Senior Manager Clinical Pharmacology

Make your mark for patients

患者さんのためにあなたの力を発揮してください

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:

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.

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.

Where appropriate, drive strategies for novel (or non-standard) regulatory agency  data expectations for regional drug approvals

Responsible for clinical pharmacology activities, timelines and resources with adequate quality

Ensure that processes, SOPs, and standardized training/tools exist to facilitate consistent, efficient and compliant clinical pharmacology deliverables

Establish good relationship with Contract Research Organizations (CROs) for Clinical Pharmacology activities

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

In concordance with respective global processes, lead to establish, as well as continually improve, regional standards of procedures, tools and technologies for clinical pharmacology

Collaborate to provide input into global strategic/technical aspects

Assist to planning and controlling functional budget.

MAJOR ACCOUNTABILITIES

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.

Responsibility/co-responsibility for Clinical Pharmacology parts of main documents including Investigator’s Brochures, Protocols, Clinical Study Reports and all submission relevant documents

Assessment of the scientific/medical quality of external Clinical Pharmacology Units in close collaboration with Global Exploratory Development and Outsourcing & Contracting

Represents/co-represents Clinical Pharmacology for market approval submission to regulatory authorities, authority meetings and answers to all related authority questions

Input to licensing projects on demand of Business Development or others as well as active scouting for potential relevant projects for in-licensing

Cooperation with Commercial functions including publications, presentations, conference participation

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)

Ensure that processes, SOPs, and standardized training/tools exist to facilitate consistent, efficient and compliant clinical pharmacology deliverables

Establish good relationship with Contract Research Organizations (CROs) for clinical pharmacology activities.

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

Establish the network with external specialists (PK & Clinical Pharmacology field )

Establish the network with UCB Global counterparts

Be responsible for functional activities

Lead to establish standards of procedures, tools for clinical pharmacology

Lead the continuous improvement of the processes and technologies of clinical pharmacology

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.

患者さんのために価値を創造し、ご自身の力を発揮する準備ができているとお感じでしたら、ぜひ私たちにご連絡ください。

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。

UCBで働くことで、自分自身の成長を実感し、自由にキャリアを築き、可能性を最大限に引き出すことができます。

UCBでは機会均等を重視しています。すべての採用決定は、法律で保護されているいかなる属性にも関係なく行われます。

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

※なお、この問い合わせ先では選考における特別な配慮に関するご相談以外はお受けできませんので、ご注意ください。