Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions

Role Summary

Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business units and affiliates. The role contributes to and implements engagement strategies among R&D, business units, affiliates, and quality to ensure a global framework and robust quality systems for the transition of R&D pipeline to the commercial space. It drives a fit-for-use global Quality framework that elevates capabilities across business units and affiliates to deliver regulated clinical research and pharmacovigilance activities with high compliance and agility. The role establishes and maintains relationships with key stakeholders outside R&D to support post-authorization strategies through collaboration and escalation as needed.

Responsibilities

• Provide expertise in clinical research and pharmacovigilance regulations and compliance interpretation, consultation and recommendations to relevant functions in the business units and affiliates.
• Ensure Global Quality Audit functions consider clinical research and pharmacovigilance activities in risk-based audit strategies and programs, including supplier and internal audits; participate in audit planning and mitigate identified risks with responsible partners.
• Provide expert input in high to medium and/or potential systemic quality investigations in the clinical research and pharmacovigilance areas; liaise with R&D and CPMQ personnel; escalate critical non-compliance issues to Senior Management.
• Support inspections to ensure risks are well-communicated within Global Portfolio Division and Global Quality organizations.
• Provide input to Global Quality on fit-for-purpose Key Quality Indicators and metrics relevant to clinical research and pharmacovigilance risks impacting MAHs; analyze and communicate risks; contribute to quality governance for the business units and affiliates under GPD.
• Ensure post-authorization and commercial perspectives are analyzed using CPMQ data trends and insights; communicate trends to stakeholders in Global Portfolio Division and Global Quality.
• Drive a fit-for-use global Quality framework that elevates affiliate capabilities and enables compliant and agile delivery of regulated activities (including evidence generation studies, patient access programs, IIR, collaborative research, RWE/RWD); champion proactive and innovative approaches and engage Quality and business leaders for collaboration.

Qualifications

• BSc in a scientific or allied health/medical field (or equivalent degree).
• Minimum of 10 years of increasing responsibility and relevant experience in the global pharmaceutical industry, with at least 3 years in Quality/Compliance.
• Advanced knowledge of clinical research, medical affairs activities and pharmaceutical commercial operations.
• Experience includes cross-functional and enterprise collaborations, particularly between R&D and Commercial.
• Experience working within complex organizations with senior staff and executive-level colleagues.
• Excellent communication skills in public speaking, writing, and interpersonal interactions; strong active listening skills.
• Strong critical thinking and problem-solving abilities; ability to advocate for solutions.
• Leadership and interpersonal skills; capable of fostering open discussion and collaboration; sound judgment and initiative.
• Ability to translate complex issues into clear communications and foster collaboration across organizational levels.
• Fluency in written and spoken English; additional languages a plus.

Education

• BSc in a scientific or allied health/medical field (or equivalent degree).

Additional Requirements

• Willingness to travel to various meetings, including overnight trips; some international travel may be required.
• Requires approximately 10% travel.