Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions
Takeda
13 hours ago
Remote
United States
$154,400 - $242,550 USD yearly
Medical Affairs
Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions (US Remote)
Responsibilities
- Provide clinical research and pharmacovigilance regulatory expertise, compliance interpretation, consultation, and recommendations to business units and affiliates.
- Ensure Global Quality Audit includes clinical research and pharmacovigilance activities in its risk-based audit strategy/programs (including supplier and internal systems audits); participate in audit planning and help mitigate identified risks.
- Provide expert input into high-/medium-potential and systemic quality investigations in business units/affiliates, including serious breach and scientific misconduct; liaise with R&D/CPMQ as needed; escalate critical non-compliance and/or lack of remediation urgency to senior management.
- Support inspections by ensuring risks are appropriately communicated within GPD and Global Quality organizations.
- Provide input to Global Quality on fit-for-purpose Key Quality Indicators (KQIs) and metrics for clinical research and pharmacovigilance risks impacting marketing authorization holders (MAHs); contribute to quality/compliance governance (e.g., Quality Council).
- Analyze and communicate post-authorization/commercial trends and insights using CPMQ data.
- Drive a fit-for-use global quality framework to enable affiliates to deliver regulated activities (evidence generation studies, patient access programs, IIR, collaborative research, RWE/RWD) with high compliance and agility; champion proactive/innovative approaches.
Qualifications
- BSc in a scientific or allied health/medical field (or equivalent).
- 10+ years of increasing responsibility in the global pharmaceutical industry; at least 3 years in Quality/Compliance.
- Advanced knowledge of clinical research, medical affairs activities, and pharmaceutical commercial operations.
- Cross-functional/enterprise collaboration experience, especially between R&D and Commercial.
- Experience working in complex organizations with senior/executive colleagues.
Skills/Competencies (required)
- Excellent communication (public speaking, writing, and interpersonal) and strong active listening.
- Critical thinking and problem-solving; ability to advocate for solutions.
- Strong leadership and interpersonal skills; encourages open exchange of ideas and viewpoints; sound judgment and independent initiative.
- Ability to collaborate and deliver results through others; build strong relationships across all organizational levels.
- Ability to succinctly translate and communicate impact of significant, complex issues.
- Fluency in written and spoken English.
Preferred
- MBA or Quality Assurance certification (e.g., Lean Six Sigma).
- Additional language skills.
Travel
- Willingness to travel (including overnight trips); approximately 10% travel; some international travel may be required.
Responsibilities
- Provide clinical research and pharmacovigilance regulatory expertise, compliance interpretation, consultation, and recommendations to business units and affiliates.
- Ensure Global Quality Audit includes clinical research and pharmacovigilance activities in its risk-based audit strategy/programs (including supplier and internal systems audits); participate in audit planning and help mitigate identified risks.
- Provide expert input into high-/medium-potential and systemic quality investigations in business units/affiliates, including serious breach and scientific misconduct; liaise with R&D/CPMQ as needed; escalate critical non-compliance and/or lack of remediation urgency to senior management.
- Support inspections by ensuring risks are appropriately communicated within GPD and Global Quality organizations.
- Provide input to Global Quality on fit-for-purpose Key Quality Indicators (KQIs) and metrics for clinical research and pharmacovigilance risks impacting marketing authorization holders (MAHs); contribute to quality/compliance governance (e.g., Quality Council).
- Analyze and communicate post-authorization/commercial trends and insights using CPMQ data.
- Drive a fit-for-use global quality framework to enable affiliates to deliver regulated activities (evidence generation studies, patient access programs, IIR, collaborative research, RWE/RWD) with high compliance and agility; champion proactive/innovative approaches.
Qualifications
- BSc in a scientific or allied health/medical field (or equivalent).
- 10+ years of increasing responsibility in the global pharmaceutical industry; at least 3 years in Quality/Compliance.
- Advanced knowledge of clinical research, medical affairs activities, and pharmaceutical commercial operations.
- Cross-functional/enterprise collaboration experience, especially between R&D and Commercial.
- Experience working in complex organizations with senior/executive colleagues.
Skills/Competencies (required)
- Excellent communication (public speaking, writing, and interpersonal) and strong active listening.
- Critical thinking and problem-solving; ability to advocate for solutions.
- Strong leadership and interpersonal skills; encourages open exchange of ideas and viewpoints; sound judgment and independent initiative.
- Ability to collaborate and deliver results through others; build strong relationships across all organizational levels.
- Ability to succinctly translate and communicate impact of significant, complex issues.
- Fluency in written and spoken English.
Preferred
- MBA or Quality Assurance certification (e.g., Lean Six Sigma).
- Additional language skills.
Travel
- Willingness to travel (including overnight trips); approximately 10% travel; some international travel may be required.