Abbott Director Medical Affairs, MCS in Sylmar, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Working independently and under broad guidance from senior management, the incumbent has direct responsibility as a medical expert in support of the Clinical Affairs, Research and Development, Regulatory Affairs, Health Economic Outcomes Research, Quality, and Commercial functions at Abbott. This includes the application of advanced clinical expertise in the incumbent’s medical specialty to support clinical trial activities, new product/technology development, regulatory submissions, and to resolve product issues. Serves as a medical advisor on multiple programs within Abbott that require in-depth medical expertise. Sets goals, ensures they are met, and is responsible for continuous process improvement. Uses best business practices to ensure success in areas of responsibility. Identifies and routinely uses effective, cost efficient, and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Works on complex problems where analysis of situations or data requires an in -depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Ensures budgets, schedules, and product performance requirements are met. Assures that quality of services meets internal and external customer requirements. Supports appropriate use and understanding of Abbott products in clinical practice. Communicates effectively internally with Abbott colleagues and externally with customers, investigators, regulators, and other stakeholders. Remains current on developments in field(s) of expertise.
C lini c al Affairs: As a medical expert, provides guidance in the strategy, design, and execution of clinical trials. Supports training activities that require in-depth clinical and medical knowledge. Provides medical and clinical expertise on the proper usage of Abbott products for clinical trial investigators which may include training in a pre-clinical laboratory setting and/or field proctoring in the clinical setting. Provides medical expertise on adverse events and field issues that develop during the course of a clinical trial. Provides input and supports the preparation and review of clinical protocols, reports, case summaries, and scientific manuscripts.
Research and Development: Collaborates closely with research and development teams to provide clinical guidance for the development of new technology, identifies clinical risks, and proposes potential mitigation during the design phase. Provides guidance in the design and execution of pre-clinical studies utilized to evaluate new technologies.
Regulatory: Reviews and evaluates Clinical Expert Reports (CERs). Provides medical and clinical guidance for complex regulatory submissions. Prepares responses to questions from regulatory agencies that require in-depth clinical and medical knowledge.
Quality: Provides clinical and medical expertise for product issues. Manages the Medical Advisory Board. Provides clinical input for establishing in a systematic manner the clinical severity associated with product defects. Provides clinical guidance in resolving field complaints and product defects.
Marketing: Works collaboratively with Marketing Department leadership to provide medical input for a broad spectrum of marketing activities and projects. Identifies and participates in evaluating product and business development opportunities. Identifies, builds networks, and establishes strong relationships with key opinion leaders in order to inform and advise marketing, research and development, clinical affairs, and quality activities.
Customer/Investigator Relations: Identifies and establishes productive relationships with key opinion leaders, investigators and customers to support the overall business goals of the company.
Fellows Programs: Leads and or participates in the fellows programs for products and portfolios in her or his expertise. Manages or works with a team that creates strategy and executes programs worldwide across these portfolios.
Accessible for consultation as an internal medical expert across Abbott. Remains current on developments in field(s) of expertise, regulatory requirements, and industry trends and trains staff regarding changing regulations that affect Abbott clinical studies. Maintains knowledge of current and pending medical research and regulations by reviewing key literature and trade journals, participating in professional associations, and by attending conferences. Represents Abbott at national professional meetings. Resolves and/or facilitates resolution of problems including identifying causes to prevent their recurrence. Performs related functions and responsibilities, on occasion, as assigned. Travels as needed to support company objectives and attend company meetings and events.
Required Qualifications :
A board-certified M.D degree with post-graduate training in cardiovascular medicine or surgery and with pre-clinical and clinical research experience is required. A minimum of ten plus years of progressively more responsible experience in the execution of pre-clinical and clinical research exemplified through publications within peer-reviewed journals is also required. Demonstrated expert ability to analyze and interpret complex clinical data acquired from various pre-clinical and clinical research activities. Proficient in providing medical guidance on regulatory and clinical affairs issues. Expert ability to evaluate and investigate new medical device technologies. Must have direct clinical familiarity with Abbott products. Seasoned judgment acquired through wide experience and cross-organizational assignments. Ability to work independently with minimal supervision, as well as cooperatively/productively with others. Requires the ability to change the thinking of, or gain acceptance of others in sensitive situations. Requires highly developed leadership skills/people-management experience sufficient to assume the complex range of personnel issues inherent in this position. Must be adept at delegation, follow-up, and team building. Comprehensive verbal and written, analytical/problem solving, communication, negotiation, interpersonal, training and presentation skills are essential. Must be able to understand and be completely familiar with applicable Quality Systems Regulation (QSR)/ISO Standards, Food & Drug Administration (FDA) regulations, and other relevant engineering/regulatory /manufacturing requirements as well as Abbott operating procedures, policies, processes, and tasks. Advanced personal computer skills including spreadsheet, word processing, database management, and specialized applications used in relevant clinical processes, as well as with surgical implant procedures.
Desired Qualifications :
Prior relevant medical device implant and/or device management experience is preferable, along with expert know ledge of relevant organ system anatomy, physiology, pharmacology, and pathology, direct prior and continued current experience in the management of patients with relevant disease states.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com