Clinical Development Lead

Make your mark for patients

/Hybrid work model

Please check if the candidate has applied for a job at UCB in the past year.

Please make English and Japanese resume combined in one document to submit

If you have any questions please contact recruiting team

JOB SUMMARY
Clinical Development Lead drives the clinical development of assigned asset(s) contributes as Development Team Japan (DT-J) Lead and is a representative of DT-J to internal/external stakeholders.
Key Responsibilities:
Leadership of elements 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 to be implemented
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 Investigators 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)
Major Accountabilities:
Collaboration: Maintain excellent working relationships within teams and internal stakeholders (e.g. Medical Affairs Commercial Pharmacovigilance) to meet objectives. Well contributed and engaged global Asset Team and relevant global functions
Strategy: Provide Japan input and contribute to the development and revisions of CDPs ensuring alignment with TPP
Regulatory Submissions: Contribute to clinical components of regulatory submissions in Japan including development of briefing book and answers for questions from HA ensuring timely delivery
External Collaboration: As the medical / scientific expert develop and manage a network of Japan external stakeholders (e.g. regulatory authorities key opinion leaders patient advocacy groups)
Compliance: Ensure program compliance with regulations SOPs and quality standards.
Knowledge Sharing: Share clinical program knowledge across the organization and ensure lessons learned are applied to future programs

MAJOR ACCOUNTABILITIES
Describe the main accountabilities for this role including significant tasks responsibilities and projects
1. Accountable for the comprehensive Japan clinical development programs and studies for assigned asset(s) and applicable indications
a. 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
b. 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
c. 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
d. Accountable for overseeing the ongoing evaluation of study efficacy/safety and data quality effectively and efficiently interact with partners key opinion leaders and investigators
e. Accountable for the ongoing evaluation of the benefit/risk ratio of the compound at asset and indication level
f. Accountable for result interpretation (RIM) and reporting (CSR)
2. Responsible to lead Japan Development Team (DT-J) assigned asset(s) in a matrix organization
3. 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
4. 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)
5. Responsible for providing drug development and therapeutic expertise to Business Development by contributing to the evaluation of licensing-in compounds
6. Responsible to present at conferences symposia and meetings with Japan Investigators and Key Opinion Leaders within the scope of the role
7. Accountable for audit/inspection readiness and overall compliance with regulations (eg ICH GCP) in Japan and applicable quality standards at all times

EDUCATION & QUALIFICATION
Education & experience necessary for this role
Education Level
1 Bachelors Degree in life science / healthcare - Required
1 Masters Degree - Preferred
Ph.D. - Preferred
0 Law (J.D.)
1 Medical Degree (M.D.) - Preferred
Other (Describe): PharmD - Preferred

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

COMPETENCIES
Leadership:
Ability to build and lead high performing team that integrates multidiciplinary insights into robust strategic and operational plans and display confident decision making skills to lead multidiciplinary teams in a matrix environment.
Ability to effectively manage internal (at all levels in the organization) and external stakeholder relationships influence and drive deliverables.
Ability to work autonomously to address complex technical problems and manage conflict
Project Leadership: Clinical Development Lead oversee Japan clinical development programs clinical studies and/or specific projects ensuring that goals are met within set timelines and budgets.
Team Leadership: They manage teams providing guidance and support to ensure productivity and morale.
Networking: Effectively navigates formal and informal channels to get things done.
Decision making: Makes relevant decisions in close collaboration with relevant stakeholders.
Innovation and entrepreneurial:
Possesses a growth mindset; ability to challenge current thinking construct alternative scenarios that deliver speed quality and competitiveness with appropriate risk assessment and mitigation.
Displays a positive attitude in the face of ambiguity and change. Ability to inform decisions in uncertainty and adversity.
Technical:
Good current knowledge of all aspects of global / Japan clinical development.
Able to strategically and tactically design plan and deliver a clinical development program optimised for cost complexity quality and speed in accordance with TPP to enable global patient access.
Technical savvy in using electronic systems digital media AI
Communication Skill
Excellent communication skills demonstrating clear and articulate verbal written and presentation skills with excellent command of the English language and the appropriate comportment for internal communication and to represent UCB externally
Verbal and Written Communication: Effective communication with team members stakeholders and other departments is crucial. Succeeds in convincing others by communication expertise and with sound rationale. Directors must articulate goals expectations and feedback clearly.
Presentation Skills: Strong presentation skills are necessary. Clinical Development Lead may present project updates and results to senior management and external stakeholders.
Strategic Thinking and Decision-Making
Problem-Solving: Clinical Development Lead address operational challenges and make decisions that optimize processes and outcomes.
Analytical Skills: They analyze data and trends to inform decision-making and improve team performance.
Regulatory and Compliance Knowledge
Regulatory Strategy: Clinical Development Lead is part of discussions with regulatory authorities and contribute to the development of regulatory strategies.
Compliance Management: Ensuring that the clinical team adheres to relevant regulations and standards is a key responsibility.
Risk Management: Clinical Development Lead identify and mitigate risks associated with individuals their projects teams or enterprise level.
Operational Efficiency
Resource Allocation: Clinical Development Lead manage resources effectively to maximize efficiency and achieve project as well as departmental goals.
Process Improvement: They implement process improvements to enhance productivity and quality.
Stakeholder Management and networking:
Building and maintaining high-level relationships with key opinion leaders regulatory authorities and other external stakeholders.
Representing the company at major conferences and symposia.
Regulatory and Compliance knowledge:
Ensuring compliance with global regulatory standards and guidelines.

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