatory Affairs, Quality, Research and Development. A critical responsibility of this role will include the development and maintenance of relationships with external entities such as Key Opinion Leaders (“KOLs”) in Laboratory Medicine, professional societies, and other technology companies.
Additional key responsibilities and duties will include, but not necessarily be limited to, the following:
Strategic Orientation: As a member of the Specimen Management Leadership Team, contribute to the development of Specimen Management strategies.
Regulatory and Quality: Responsibility for supporting FDA-related priorities, such as clinical studies and risk assessment, and timely completion of Situation Analysis, Health Hazard Evaluations and NCMRS. Have responsibility for the safety and efficacy of all products and services offered by Specimen Management, including for the conduct of all health risk assessments within Specimen Management and for recommending field actions in case of product issues, MDR reportability and Clinical Evaluation Reports for medical devices. If applicable, impact on quality: Work with Quality and Regulatory Compliance to assess the impact of product issues on patient’s health. Manage Medical Affairs related FDA-Projects: Have oversight accountability of all Medical Affairs FDA work streams; ensure completion of deliverables per agreed upon timelines, Post-Market Surveillance – MA deliverables.
Clinical Development: Leading current clinical study initiatives, design, and conduct to align existing products with current/new FDA regulatory requirements. Have responsibility for the design of clinical studies throughout the BD Specimen Management product life cycle, data analysis and review and approval of study protocols and reports. Have responsibility for Medical Affairs excellence in clinical study design and the review and approval of all Specimen Management clinical study protocols and reports. Lead development of department Standard Operating Procedures (“SOPs”) and lead Medical Affairs work streams to support compliance of BD Specimen Management products to new EU MDR/IVDR regulations. Manage internal clinical studies conducted in Specimen Management Medical Affairs Clinical Laboratory and outside locations for Specimen Management.; have responsibility for the management and execution of the Specimen Management post-market study activities.
Have responsibility for providing medical expertise for timely completion of Situation Analysis, Health Hazard Evaluations and NCMRS. Conduct Medical Device Reportability assessments for all BD Specimen Management products and have responsibility for review and approval of Clinical Evaluation Reports for medical devices.
Responsible for managing the budgets of Specimen Management Medical Affairs Department and clinical trial budgets
Represent Medical Affairs on the Specimen Management Leadership Team.
Experience / Qualifications:
Post-graduate university degree (Masters, PhD, MD); a license to practice medicine will be a plus.
Minimum of 8 years in a management role in a medical device/IVD/MedTech company required; direct management experience required
Strong competency in the areas of clinical laboratory medicine, clinical study design, statistics, technical writing, clinical laboratory operations, clinical diagnostic testing and clinical pathology is essential; knowledge of the preanalytical phase of the total testing process will be a plus.
Deep understanding of clinical laboratory operations and workflow, how they are run and key challenges is essential.
Ability to work collaboratively with BD’s Regulatory Affairs organization, with other functions and externally is critical.
Direct experience working with the FDA and other regulatory agencies is highly desirable; including playing a key role in creating and managing agency expectations.
Goal oriented and disciplined; action oriented and capable of assessing competitive strategies / products and technologically comfortable with the marketplace and the customer.
Ability to develop short- and long-range plans; willingness to develop close working relationships with clinicians, end-users and customers.
Ability to deliver results against a timeline with specified milestones.
Excellent interpersonal skills and demonstrated strong customer/client orientation skills.
A leader of technical personnel possessing superior organizational skills, a strategic and hands-on approach, critical strategic thinking skills and the ability to build effective trusting relationships.
Demonstrated capability for strategic thinking, excellent analytical and problem-solving skills.
Ability to work with teams in a matrix organization and to provide leadership within the medical community.
Ability to integrate medical, scientific, and technical information and effectively communicate data to Regulatory bodies, the scientific community, customers, as well as throughout the organization.
Ability to build, develop and maintain strong relationships with KOLs and other external thought leaders.
Excellent organizational and project management skills; attention to detail.
Demonstrated ability to understand, interpret and explain complex clinical and scientific information.
Strong communication skills (verbal, presentation, written).
Office-based position. Expectation of at least 3 days in-office per work week. Office location is 1 Becton Drive, Franklin Lakes, NJ.
The salary, bonus, and stock option package will be very attractive and competitive with prevailing market standards.
Primary Work Location
USA NJ - Franklin Lakes
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.