BD (Becton, Dickinson and Company) Director, Medical Affairs BDTI in Franklin Lakes, New Jersey
Job Description Summary
Reporting directly to the Vice President of Medical Affairs for the North America Region and BDTI, the Director of Medical Affairs has the responsibility to support the Medical Affairs needs for BD Technologies and Innovation.
BD Technologies and Innovation develops next-generation technologies aligned with BD business strategies. This role will involve the establishment of medical, scientific and technical expertise for the BDTI across its different functional areas. This individual will be a member of the BDTI Leadership Team and serve as a key member of the broader Medical Affairs community. More specifically, the role will involve contributions to broad strategy, and how BDTI contributes to early innovation projects across BD’s segments and business units, participating in the execution and implementation of BDTI bench, animal and human subject research, the safe implementation of protocols, and contributing to BDTI regulatory communications and medical disclosures/publications.
In this role, the Director, Medical Affairs will partner closely with BDTI functional leaders to work with leadership in BD’s segments, business units, central Medical Affairs functions to align and prioritize project work.
The Director, Medical Affairs will need to have a strong medical training and experience with some knowledge of clinical trial strategy, design and execution, and the field of life science academic research.
Contribute to development of BDTI portfolio research strategy.
Work with the Vice President of Medical Affairs for the North America Region and BDTI to determine Medical Affairs engagement and contribution to BDTI research strategy.
Ensures appropriate communication and engagement with BD segment, business units and central Medical Affairs stakeholders and leadership.
Will take a key contributing role in certain high profile BDTI projects (e.g. subject matter expertise contribution for a given project, key liaison for external stakeholder engagement).
Oversees consultation and engagement with Global Clinical Development (GCD) stakeholders to ensure appropriate clinical trial designs and conduct for both new and existing product development.
Potential Clinical Monitor assignment for certain BDTI clinical trials.
Reviews and approves BDTI clinical trial protocols.
Reviews and approves all BDTI generated medical disclosures (e.g. congress presentations and publications).
Contributes to the safe implementation of all in-house BDTI bench and animal work.
Reviews regulatory communications for key BDTI project work.
Ensures appropriate medical and scientific input to the BDTI project teams for key projects.
Participates in all major strategic planning sessions with BD R&D segment and business unit meetings and ongoing discussions.
Builds effective connections, interactions and collaborations with key BD internal stakeholders in R&D, business units and central Medical Affairs.
Helps facilitate engagement with key subject matter experts within the medical and scientific community.
Participate in key external events that help raise engagement and understanding in certain disease state and/or therapeutic areas. This could involve participation in regulatory body events, major congresses and educational events. Participate in the planning and development of key subject matter expert advisory boards.
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) with a strong a background in clinical or scientific investigation.
5 years’ experience in the Medical device/Bio-pharmaceutical industry or clinical research strongly preferred. Experience in both Medical Device and Bio-pharma a significant plus.
Global exposure and understanding of medical/clinical 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.
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.
Demonstrated ability to work within a cross-functional team environment.
Ability to critically analyze material for external use, utilizing clinical experience and understanding of the scientific literature.
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 Medical Affairs 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 clinical and 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.
This position may require some U.S., Canada and international travel.
Must be able to speak and write English fluently. Must be able to communicate clearly and accurately. Multiple languages is a plus.
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.
Management/business experience required to include talent management and budget accountability.
Primary Work Location
USA NC - Research Triangle Park
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.