Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Director, Medical Affairs
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
WHAT YOU'LL DO
We are recruiting for a Senior Director, Medical Affairs to join our global team based at our Santa Clara, CA location. In this role, you will interact with all other functions within the SH Business Unit. This role will also serve as an advisor to the Clinical Science and ISS groups within the department as well as R&D. There will be a high level of involvement with our field clinical teams in both a clinical trial and commercial setting and may include MD to MD proctoring in addition to both internal and external training and education. The role will be predominantly US based but with global responsibilities.
- Provides medical support to the Office of the Chief Medical Officer that includes representing the Division at Medical Conferences and Physician/Hospital interactions.
- Collaborates with the DVP in the translation of programs established by senior management into operational plans and schedules.
- Make appropriate product and procedural recommendations and work closely with doctor/patient related issues for all structural heart products and clinical study activities.
- Work closely with training and education
- Provide medical oversight for on-market product and product performance functions, including monitoring of product safety related items (i.e. complaints, MDRs), reporting, evaluation, and Health Hazard Evaluations and safety in clinical study design.
- Review and evaluate product performance data and trends to provide early identification of issues related to product performance or usage concerns in order to minimize clinical safety risk.
- Work cross functionally with division Compliance, Clinical Science, Regulatory Affairs, Marketing, Quality and Commercial organizations. This includes involvement with all on-market product performance, clinical product performance, compliance, clinical, clinical science, medical information, professional education, scientific, and regulatory groups
- Interact with internal compliance organization, FDA and/or international regulatory bodies, as required, in response to product performance inquiries and clinical study product performance matters, to enhance business growth opportunities for Abbott.
EDUCATION AND EXPERIENCE YOU'LL BRING
- Medical degree
- 8+ years of clinical experience including personal clinical experience, technical skills, and knowledge in the field of transcatheter valve and other structural interventions (eg LAOO)
- Cardiology experience
- Demonstrated experience collaborating with and working with cross-functional teams in a geographically diverse, matrixed organization
- Excellent verbal and written communication skills, with ability to communicate to all levels of the organization and present to executive management, to the board, and/or to the public
- Proficient with MS Office (Excel, Word, PowerPoint, etc)
- Ability to travel internationally (up to 50 %)
- Advanced level degree(s)
- Experience working in a highly regulated and high-quality system environment
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
Medical & Scientific Affairs
SH Structural Heart
United States > Santa Clara : 4551 Great America Parkway
Yes, 75 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: webstorage.abbott.com/common/External/EEO_Spanish.pdf