BD (Becton, Dickinson and Company) VP, Global Medical Affairs - Pharmaceutical Systems in Le Pont, France
Job Description Summary
Reporting directly to the Chief Medical Officer, and with a strong dotted line to the WW President, Pharmaceutical Systems (PS), the VP Global Medical Affairs provides strategic and medical/scientific leadership for BD PS, worldwide. The position has overall responsibility for the safety and efficacy of all products within the business. The role ensures strategic and operational excellence of the Medical Affairs function and its members on a global basis for this business unit. This individual will be responsible for, and management of the team of Medical Affairs professionals who contribute to product ideation, concept development, product validation and qualification, legal and regulatory compliance, demonstration of product value, stakeholder education and risk/benefit assessments throughout the product life cycle.
The VP, Global Medical Affairs is a member of the WW Pharmaceutical Systems Leadership Team (PS LT), the Pharmaceutical Systems Portfolio Decision Team (PS PDT), and the BDX Medical Affairs Leadership Team (MALT).
The VP, Global Medical Affairs needs to have strong strategic and operational experience with clinical trial strategy, design and execution, demonstrated productivity in peer-reviewed publication and public speaking/presentation, as well as external KOL engagement. It is also very important for this leader to be a proactive contributor to the business by working closely with R&D, Strategic Marketing, and Business Development to foster innovation within Pharmaceutical Systems.
As a member of the WW PS LT, contributes to development of overall worldwide business strategy.
Works with the PS LT to determine strategy for new product development, prioritization of projects and resource management for the business.
Ensures understanding and support of PS WW strategy by all MA associates.
As a member of the WW PS LT and MALT, may lead Business Unit or BDX Medical Affairs KDGs (Key Driver Goals).
Leads MA activities of innovation and new product development to include concept ideation, interaction with cross functional development teams, and assessment of clinical evidence requirements to meet regulatory, safety and efficacy criteria.
Oversees consultation with associates from Global Clinical Development (GCD) to ensure appropriate clinical trial designs for both new and existing product development. While GCD is responsible for study protocol development and study execution, PS MA ensures proper study design, analysis, interpretation, and publication / presentation of study results to maximize value to the business.
Reviews and approves proposals for IIS (Investigator-Initiated Studies).
Determination of the safety and efficacy of both new and existing products for PS. Reviews all regulatory submissions to ensure adequacy of support for all claims pertaining to the safety, effectiveness, and clinical performance of all products.
Determining whether there exist any adverse health consequences for any products that PS manufactures both during development and when marketed, through formal Risk Assessment procedures (FMEAs, SAs, HHEs, etc.).
Provides guidance to MA staff in all worldwide PS businesses/regions to ensure success in clinical trials for product registration and determination of safety and efficacy for marketed products.
Ensures appropriate input to the product teams for determining the potential clinical utility of any product under development by the Unit.
Works in close association with the VP of R&D and any research or other PS business groups involved with the exploration of potential new technologies for both core and OTHC (Outside the Home Court) products/services.
Provides senior-level clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world.
Ensures MA support to the worldwide Sales and Marketing departments.
Builds effective connections, interactions and collaborations with clinical investigators and Key Opinion Leaders (KOLs) at a peer-to-peer level, worldwide.
Represents BD PS MA to professional societies and at medical and scientific meetings and seminars, often by invitation.
Keeps abreast of trends in health care delivery, diagnosis and treatment of human disease, especially as these relate to diabetes.
Experience and Education:
Actively licensed physician with a Medical Degree (M.D., D.O. or equivalent) and with at least 8-10 years of experience in clinical medicine, including significant capability in clinical investigation. Seven or more years’ experience in the Medical device/bio-pharmaceutical industry strongly preferred.
Prefer demonstrated record of peer-reviewed publications and a regional or national reputation in the industry. Ability to qualify for at least Assistant professorship at an academic medical school, and attending privileges at an academic teaching hospital highly desired.
Management/business experience desired to include talent management and budget accountability.
Strong preference to those who are Board-certified in a related medical specialization.
Global exposure and understanding of medical/clinical practice and medical industry practices.
Knowledge, Skills, and Abilities:
Must have clinical knowledge obtained through medical education and medical practice. Needs significant knowledge of clinical trial design, statistics, and data analysis. Should have an understanding of Good Clinical Practices (GCP) and FDA requirements for clinical investigation.
Influencing Skills - Able to establish rapport, value and respect within a complex and highly technical environment internally, as well as with KOLs and other influential stakeholders, externally. Able to influence directly and indirectly. Able to initiate and effectively lead change efforts.
Interpersonal Skills - Able to establish and build close working relationships across a highly matrixed organization and with alliance partners. Strong personal credibility, written and oral communication skills. Accomplished in group, business and social settings, respected by professional peers. Comfortable and capable in a variety of cultures and skilled in working internationally.
Business Acumen – Able to demonstrate business acumen and maturity within a strong group in order to effectively manage internal and external relationships and gain credibility in the role.
Leadership Skills - Team oriented with the confidence, maturity and integrity to lead effectively. Self-directed with strong initiative; leads by example. Able to demonstrate the key capabilities of the BD Leadership Standard.
Results and Action Oriented - Driven to excel and capable of inspiring others to excellence as well. Able to envision a winning future for the organization and help turn that vision into reality through strategic planning plus hands-on action. Accepts accountability for results of the MA team and provides clear direction with input from others.
Problem Solving Skills – Brings a high level of intellect and curiosity to work. Able to apply mature business judgment in making decisions. Creatively and effectively challenges the thinking of others. Capable and effective in negotiations. Able to see the cultural and personal implications of decisions and plan for them.
Willing to travel 15%.
Primary Work Location
FRA Le Pont-de-Claix Cedex
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.