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About the Role
As a senior strategic advisor and subject matter expert in drug development, you will provide recommendations to support the critical decision-making of clients' management and development executives. You will integrate scientific validity, regulatory feasibility, commercial objectives, development risks, and resource allocation to deliver practical and valuable strategic recommendations. As a member of the RADDS Japan Leadership Team, you will enhance drug development strategy consulting capabilities and contribute to the sustainable growth and operational advancement of RADDS Japan.
Responsibilities
- Develop and propose integrated drug development strategies for pharmaceutical and biotechnology companies.
- Formulate and review Target Product Profiles (TPP), Clinical Development Plans (CDP), development roadmaps, and clinical evidence strategies.
- Advise on indication prioritization, endpoint strategies, development sequencing, global and Japanese development strategies, international collaborative trial participation, and development acceleration opportunities.
- Support PMDA consultation strategies, regulatory authority meeting preparation, development risk assessments, gap analyses, and response strategies for inquiries.
- Collaborate with internal and external experts in regulatory affairs, clinical science, statistics, medical writing, and real-world evidence.
- Conduct due diligence and evaluate development candidates for licensing, M&A, and portfolio prioritization.
- Lead workshops for management, strategy meetings, advisory boards, and governance meetings.
- Contribute to proposal creation, deal formation, thought leadership activities, and strategic account growth.
- Participate in the business strategy and annual business plan of RADDS Japan, operational process improvements, and service delivery model optimization.
- Build internal and external expert networks, facilitate knowledge sharing, and develop methodologies and frameworks.
- Contribute to the recruitment, onboarding, coaching, mentoring, and training of consulting professionals.
Requirements
- Over 10 years of practical experience in drug development, regulatory strategy, clinical development, medical/scientific leadership, or consulting, gained through experience in multiple companies with diverse corporate cultures and development environments.
- Advanced expertise in developing drug development strategies and development plans.
- Practical experience in clinical development within pharmaceutical companies or leadership experience in clinical development strategy/planning.
- Deep understanding of the Japanese regulatory environment, including PMDA.
- Experience leading complex strategic consulting projects or cross-functional development projects.
- Knowledge and experience with TPP, CDP, indication prioritization, endpoint strategies, and benefit-risk assessment.
- Strong communication, facilitation, and advisory skills for management and senior stakeholders in development departments.
- Ability to integrate multiple scientific, regulatory, and business perspectives into actionable strategies.
- A degree in medicine, pharmacy, life sciences, public health, statistics, or a related scientific field, or equivalent industry experience.
- Communication skills in Japanese and English to conduct business with internal and external stakeholders.
Skills
- Drug Development Strategy
- Regulatory Affairs
- Clinical Development
- Strategic Planning
- Consulting
- Communication
- Facilitation
- Leadership
- Cross-functional Collaboration
- Business Development
- Thought Leadership
- Talent Development
Location
- Japan
Work Type
- Full-time
- Contract
Experience Level
- 10+ years
Education Level
- Bachelor's Degree
- Master's Degree
- Doctorate
Benefits
- Social insurance system
- IQVIA original benefit system
- Annual paid leave
- Summer vacation
- Sick leave
- Special leave
- Women's special leave
- Childcare leave
- Nursing care leave
- Nursing leave
About the Company
- IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
- We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Equal Opportunity
- IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.