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About the Role

Drives the clinical development of assigned asset(s), contributes as Development Team Japan (DT-J) Lead, and represents DT-J to internal/external stakeholders.

Responsibilities

• Leadership of Japan clinical development programs.
• Development and execution of Clinical Development Plan (CDP) in collaboration with Global Asset Team or relevant Global functions.
• Accountabilities as a country level for strategic design and delivery of CDP for assigned asset(s) in line with the target product profiles (TPP) and access considerations.
• Optimization of studies / programs for complexity, schedule, cost, quality.
• Identification of risks and assurance of mitigation plans.
• Incorporation of clinical / medical science insights into the clinical development strategy, plans and study designs.
• Responsible for Japan inputs in the creation of clinical components of key documents (e.g., trial protocols, Investigator’s Brochures, CSRs, regulatory documents) and execution.
• Contribution to successful regulatory filings, approvals, and launches in Japan.
• Support market access, commercialization, and maintenance of product licenses for assigned asset(s).
• Accountable for the comprehensive Japan clinical development programs and studies for assigned asset(s) and applicable indications.
• Accountable and responsible to develop and manage a network of Japan external experts to collect disease and patient unmet need insights that inform clinical development strategy.
• Responsible for providing Japan inputs, defending and updating clinical development plan (CDP) / clinical study design for each indication for the assigned asset, in line with TPP and Japan regulatory (post-approval) requirements in collaboration with Global Asset Team or relevant Global functions.
• Responsible for integrating up-to-date scientific/medical, statistical, Japanese regulatory/HTA, patient and clinical operations insights into a fit-for-purpose CDP/study concept/study protocol considering reduction of overall protocol complexity.
• Accountable for overseeing the ongoing evaluation of study efficacy/safety and data quality, effectively and efficiently interact with partners, key opinion leaders and investigators.
• Accountable for the ongoing evaluation of the benefit/risk ratio of the compound at asset and indication level.
• Accountable for result interpretation (RIM) and reporting (CSR).
• Responsible to lead Japan Development Team (DT-J) assigned asset(s) in a matrix organization.
• Responsible to lead the clinical team in the planning and timely execution of high quality clinical components of regulatory submissions for the indication(s)/formulation(s); contributes to the development and finalization of Japan clinical submission documents.
• Responsible to present and justify Japan clinical development strategic position and plan to internal (Governance bodies at program and study level) and external stakeholders (Regulatory Authorities, strategic partners).
• Responsible for providing drug development and therapeutic expertise to Business Development by contributing to the evaluation of licensing-in compounds.
• Responsible to present at conferences, symposia, and meetings with Japan Investigators and Key Opinion Leaders within the scope of the role.
• Accountable for audit/inspection readiness and overall compliance with regulations (eg, ICH GCP) in Japan and applicable quality standards at all times.

Requirements

• Over 5 years of experience in biopharmaceutical-clinical development is required.
• Experience of strategic design of global clinical programs.
• Experience of oversight of the planning and simultaneous delivery of multiple clinical studies.
• Experience of attendance at meetings with regulatory authorities and applicable external stakeholders.
• Experience of clinical contribution to regulatory submissions and life cycle management.
• Preferably has previously led a part or an entire clinical program.

Skills

• Leadership
• Clinical development strategy
• Clinical Development Plan (CDP) development and execution
• Risk identification and mitigation
• Scientific/medical insights integration
• Regulatory document creation
• Regulatory filings, approvals, and launches
• Market access support
• Commercialization support
• Product license maintenance
• Collaboration with internal stakeholders (Medical Affairs, Commercial, Pharmacovigilance)
• Global Asset Team engagement
• External stakeholder network management (regulatory authorities, key opinion leaders, patient advocacy groups)
• Compliance with regulations, SOPs, and quality standards
• Knowledge sharing
• Clinical study design
• Benefit/risk ratio evaluation
• Result interpretation and reporting
• Matrix organization leadership
• Clinical team leadership
• Regulatory submission document development
• Presentation and justification of clinical development strategy
• Drug development expertise
• Therapeutic expertise
• Business Development evaluation
• Conference presentation
• Audit/inspection readiness

Location

• Japan

Work Type

• Full-time

Experience Level

• Over 5 years of experience
• Preferably has previously led a part or an entire clinical program

Education Level

• Medical Degree (M.D.) - Preferred

About the Company

• UCB is a global biopharmaceutical company focusing on the fields of neurology and immunology.
• Around 8,500 employees worldwide are inspired by patients and driven by science.
• At UCB, we value creating value, not just doing work.
• We strive to achieve results for patients by embracing challenges, collaborating, and pursuing innovation.
• A culture of compassion and support is embedded, where everyone is respected, accepted, and can do their best.
• We always aim for 'what's next', delivering human-centered value for patients, employees, and the planet.
• Working at UCB allows you to experience personal growth, build your career freely, and reach your full potential.

Equal Opportunity

• UCB values equal opportunity.
• All hiring decisions are made regardless of any legally protected attribute.
• If you require special consideration during the selection process to fully demonstrate your strengths and abilities, please contact EMEA-Reasonable_Accommodation@ucb.com.
• Please note that this contact point is only for consultations regarding special considerations in the selection process.