Senior Director, Medical Affairs

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

The Opportunity

We are seeking a highly experienced and strategic Senior Director of Medical Affairs to lead medical and scientific initiatives across our Structural Heart Valve Therapy platform, including TAVI, TMTI, and Cardiac Surgery. This role is critical in shaping clinical development strategies, guiding regulatory submissions, and supporting cross-functional teams to ensure the safe and effective use of our products.

What You'll Work On

• Serve as a subject matter expert in structural heart valve therapies, maintaining current knowledge of standards of care and relevant medical literature to support internal and external inquiries.
• Collaborate with R&D, manufacturing, and quality teams to integrate product lifecycle insights into clinical trials; align clinical strategies with commercial objectives.
• Engage with external Key Opinion Leaders (KOLs) to guide treatment protocols and clinical development.
• Provide medical and scientific leadership in preparing global regulatory submissions and representing the company in regulatory meetings.
• Lead the design and approval of clinical strategies, trial protocols, investigator brochures, and study reports.
• Oversee internal medical monitoring processes, including adverse event reporting and clinical event committees, in partnership with Clinical Affairs and Product Performance.
• Partner with product development and marketing to define clinical requirements and review promotional and training materials for scientific accuracy and compliance.
• Investigate product complaints with clinical impact and support post-market surveillance.
• Author and review internal and external literature, white papers, and Medical Affairs Information responses.
• Ensure compliance with FDA and global regulatory standards, and maintain collaborative communication across teams, customers, and vendors.

Strategic Program Involvement

You will also play a key role in the implementation and expansion of the Structural Heart valve platforms. Your strategic contributions may include:

• Proctoring new U.S. sites and providing ongoing case support.
• Training and supporting U.S. clinical field specialists.
• Participating in proctor meetings, Medical Advisory Boards (MABs), and valve product summits.
• Providing input to R&D, QA, Regulatory Affairs, and Clinical Affairs.
• Engaging with customers on device efficacy, safety, and future product development needs.

Qualifications

• MD required; post-graduate degrees preferred.
• 10+ years as an interventional cardiologist or relevant experience.
• Strong knowledge of cardiovascular anatomy, physiology, pharmacology, and device interactions.
• Experience in medical device development, clinical trial design, and regulatory submissions.
• Skilled in medical monitoring, adverse event reporting, and oversight of clinical events committees.
• Proficient in medical writing and review of promotional, training, and scientific materials.
• Ability to assess product complaints and contribute to post-market surveillance.
• Collaborative experience in matrixed, cross-functional environments (R&D, Regulatory, Clinical, Marketing).
• Excellent communication, leadership, and multitasking skills in fast-paced settings.

APPLY NOW

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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