BD (Becton, Dickinson and Company) Vice President - Medical Affairs in Covington, Georgia
Job ID: 2018-12351
Career Level: experienced
Location: Covington,Georgia,United States
The Vice President - Medical Affairs for UCC is a Management Board level position reporting directly to the World Wide President for UCC, and will be based in Covington, GA. He/She will maintain overall responsibility for establishing and managing all activities in Medical Affairs for the BU. This individual will develop and deliver innovative integrated Medical Affairs programs and activities, and will lead liaisons and interactions with Research & Development (“R&D”) within the BU and the external scientific community with a focus on innovative new product and service ideas. The incumbent will also have the requisite experience and capabilities required to expand the breadth of this role to include driving and building robust evidence generation programs for the BU, leveraging or building capabilities for success in Evidence Generation, and guiding programs across the continuum of evidence needs (e.g., regulatory, clinical trials, post marketing studies, HE/OR, reimbursement).
Summary of Position with General Responsibilities:
Internally, this position provides medical leadership in the following strategic roles:
Ensures all UCC products are meeting the regulatory requirements, that appropriate risk assessments are conducted relative to complaints, and to ensure successful new product commercialization
Provide medical and scientific guidance and consultation to regulatory affairs staff for the development and implementation of regulatory approval strategies
Provide medical and scientific guidance and consultation to quality staff for the clinical assessment and resolution of product risks
Developing clinical strategies including spearheading the design of clinical trials and working with Clinical Sciences to develop publication and presentation strategies,
Ensuring the effective development and adoption of UCC products to fulfill customer needs including working with platform teams to define technology requirements, provide user input and feedback and optimize global physician education, and
Monitoring products for post market safety.
Essential job Functions:
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Please note, other duties may be assigned as needed:
Ensure strong Thought Leader relationships; develop and nurture relationships with Key Opinion Leaders and consultants in the clinical community in order to strengthen UCC’s leadership position; serve as a professional representative of the BU in the healthcare community.
Provide effective Medical and Scientific field based support.
Ensure safety and efficacy of BU products.
Provide critical input into the identification of new product opportunities and strategic direction of the BU.
Share responsibility as part of the UCC Leadership Team for decisions regarding the development portfolio, new business opportunities and strategies for product development, registration, and commercialization.
Play a key role in enabling the Medical Affairs organization to become a greater driving force in shaping the future strategic direction of the BU.
Bridge the interfaces between the core product development teams and the clinical environment and serve as an influential leader in helping the BU to identify clinical trends, unmet medical needs, and new innovative technologies which support the BU strategy.
Seek opportunities to introduce and expand UCC’s position and influence in the health care environment through appropriate targeted activities with key customers and selective affiliations with key professional organizations.
Accountability for review and approval of requests for educational grants, scientific information and investigator-initiated research grants.
Provide technical leadership and vision by uncovering emerging clinical trends and projecting their relevancy to UCC via specific product line adjustments.
Provide medical and scientific expertise of potential acquisitions as well as any licensing or other business development opportunities. The successful candidate must possess a strategic mind, able to visualize a potential beyond the current product line and/or existing medical practices.
Provides expert advice on the design and content of promotional materials including the review and clearance of these materials.
The requirements listed below are representative of the knowledge, skill, and/ or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
M.D. degree is required; additional advanced degree (MBA, MHA or MPH) would be an asset.
A minimum of 8- 10 years' prior industry experience, which shall include experience leading a Global Medical Affairs organization and a clear understanding of the integration of Medical Affairs activities into the commercial environment within the global marketplace, and new product development experience including understanding of applicable regulatory and ISO standards.
Ability to view Medical Affairs from both a medical as well as a business perspective; to engage heavily with the commercial organization and maintain strong and collaborative relationships within the BU.
Ability to strengthen the development of product value proposition by integrating Evidence Generation & Market Access Strategies, and to focus on customers’ needs, especially payers, across the product lifecycle.
Experience providing medical / clinical input at the working group level from the early concept stage through lifecycle management, which includes the safety / efficacy assurance role.
Knowledge of Regulatory guidelines related to Medical Research, Education and Communication.
Accomplishments in successfully leading medium to large-sized organizations of healthcare professionals, and in interfacing with corporate leadership and leverage shared resources/Centers of Excellence.
Demonstrated ability to speak in public forums of varying size and audiences.
Demonstrated budgetary and clinical research experience.
Great passion for patient and customer needs.
Understanding of compliance issues coupled with the ability to translate experience in compliance area to others.
Excellent people management skills; strong leadership orientation with the ability to influence; excellent interpersonal skills particularly in working in a highly matrixed organization.
Proven ability to successfully network with subject matter experts.
High level of energy and demonstrated history of having worked in a fast-paced, evolving global environment.
Excellent clinical judgment, strong organizational abilities, high credibility and significant leadership potential.
Strong strategic business acumen coupled with global medical outlook focused on unique approaches to solving unmet medical needs and identifying “white space” opportunities.
History of success in establishing and maintaining beneficial relationships with Key Opinion Leaders.
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.
Generally, written rules, precedents and policies to determine or guide decisions are existing and accessible. Judgment calls will be made by this individual based on experience, education, and all available facts, since each project is unique. The individual must be able to initiate learning and decision-making without much initial information.
Employee may be required to sit, bend, stoop, use keyboard, see, talk, hear, and walk and stand on concrete surface for extended periods. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This individual generally will work in an office environment with moderate noise and traffic.
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