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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in clinical development, compliance, and business process ownership within the pharmaceutical industry, with a strong focus on strategic leadership, change management, and team development. Proven ability to oversee clinical systems and ensure adherence to regulatory standards while fostering a culture of continuous improvement.
Highest-signal resume keywords
Clinical DevelopmentChange ManagementProject ManagementRegulatory ComplianceLeadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical OperationsDrug Development ProcessesICH-GCP Guidelines21 CFR Part 11Audit/Inspection ReadinessETMFCTMSQMSBusiness Process DesignPerformance Management
Soft Skills
Strategic LeadershipInfluencingProblem SolvingAgile MindsetTeam Development
Tools & Technologies
CTMSETMFLMSQuality Management Systems
Industry Keywords
PharmaceuticalBiotechClinical TrialsComplianceQuality AssuranceHealth Authority Regulations
About the role
Key responsibilities & impact- Establish and optimize key capabilities for internal business process ownership, clinical systems business management, training, and compliance
- Lead a team of approximately 6 direct reports and contribute to CDO strategy and priorities
- Partner with R&D, Medical, IT, Quality, Regulatory, Digital/Data, HR Learning, and other enabling functions
- Provide strategic leadership to a multifunctional team across compliance, training, systems support, and business process ownership
- Coach, mentor, and develop team members
- Contribute to organizational strategy, portfolio execution, and cross-functional decision-making
- Lead and sponsor change initiatives supporting adoption of new processes, systems, and ways of working
- Define and oversee IPSEN’s Clinical Development SOP strategy and Business Process Ownership framework
- Ensure SOPs are fit for purpose, incorporate audit corrective actions, and are effectively reviewed, approved, and implemented
- Provide strategic oversight of CTMS, TMF, and related clinical systems, including roadmaps, integrations, governance, data stewardship, quality, and compliance
- Oversee prioritization, resource allocation, performance management, system evolution, adoption, user experience, and digital transformation
- Oversee global role-based training curricula, onboarding programs, competency frameworks, LMS compliance, and auditable documentation
- Monitor training performance using metrics, dashboards, and compliance indicators
- Direct the Compliance team and oversee compliance risk monitoring, mitigation, remediation, QC checks, TMF/training documentation reviews, audits, inspections, and Quality Reviews
- Ensure CAPA governance, regulatory intelligence assessment, procedural document updates, onboarding and handover processes, and centralized storage/retrieval of required documents
- Monitor emerging compliance concerns and procedural deviations, trend audit/inspection root causes, and drive lessons-learned and process/training adjustments
Requirements
What you’ll need- 10+ years’ experience within pharmaceutical/biotech or related industry with a track record of transformational leadership across a global cross-functional working environment
- Experience in clinical development, clinical operations, quality, compliance, or related areas in the pharmaceutical or biotech industry
- Deep understanding of the clinical trial landscape
- Extensive demonstrated knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, and major Health Authority regulations
- Experience in audit/inspection readiness, preparation, and conduct
- Visionary and strategic leadership ability
- Experience in large-scale organisational change management/implementation programs
- Proven influencer and change agent with superior project management capabilities
- Project management excellence in planning, prioritisation, problem solving, and organisational skills
- Ability to manage multiple priorities in a dynamic environment; agile mindset
- Experience managing internal stakeholders and communicating across all levels of the organization up to ELT level
- 6+ years’ people/project management experience
- Extensive knowledge of Good Clinical Practice and related global regulatory and compliance requirements for clinical studies
- Strong understanding of clinical systems (eTMF, CTMS, QMS, etc.) and business process design
- Effective leadership skills and proven ability to foster team productivity and cohesiveness in a changing environment
- Sound financial acumen
- Minimum bachelor’s degree (university/college degree) in a scientific discipline or general management
- English
Benefits
Comp & perks- Inclusion and equal opportunities commitment
- Application process adjustments or support for candidates requiring them
- Support information handled with care and not affecting application outcome