Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions
Takeda
5 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
- Oversee regulated post-authorization clinical research and pharmacovigilance activities in commercial business units and affiliates.
- Provide clinical research and pharmacovigilance regulatory expertise: compliance interpretation, consultation, and recommendations.
- Ensure Global Quality Audit risk-based strategies/programs include clinical research and pharmacovigilance activities (including supplier/internal systems audits); participate in audit planning and help mitigate identified risks.
- Provide expert input into high/medium and/or potential systemic quality investigations in clinical research and pharmacovigilance areas (including serious breach and scientific misconduct); liaise with R&D and CPMQ; escalate critical non-compliance/insufficient remediation urgency to Senior Management.
- Support inspections by ensuring risks are communicated within GPD and Global Quality.
- Contribute to fit-for-purpose Key Quality Indicators (KQIs) and metrics relevant to clinical research/pharmacovigilance risks impacting marketing authorization holders (MAHs); support quality/compliance governance (e.g., Quality Council) for the business units and affiliates.
- Use CPMQ data trends/insights to analyze and communicate post-authorization and commercial perspectives.
- 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.
Qualifications
- BSc in a scientific or allied health/medical field (or equivalent).
- Minimum 10 years of increasing-responsibility experience in the global pharmaceutical industry, including at least 3 years in Quality/Compliance.
- Advanced knowledge of clinical research, medical affairs activities, and pharmaceutical commercial operations.
- Experience with cross-functional/enterprise collaborations, especially between R&D and Commercial.
- Experience working in complex organizations with senior/executive stakeholders.
Skills
- Excellent communication (public speaking, writing, interpersonal) and exceptional active listening.
- Strong critical thinking and problem-solving; ability to advocate for solutions.
- Leadership and interpersonal skills; encourages open discussion and differing viewpoints; sound judgment and independent initiative.
- Ability to translate and communicate impacts of significant/complex issues.
- Collaboration skills; builds strong relationships across all organizational levels.
- Fluency in written and spoken English; additional language skills a plus.
Licenses/Certifications (preferred)
- MBA or Quality Assurance certification (e.g., Lean Six Sigma).
Travel
- Willingness to travel (including overnight); ~10% travel; some international travel may be required.
Responsibilities
- Oversee regulated post-authorization clinical research and pharmacovigilance activities in commercial business units and affiliates.
- Provide clinical research and pharmacovigilance regulatory expertise: compliance interpretation, consultation, and recommendations.
- Ensure Global Quality Audit risk-based strategies/programs include clinical research and pharmacovigilance activities (including supplier/internal systems audits); participate in audit planning and help mitigate identified risks.
- Provide expert input into high/medium and/or potential systemic quality investigations in clinical research and pharmacovigilance areas (including serious breach and scientific misconduct); liaise with R&D and CPMQ; escalate critical non-compliance/insufficient remediation urgency to Senior Management.
- Support inspections by ensuring risks are communicated within GPD and Global Quality.
- Contribute to fit-for-purpose Key Quality Indicators (KQIs) and metrics relevant to clinical research/pharmacovigilance risks impacting marketing authorization holders (MAHs); support quality/compliance governance (e.g., Quality Council) for the business units and affiliates.
- Use CPMQ data trends/insights to analyze and communicate post-authorization and commercial perspectives.
- 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.
Qualifications
- BSc in a scientific or allied health/medical field (or equivalent).
- Minimum 10 years of increasing-responsibility experience in the global pharmaceutical industry, including at least 3 years in Quality/Compliance.
- Advanced knowledge of clinical research, medical affairs activities, and pharmaceutical commercial operations.
- Experience with cross-functional/enterprise collaborations, especially between R&D and Commercial.
- Experience working in complex organizations with senior/executive stakeholders.
Skills
- Excellent communication (public speaking, writing, interpersonal) and exceptional active listening.
- Strong critical thinking and problem-solving; ability to advocate for solutions.
- Leadership and interpersonal skills; encourages open discussion and differing viewpoints; sound judgment and independent initiative.
- Ability to translate and communicate impacts of significant/complex issues.
- Collaboration skills; builds strong relationships across all organizational levels.
- Fluency in written and spoken English; additional language skills a plus.
Licenses/Certifications (preferred)
- MBA or Quality Assurance certification (e.g., Lean Six Sigma).
Travel
- Willingness to travel (including overnight); ~10% travel; some international travel may be required.