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Global Principal Expert, Clinical Strategy - Clinical R&D
OctapharmaGlobal Principal Expert Clinical Strategy leading clinical development strategies for Octapharma, a major human protein manufacturer. Driving innovative clinical approaches and collaborating across functions.
About the role
Key responsibilities & impact- Lead the development of global clinical strategies across all phases of clinical development
- Develop integrated, patient-centric clinical development plans aligned with scientific, regulatory and business objectives
- Provide strategic oversight for study concepts, clinical protocols and key development deliverables
- Drive innovative clinical development approaches, including novel trial designs and real-world evidence generation
- Partner with Regulatory Affairs to support global regulatory strategies and health authority interactions
- Collaborate across Clinical Development, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs and Business Unit functions to ensure successful program execution
- Build strong relationships with external experts, investigators, key opinion leaders and regulatory authorities
Requirements
What you’ll need- Completed degree in Medicine, Pharmacy, Life Sciences or another relevant scientific discipline (MD, PharmD or PhD preferred)
- Experience in pharmaceutical or CRO clinical development, including a minimum of 10 years in clinical research
- Strong expertise in protocol development, clinical study design, clinical study reports and clinical development planning
- Demonstrated experience with regulatory interactions, including FDA Type B/C meetings, EMA/FDA Scientific Advice, IND/CTA and NDA/BLA/MAA submissions
- Strong scientific, analytical and strategic thinking skills with the ability to evaluate opportunities, risks and development scenarios
- Excellent stakeholder management skills with the ability to influence senior internal and external partners
- Fluent in English; additional languages are beneficial
- Excellent organizational skills, a proactive mindset and the ability to manage multiple strategic priorities
- Willingness to travel internationally as required
Benefits
Comp & perks- Company restaurant & meal subsidy
- Training & further education
- Health promotion
- Parking spaces and good public transport connections
- Company and team events
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical ResearchClinical Study ReportsFDA Type B/C MeetingsEMA/FDA Scientific AdviceIND/CTA SubmissionsNDA/BLA/MAA SubmissionsAnalytical SkillsStrategic Thinking
Soft Skills
Excellent Organizational SkillsProactive MindsetInfluencing Skills
Certifications
MDPharmDPhD