Senior Manager Clinical Pharmacology

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JOB SUMMARY

This is a regionally-focused, though globally-integrated, role which covers early through late phase development in SE Asia. The primary purposes of this position are:

1. Contribute to assigned projects as Clinical Pharmacology specialist

• Propose exploratory phase clinical development strategy to minimize later stage development timelines in East Asia and to ensure simultaneous development in East Asia with Global development
• Ensure optimal Clinical Pharmacology support to all development programs up to submission for successful regional approvals
• Be responsible for Clinical Pharmacology part of IBs and CTDs, as well as regulatory correspondences and regulatory agency interactions
• Plan and conduct Clinical Pharmacology studies to allow comprehensive compounds’ characterization in Asians, to demonstrate ethnic insensitivity and substantiate CTD
• Understand and champion a model-based approach for drug development to achieve the above objectives.

2. With a global development perspective, drive strategic planning to strengthen the expertise of clinical pharmacology

• Plan adequate allocation of human resource and number of studies, and control budget
• Expand coverage of clinical pharmacology for SE Asian development
• Establish the network with external specialists (PK and Clinical pharmacology field )
• Establish the network with UCB Global counterparts.

3. Where appropriate, drive strategies for novel (or non-standard) regulatory agency  data expectations for regional drug approvals
4. Responsible for clinical pharmacology activities, timelines and resources with adequate quality
5. Ensure that processes, SOPs, and standardized training/tools exist to facilitate consistent, efficient and compliant clinical pharmacology deliverables
6. Establish good relationship with Contract Research Organizations (CROs) for Clinical Pharmacology activities
7. Mentor Clinical Pharmacologists to foster efficient collaboration with all necessary interfaces and to ensure the delivery of reliable and comprehensive deliverables in a timely fashion
8. In concordance with respective global processes, lead to establish, as well as continually improve, regional standards of procedures, tools and technologies for clinical pharmacology
9. Collaborate to provide input into global strategic/technical aspects
10. Assist to planning and controlling functional budget.

MAJOR ACCOUNTABILITIES

1. Responsibility/co-responsibility for the Clinical Pharmacology program(s), pertaining to SE Asia development, for allocated projects including:
   • Develop the Clinical Pharmacology part in Clinical Plan
   • Plan and conduct Clinical Pharmacology study(ies) to assure global data bridging and East Asia’s participation into global P2 and/or P3 trials
   • Representative of Clinical Pharmacology in Joint Clinical Study Team/Development teams
   • Close collaboration with Research, Non-clinical and CS&S and other functions
   • Provide Clinical Pharmacology expertise to assigned Clinical Study and Development teams
   • Assess clinical data to evaluate ethnopharmacology considerations.
2. Responsibility/co-responsibility for Clinical Pharmacology parts of main documents including Investigator’s Brochures, Protocols, Clinical Study Reports and all submission relevant documents
3. Assessment of the scientific/medical quality of external Clinical Pharmacology Units in close collaboration with Global Exploratory Development and Outsourcing & Contracting
4. Represents/co-represents Clinical Pharmacology for market approval submission to regulatory authorities, authority meetings and answers to all related authority questions
5. Input to licensing projects on demand of Business Development or others as well as active scouting for potential relevant projects for in-licensing
6. Cooperation with Commercial functions including publications, presentations, conference participation
7. Responsibility for assigned Clinical Pharmacology trials including communication with the investigator review of the trial and the ethical content of all major documents (protocol, CSR)
8. Ensure that processes, SOPs, and standardized training/tools exist to facilitate consistent, efficient and compliant clinical pharmacology deliverables
9. Establish good relationship with Contract Research Organizations (CROs) for clinical pharmacology activities.
10. Mentor clinical pharmacologists to foster efficient collaboration with all necessary interfaces and to ensure the delivery of reliable and comprehensive deliverables in a timely fashion
11. Establish the network with external specialists (PK & Clinical Pharmacology field )
12. Establish the network with UCB Global counterparts
13. Be responsible for functional activities
14. Lead to establish standards of procedures, tools for clinical pharmacology
15. Lead the continuous improvement of the processes and technologies of clinical pharmacology
16. Assist to planning and controlling functional budget. 

Education Level : Master's Degree

Experience  : 

【Must have】

• 7+ years of overall Clinical R&D experience, including at least 5 years of experience in Clinical Pharmacology
• Strong Clinical Pharmacology expertise, including knowledge of Population Pharmacokinetics, PK/PD Modeling, Pharmacogenomics, and Biostatistics
• Strong understanding of modeling and simulation, with the ability to explain and discuss its application
• Ability to develop and execute Clinical Pharmacology strategies and studies, including Asian/global data bridging
• Experience assessing ethnopharmacology / ethnic sensitivity
• Regulatory and submission experience, including relevant exposure to IBs, protocols, CSRs, CTDs, NDAs, GCP, and applicable guidelines
• Ability to support or represent Clinical Pharmacology in regulatory authority interactions
• Fluent Japanese and business-level English, including both written and verbal communication
• Strong communication, project management, negotiation, problem-solving, and strategic-thinking skills
  

【Preferred Qualifications】

• Model-Based Drug Development
• Strong Population PK / PK-PD modeling expertise
• Experience in Asian/Japanese drug development and ethnic bridging strategies Experience collaborating with global development teams and managing global stakeholders
• Direct interaction with regulatory authorities on Clinical Pharmacology topics
• Experience managing or scientifically assessing CROs / external Clinical Pharmacology units
• Experience establishing or improving SOPs, processes, training, and Clinical Pharmacology tools
• Exposure to Business Development / in-licensing assessments
• Experience with functional budget and resource planning
• Established network with external PK / Clinical Pharmacology specialists
• Experience mentoring or developing Clinical Pharmacologists
• 3+ years of management / leadership experience
• Management experience is required for candidates being considered at the Associate Director level.

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会社概要

UCBは、神経および免疫領域に注力するグローバルなバイオ医薬品企業です。世界中で約8,500人の社員が、患者さんからインスピレーションを受け、科学の力で前進しています。

UCBで働く魅力

UCBでは、単に業務をこなすのではなく、価値を創造することを大切にしています。私たちは挑戦を恐れず、協力し合い、革新を追求しながら、患者さんのために成果を出すことを目指しています。
誰もが尊重され、受け入れられ、最善を尽くせる平等な機会がある、思いやりと支援に満ちた文化が根付いています。
私たちは常に「その先」を目指し、患者さん、社員、そして地球に対して人間らしさを大切にした価値を提供しています。
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選考プロセスにおいて、ご自身の強みや能力を十分に発揮できるよう配慮が必要な場合は、以下のメールアドレスまでご連絡ください：

EMEA-Reasonable_Accommodation@ucb.com

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