BD (Becton, Dickinson and Company) Vice President, Medical Affairs, SPECIMEN MANAGEMENT in Baltimore, Maryland
Job Description Summary
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 SMsion 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:
Medical: Improving medication management across the continuum of care; leading in infection prevention and health care safety
Life Sciences: Enhancing the diagnosis of infectious disease and cancer; empowering research insights inside and outside the cell
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 Business Segment / 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 is within the Integrated Diagnostic Solutions Business Unit within BD Life Sciences segment and 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.
The BD Life Sciences - Specimen Management’s full range of products includes:
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 Vacutainer® blood collection tubes.
BD Critical Care Collection syringes including safety products for arterial blood collection and analysis.
A range of Molecular Diagnostic and biomarker products.
Role / Responsibilities:
Reporting to the Worldwide Vice President, Medical Affairs, BD Integrated Diagnostic Solutions (IDS), the Medical Affairs Vice President, Product Development and Lifecycle Management will play an important role in influencing key business decisions within SM Medical Affairs, leading innovation initiatives, overseeing Medical Affairs participation in product development, and serving as a member of the Worldwide SM Medical Affairs Leadership Team. The incumbent will be an experienced clinical laboratorian who also possesses strong leadership and external-facing skills and the ability to be involved in key strategic decisions with the laboratory being at the center of attention. S/he must also have the demonstrated ability to represent SM with the U.S. Food and Drug Administration (“FDA”), interacting effectively with Agency representatives and, where necessary, playing an active role in creating and managing FDA 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 SM 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 SM 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 MDR/IVDR. 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 Medical Affairs Vice President, Product Development and Lifecycle Management, SM, will have between 4-6 five direct reports including Medical Affairs Managers who are overseeing a range of activities across the Specimen Management Business Lines. This role will require extensive cross functional collaborative interaction with BD functions/associates including Core Team Leaders, SM Regional Medical Affairs leaders, Regulatory Affairs, Quality, and 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 representative key responsibilities and duties will include, but not necessarily be limited to, the following:
Strategic Orientation: Responsibility for supporting FDA-related priorities, such as clinical studies and risk assessment, and timely completion of Situation Analysis, Health Hazard Evaluations and NCMRS. As part of the SM Medical Affairs Leadership Team, contribute to the development of SM Medical Affairs strategy.
Leading current clinical study initiatives to align existing products with current/new FDA regulatory requirements
Manage Medical Affairs Manager 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.
Have responsibility for the design of clinical studies throughout the BD SM product life cycle, data analysis and review and approval of study protocols and reports.
Have responsibility for the safety and efficacy of all products and services offered by SM, including for the conduct of all health risk assessments within SM 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 impact of product issues on patient’s health.
Have responsibility for Medical Affairs excellence in clinical study design and the review and approval of all SM clinical study protocols and reports. Lead development of department Standard Operating Procedures (“SOPs”) and lead Medical Affairs work streams to support compliance of BD SM products to new EU MDR/IVDR regulations. Manage internal clinical studies conducted in SM Medical Affairs Clinical Laboratory and outside locations for SM.; have responsibility for the management and execution of the SM post-market study portfolio.
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 SM products and have responsibility for review and approval of Clinical Evaluation Reports for medical devices.
Responsible for managing the budgets of SM Medical Affairs Department and clinical trial budgets
Represent Medical Affairs on the SM Leadership Team.
Experience / Qualifications:
University degree in medicine (M.D.) with specialty training in clinical pathology is required; a license to practice medicine will be a plus.
Minimum of five (5) years of practice in a field of clinical pathology is required; minimum of 5-10 years in a leadership role in a medical device/IVD 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 what a laboratory is and how it is run, is essential.
Proven clinical pathology expertise and understanding of clinical study design and management.
Ability to work collaboratively with the Company’s Global Development teams and to serve as the Medical Affairs SM strategist in getting clinical studies moving is critical.
Ability to work collaboratively with the Company’s Regulatory Affairs organization.
Direct experience working with the FDA is critical; skills required to play a key role in creating and managing FDA expectations is highly desired.
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.
A track record of peer-reviewed publications.
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 leadership skills are required; prior management experience is strongly desired.
Demonstrated capability for strategic thinking, excellent analytical and problem-solving skills.
Ability to work with teams 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).
Bench International will identify, screen and conduct initial telephone interviews with all potential candidates with the objective of ascertaining whether or not individuals meet the search criteria. As candidates are deemed appropriate, Bench may arrange for each candidate to participate in completing an assessment tool, specifically designed to predict impact and success in this particular role. Confidential face-to-face meetings will also be scheduled with the candidate and a Bench International representative. The significant other/partner/spouse of the candidate will generally be asked to participate in the process in order to identify professional, educational and/or other relocation issues that would need to be addressed in the event of relocation. Prior to our Client extending an offer, Bench will conduct 360° references and will require verification of the proposed incumbent candidate’s credentials. Depending on the Client's instructions and/or the nature of the position, Bench may also require that the proposed incumbent provide Bench with a signed release authorizing Bench to conduct a background check. Our Client and Bench are dedicated to making this transition viable for the right candidate and all parties concerned.
The salary, bonus and stock option package will be very attractive and highly competitive with prevailing market standards.
Primary Work Location
USA MD - Sparks - 7 Loveton Circle
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.