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Immediate Job Opportunity
Senior Director, Medical Affairs
Abbott Rapid Diagnostics, Consumer Services & Products Business
DO WORK THAT MATTERS
At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
We have an exciting opportunity for a Senior Director, Medical Affairs within our Abbott Rapid Diagnostics (ARDx) Division. This newly created position is part of the ARDx Consumer Services & Products (CSP) Business Unit, reporting into the Division Vice President, CSP BU. The primary focus will be on supporting the Acelis Connected Health (ACH) business, which comprises PST-INR testing for warfarin remote patient monitoring (RPM) and Ventricular Assist Device (VAD) supplies/services; but may require support for other CSP businesses and innovation planning cycles. This individual will align with the global Clinical, Scientific & Medical Affairs function for the ARDx Division to set our CSP Medical Affairs Strategy to achieve clinical outcomes improvements for our patients and support future market access expansion efforts. The optimal candidate will lead the Medical Affairs function of the CSP Business Unit and play a key role in contributing to the innovation road map to drive the R&D pipeline for business growth and commercial success.
As a strategic thought leader and expert in Cardiometabolic Diseases, you will assist in assessing emerging and/or unmet medical needs in remote patient monitoring, evaluate opportunities for product improvements, and contribute towards development of disruptive new technologies. You will lead KOL advocacy efforts and manage Scientific Advisory Boards designed to secure feedback to shape our clinical & commercial strategies. You will provide guidance on designs for pre- and post-market clinical studies aimed to demonstrate value propositions through clinical and economic outcomes measures. Responsibilities also include providing essential medical input into product performance, risk management and collaboration with other key functions, including Global Marketing, R&D, and Regulatory Affairs. You will serve as the key medical representative of the CSP BU to external regulatory agencies, professional organizations, scientific advisory boards and key clients. You will also provide medical support for direct interactions with large customers and insurers/payers (including CMS) as needed. This position can be remotely based near a large airport and will require ~50% travel, assuming ongoing KOL/customer visits, attending key medical congresses, 1-2 Advisory Boards/year, and 1 week/quarter attending meetings at an Abbott facility (normally ARDx division HQ in Lake Forest, IL or ACH HQ in Livermore, CA).
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
Build and improve Medical Affairs functional capabilities, implement process and procedure to serve business compliantly (to ARDx quality system), effectively and efficiently.
Work with Scientific Affairs, R&D and Clinical Affairs to assess emerging and/or unmet medical needs.
Work with R&D functions to identify and evaluate markers for new disease areas or product improvements; technologies and intellectual properties.
Provide strategic direction for completion of medical opinions, medical platform documents and/or Health Hazard Assessment.
Review and provide medical input for promotional and commercial activities as requested. Provide strategic guidance for the performance of clinical studies related to product development and commercial/marketing activities.
Serve as the key medical representative of Acelis Connected Health (ACH) to external regulatory agencies, professional organizations and key clients.
Serve as Medical Director and supervising physician for the Company’s Medicare anticoagulation monitoring IDTF (Independent Diagnostic Testing Facility) enrollment, including short- and long-range strategic planning for the IDTF. Maintain a license to practice medicine to provide clinical oversight as a supervising physician for ACH’s IDTF operation of INR warfarin testing RPM services.
Provide direct and ongoing oversight of the quality of testing performed, the proper operation and calibration of equipment, the qualifications of non-physician personnel, and execution of any required supervising physician attestation statements.
Assist in developing, periodically reviewing, and revising policies and procedures related to the provision of test materials and subsequent collection and reporting of test results to the patient’s treating physician; training of new patients in the proper use, care, and calibration of home INR monitoring equipment; and qualifications, selection, hiring, retention, training, and ongoing performance evaluation of technicians, clinicians, and other non-physician personnel performing clinical activities on behalf of the IDTF.
Provide general supervision at the IDTF site to address urgent or emergent questions about test results or other medical aspects of the IDTF’s operations, including medical and scientific support for direct customer interactions as needed.
Participate in the development and implementation of quality assurance and quality control program activities at the IDTF site, including routine meetings with Acelis’ compliance/regulatory personnel regarding the medical aspects of the IDTF’s operations.
Assist ACH in complying with all state and federal laws, as well as accrediting organization requirements, concerning medical standards at the IDTF.
Review sample test results to ensure collection and reporting practices are consistent with Acelis’ policies and procedures, and report to management on all medical aspects of the IDTF’s operations.
As requested, provide education and in-service instruction programs for the IDTF’s non-physician personnel.
As appropriate, assist in reviewing and resolving complaints or concerns from patients, caregivers, or physicians regarding the testing services provided by Acelis.
Perform such other duties as may from time to time be required by Acelis, which duties are reasonably related to the medical aspects of the IDTF’s operations.
Must comply with and enforce all Abbott’s Office of Ethics and Compliance guidelines.
◦ MD Degree with clinical experience including Cardiometabolic Diseases; active license to practice medicine to support the IDTF operation as the supervising physician
◦ Minimum 5 years clinical experience and 5 years industry experience
◦ Knowledge of regulations and standards affecting Cardiovascular Disease, Population Health and Remote Monitoring
◦ Industry and health plan/health system customer knowledge required.
◦ Proven leader with passion and skills for strategic and critical thinking, problem solving, motivating and mentoring team members.
◦ Health plan and accountable care-based health system experience
◦ MBA desirable
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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