BD (Becton, Dickinson and Company) Sr Director, Medical Affairs - MD in San Diego, California
Job Description Summary
Reporting directly to the Medication Management Solutions (MMS) business unit WW Vice President of Medical Affairs, this role has the responsibility to support the WW VP, Medical Affairs in providing medical, scientific and technical customer-focused leadership and strategic perspectives across the business unit, as well as acting as the lead medical expert where assigned.
The position will help drive the safety and efficacy of all products within the business unit. The role helps ensure the 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 of 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, demonstration of product value, stakeholder education and risk/benefit assessments throughout the product life cycle.
In this role, the Director will partner closely with worldwide business teams as well as regional leadership and the central Medical Affairs Function to align prioritized product, educational and clinical plans to support BD’s value-based strategy. S/he will oversee the development, update and implementation of the MA Policies and Standard Operating Procedures to optimize MA functioning in terms of leadership, compliance and productivity.
Where assigned, the Director will be responsible for establishing and updating the Integrated Medical Plans and driving the clinical development and evidence generation plans as well as publication and scientific exchange plans to contribute to product development, meet regulatory requirements and support appropriate use. 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 the Business Unit.
As a member of the Medical Affairs Leadership Team (LT) for MMS, the Medical Director, Medical Affairs is responsible for supporting medical risk and safety assessments, new product development, US and international regulatory needs and other medical/clinical activities in support of the Business Unit e.g. evidence generation, scientific relationships with key opinion leaders (KOLs); and advisory board meetings.
Responsibilities will include, but are not limited to, the following:
Participate in risk assessment activities
Participate as needed as part of the crisis-management teams for marketed products, i.e. in case of field corrective actions, recalls, ship holds.
Provide clinical and scientific support in responding to inquiries from healthcare professionals and organizations.
Continuously develop knowledge of regulatory, pharmacovigilance and quality assurance requirements in alignment with BD Practice Standards.
Reviews Clinical Evaluation Reports (CER), R&D, Regulatory and Quality documentation as needed as part of regulatory submissions, compliance and remediation activities
Ensure support for activities in clinical development by collaborating with the clinical operations teams.
Support appropriate strategic go-to-market models with business group and commercial teams.
Direct the identification and development of KOLs across different therapy areas as needed, investigate new uses of BD’s products, and ensure collaboration with appropriate scientific societies.
Demonstrate ability to identify unmet clinical needs, evaluate product opportunities from a clinical perspective, and help develop strategies that leads to efficient development of such opportunities.
Partner with Business Development for evaluating licensing, partnership or acquisition opportunities.
Provide scientific input into evidence generation and publication strategy and review manuscripts for publication and abstracts and posters for presentation at scientific meetings
Collaborate with Commercial, Legal, and Regulatory for development and review of labeling, advertising and promotional materials
Ensure relevant and appropriate responses to customer inquiries for relevant BD products.
Continuously maintain “state of the art” level of knowledge for the entire global medical team as to developments and trends in medical science relevant to the business.
Participate in the investigator initiated research review and educational grant process approvals.
Education & Experience:
M.D. with critical care or anesthesiology training or internal medicine and other specialties with significant experience with acute care, emergency and critical care environment.
A minimum of 5+ years Industry experience in Medical Affairs within the biotech/medical device industry is preferred
Experience with infusion pumps and other medication error reducing technologies a plus
Experience with clinical informatics and data analytics a plus
Strong knowledge and respect of FDA / EU/ ICH regulations and guidelines, and applicable international regulatory requirements a plus
Must have clinical knowledge obtained through medical education and medical practice. Reasonable knowledge of clinical trial design, statistics, and data analysis.
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.
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.
Must be able to organize, prioritize and work effectively in a constantly changing environment
Availability to participate in early or late meetings/teleconferences
Ability and willingness to travel 20% of time as needed.
Position based in San Diego or Southern CA.
Primary Work LocationUSA CA - San Diego TC Bldg C&D
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.