Mission
Lead the Global Clinical Program as a core member of the Global Project Team, working cross-functionally with R&D and non-R&D departments to develop strategic clinical plans.
Tasks & Responsibilities
Define clinical development strategies, milestones, and resources for assigned projects in collaboration with cross-functional teams.
Plan and implement Phase 2 and 3 studies, dose finding, and pivotal studies to enable regulatory approval.
Provide clinical/medical leadership within internal cross-functional teams and joint clinical/cross-functional teams for development/market partnerships.
Represent Global Clinical Development at internal meetings and committees, and serve as primary contact for Global Medical Affairs, Market Access, and Marketing.
Guide Clinical Study Teams to ensure alignment of clinical trials conduct and planning with overall development strategy.
Lead the design, delivery, and interpretation of clinical studies results, ensuring ethical and scientific integrity.
Review and approve key clinical trial documents, such as protocols and CSRs.
Ensure data review of ongoing studies and continuous benefit/risk evaluation.
Conduct internal and external peer reviews of study/program design.
Analyze and present clinical trial results for internal and external committees.
Oversee clinical/medical content of study synopsis, protocol, amendments, CSRs, ICF, CRF, and other clinical documents.
Lead scientific meetings/advisory boards with subject matter experts/key opinion leaders to maximize product value and data generation.
Represent Global Clinical Development at meetings with Health Authorities and external stakeholders.
Lead/support study-specific committees, such as IDMC, steering committee, and adjudication committee.
Ensure clinical review/oversight of potential due diligence during evaluation of external opportunities.
Lead/chair the Strategic Clinical Teams.
Education & Experience
Medical degree required, specialty in dermatology preferred.
Advanced Degree (PhD or master's degree in Pharmaceutical Medicine) valuable.
Demonstrated clinical research expertise in Dermatology/Immunology preferred but not required.
At least 3 years of Pharmaceutical Industry experience in drug development.
Understanding of methodology in the design, conduct, review, and interpretation of clinical research.
Significant hands-on clinical drug development experience and scientific credibility.
Fluency in English, proficiency with MS Office.
Skills & Competencies
Data analysis, communication, and presentation skills in team settings and formal presentations.
Strategic leadership skills with influence and consensus building ability.
Proven teamwork and collaboration skills.
Analytical and problem-solving mindset.
Values
Care: listen, empathize, value diverse perspectives, and help each other succeed.
Courage: challenge status quo, take ownership, learn from success/failures.
Innovation: put patient/customer at center, create novel solutions, empower entrepreneurial mindsets.
Simplicity: act decisively, avoid over-analysis, understand why before acting, and be agile/simple.