Medical Director, AI Innovation and Validation, Global Patient Safety

AstraZeneca • New York, NY

98d • $241,613 - $362,420

About The Position

The Medical Director will provide experienced clinical oversight for the design, validation, and implementation of AI-driven solutions within Global Patient Safety. This physician leadership role is critical in guiding AstraZeneca's strategy for employing Artificial Intelligence to transform Patient Safety and especially its direct application to clinical safety, transforming Patient Safety’s strategic contribution to clinical development. You would be responsible for guiding the adoption of AI into all aspects of Patient Safety, demonstrating robust validation of AI tools applied to Patient Safety, and ensuring all AI applications meet the highest standards of medical accuracy, ethical integrity, and regulatory compliance. The role involves shaping the responsible adoption of sophisticated AI, including generative technologies, to enhance pharmacovigilance capabilities such as case processing, safety surveillance, and signal detection as well as clinical assessment of safety cases, case series, and toxicity management and mitigation strategies. Success hinges on deep medical expertise, a thorough understanding of the AI ecosystem in Patient Safety, and strategic collaboration with internal cross-functional partners (including Patient Safety, R&D, IT, Clinical Development, Regulatory Affairs) and proactive engagement with Health Authorities, all to ultimately enhance patient health and safety.

Requirements

• Medical Doctor (MD) or equivalent medical degree.
• Board certification in a relevant medical specialty (e.g., Internal Medicine, Clinical Pharmacology, Preventive Medicine).
• Significant (e.g., 5-7+ years) post-qualification experience in pharmacovigilance, clinical safety, or a closely related medical field within the pharmaceutical industry or a regulatory agency.
• Demonstrated experience in the strategic application, clinical validation, or medical oversight of digital health technologies or AI/ML solutions.
• Deep understanding of global pharmacovigilance regulations (e.g., FDA, EMA GVP), ICH guidelines, and requirements for the clinical validation of software as a medical device.
• Proven ability to critically evaluate AI/ML methodologies and outputs from a clinical and patient safety perspective.
• Strong understanding of AI/ML concepts, general methodologies, and the AI development lifecycle.
• Exceptional analytical and problem-solving skills.
• Outstanding communication, presentation, and interpersonal skills.
• Proven leadership in managing complex clinical projects, cross-functional teams, or strategic initiatives in a regulated healthcare environment.
• Detailed understanding of the AI ecosystem in healthcare.

Nice To Haves

• Experience in leading or significantly contributing to regulatory interactions regarding digital health tools or AI/ML applications.
• Experience in developing or implementing clinical guidelines, standard operating procedures (SOPs), or best practices for the use of technology in a medical or regulatory context.
• Familiarity with human factors engineering principles and usability assessment for clinical decision support systems.
• Advanced degree (e.g., MPH, MSc, PhD) or other formal training in medical informatics, public health, epidemiology, data science, healthcare administration, or a related field.
• Formal training or certification in medical informatics, data science, or AI in healthcare.
• Published work, presentations, or active participation in industry consortia/working groups related to AI in medicine, digital health, pharmacovigilance, or patient safety.
• Understanding of data governance, data privacy, and cybersecurity considerations relevant to AI in healthcare.

Responsibilities

• Provide expert medical leadership and strategic direction for the integration of AI technologies within patient safety and pharmacovigilance processes.
• Champion the ethical and responsible identification, evaluation, and adoption of innovative AI technologies, including generative AI, to improve the efficiency, accuracy, and depth of patient safety insights.
• Translate complex medical and patient safety requirements into clear objectives for AI development and application, ensuring clinical relevance and utility.
• Stay abreast of advancements in AI in medicine, regulatory guidance on AI in healthcare, and industry best practices, translating these into actionable strategies for Patient Safety.
• Lead the development, implementation, and continuous refinement of a comprehensive clinical validation framework for AI/ML applications in Patient Safety.
• Lead all aspects of the rigorous clinical assessment and validation of AI solutions, ensuring they are medically sound, safe for their intended use, and adhere to global pharmacovigilance regulations.
• Establish and oversee governance processes for the AI lifecycle from a clinical perspective.
• Serve as the primary medical subject matter expert on AI applications within Patient Safety.
• Collaborate closely with Patient Safety Leadership, R&D, Clinical Development, Medical Affairs, IT, Data Science, Quality Assurance, and Global Regulatory Affairs.
• Effectively communicate complex AI concepts and their clinical implications to diverse audiences.
• Lead the clinical due diligence and ongoing medical oversight for external AI partnerships and vendor solutions.
• Represent AstraZeneca's Patient Safety perspective on AI in relevant external forums.
• Maintain a detailed understanding of the evolving AI ecosystem in healthcare.
• Ensure all AI initiatives within Patient Safety comply with global medical regulations, data privacy laws, and ethical guidelines.
• Champion the principles of responsible AI in all Patient Safety AI applications.

Benefits

• Annual base pay ranging from $241,613.60 to $362,420.40.
• Short-term incentive bonus opportunity.
• Eligibility to participate in equity-based long-term incentive program.
• Retirement contribution (hourly roles).
• Commission payment eligibility (sales roles).
• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Health benefits including medical, prescription drug, dental, and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees