BD (Becton, Dickinson and Company) Sr Director Medical Affairs-Physician in Warwick, Rhode Island
Job Description Summary
Reporting directly to the business unit Vice President of Medical Affairs, the Sr Director of Medical Affairs provides strategic and medical/scientific leadership for or the Business Unit. The position has overall responsibility for the safety and efficacy of all products within the business unit. The role ensures strategic and operational excellence of the Medical Affairs function and its members for this business unit.
Reporting directly to the business unit Vice President of Medical Affairs , the Sr Director of Medical Affairs provides strategic and medical/scientific leadership for or the Business Unit. The position has overall responsibility for the safety and efficacy of all products within the business unit. The role ensures strategic and operational excellence of the Medical Affairs function and its members for this business unit. This individual will be responsible, along with Vice President for Medical Affairs, for management of the team of Medical Affairs professionals who contribute to product ideation, concept development, product validation and qualification, legal and regulatory compliance, clinical evidence generation, demonstration of product value, stakeholder education and risk/benefit assessments throughout the product life cycle.
The Sr. Director of 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 Regulatory Affairs, R&D, Strategic Marketing, and Business Development to foster innovation within the Business Unit.
Works with the Vice President of Medical Affairs and the Business Unit Leadership to determine strategy for new product development, prioritization of projects and resource management for the business.
Working in close cooperation with Regulatory Affairs and other functions, ensures that appropriate Evidence Generation Plans are in place for all products on the market and in development
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 Affairs (GCA) to ensure appropriate clinical trial designs for both new and existing product development. While GCA is responsible for study protocol development and study execution, BU MA ensures proper study design, analysis, interpretation, and publication / presentation of study results to maximize value to the business.
Determines whether there exist any adverse health consequences for any products that the business manufactures both during development and when marketed, through formal Risk Assessment procedures (FMEAs, SAs, HHEs, etc.) in cooperation with the Global Medical Safety team.
Provides guidance to MA staff in the WW Business to ensure success in clinical trials for product registration and determination of safety and efficacy for marketed products.
Provides senior-level clinical expertise in submissions and communication with FDA and other Regulatory authorities around the world.
Builds effective connections, interactions and collaborations with clinical investigators and Key Opinion Leaders (KOLs) at a peer-to-peer level, worldwide.
Represents BU 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 the BU’s product portfolio
Medical Degree (M.D., D.O. or equivalent) and with at least 5 years of clinical experience in one of the surgical disciplines, including experience in clinical investigation.
Three or more years’ experience in the Medical device/Bio-pharmaceutical industry strongly preferred. Experience in both Medical Device and Bio-pharma a significant plus.
MBA, MMM, MPH, MHA degree granted or in progress desirable
Global exposure and understanding of medical/surgical practice
Must have clinical knowledge obtained through medical education and medical practice. Needs 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.
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 frequently, 35%: U.S., Canada and international.
Must be able to speak and write English fluently; must be able to communicate clearly and accurately.
Must be able to understand legally and technically written standards, regulations, procedures, test methods so as to communicate their intent.
Demonstrated record of peer-reviewed publications and a regional or national reputation in the relevant medical field to the BU. Ability to qualify for at least Assistant professorship at an academic medical school and attending privileges at an academic teaching hospital desired.
Management/business experience required to include talent management and budget accountability.
Experience in pre-clinical research including experience in development and execution of pre-clinical models used for medical device development and evaluation is desirable. Knowledge of GLP standards and regulations desirable
Internal Relationships: Management Board, Regulatory Affairs, Quality Assurance, Research & Development, Operations, Manufacturing Engineering, Sales, Marketing and Business Development and Finance
External Relationships: Corporate Medical Affairs, Corporate Regulatory Affairs, Corporate Legal Department, International Medical Directors, FDA, Notified Bodies, Global Clinical Development, Industry Trade Organizations
Scope and Impact of Position:
Failure to anticipate and respond appropriately to external influences of FDA, other government/regulatory agencies, and Customers can adversely affect patient care and the Company’s ability to meet business objectives.
Primary Work Location
USA RI - Warwick
USA IL - Vernon Hills
NA (United States of America)
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.