【AstraZeneca】【R&D】Japan Precision Medicine Lead, 研究開発本部 薬事統括部 薬事プレシジョンメディシン戦略部

Job Description:

• Japan Precision Medicine Lead (JPML) is responsible for planning and execution of Japan regulatory strategy of diagnostics (Dx), including Companion Dx (CDx) and Complementary Dx (CoDx) of the assigned products/projects by
  • Providing strategic regulatory and scientific expertise for optimum market access of the products in Japan as a core member of Japan Project Team (JPT)
  • Leading communication of the global Dx strategy and its implication to Japan so that the context of Japan input is properly understood by Global Product Teams (GPTs)
• JPML works for developing and providing the network for the strategic external interactions with External Experts (EEs) in Japan health authorities, academia, and industry relating to the drug development

Responsibilities :

• Lead Dx strategies of the products to make sure they are consistent with the business objectives, including identification of the regulatory risks, mitigations of the risks, strategy for HA interactions and engagement of key stakeholders properly
• Lead discussions on biomarkers which may be required to develop as Dx;
  • Lead scientific component in the interaction with Japanese researchers relating to Dx
  • Lead patient selection strategies using the biomarker tests related to assigned drug development products in collaboration with Global Precision Medicine, Bioscience, and JPT
  • Provide scientific support to site investigators, including information on biomarkers, to ensure the smooth implementation of AZ’s clinical studies
  • Review the clinical study-related documents (such as CSP, MICF, Scientific Justification documents etc.) from a biomarker science perspective
  • Lead the strategy for biomarkers in early and late-stage projects, preparing and executing clinical studies in collaboration with Global Translational Medicine and Precision Medicine & Biosamples and JPT
• Deliver regulatory and scientific component of the Dx development plan in line with drug product strategy, including assessment of the approvability of the Dx together with risk mitigations
• Lead regulatory interactions with health authorities related to Dx, such as authoring of briefing documents for PMDA consultation, query responses, in collaboration with Global Precision Medicine, external diagnostic partners, and JPT to ensure the approval of Dx as part of JNDA submission activities for drugs that require Dx
• Work with JPT/Global relevant functions to develop strategy for new technologies with relevant regulatory guidelines and understand the corresponding clinical and scientific components
• Support junior or less experienced staffs by providing guidance and encouragement to solve　product-related issues
• Deliver the non-product functional initiatives in the cross-functional task forces

Requirements:

Education

• Undergraduate degree required

Experience

• Experience in pharmaceutical development including Dx development in Japan
• Experience in regulatory interactions with health authorities and JNDA submissions, including CTD preparation
• Knowledgeable as a scientist in fields such as pharmacology, bioscience, biology, and life 　medicine/science
• Well-versed in the drug/Dx development process and relevant regulatory guidance/guidelines,　including ICH guideline, within the Japanese pharmaceutical industry
• Cross-functional project team experience
• Thorough knowledge of the drug development process
• Written and verbal communication skills
• Scientific knowledge sufficient to understand all aspects of regulatory issues
• Demonstrated experience in regulatory drug/device development
• Proven leadership and program management experience
• Ability to think strategically and critically evaluate risks to regulatory activities

Preferred Experience

• Diagnostic development expertise
• Experience in planning and implementing translational research within the pharmaceutical industry
• Experience or knowledge in Software as Medical Device, computational pathology and/or data science
• Drug development and regulatory affairs experience in outside of Japan
• Working with external bodies, such as co-development companies and key opinion leaders, as a leading person

Skills and Capabilities

• Assertive communication skill (Achieve common understanding at the context level with customers)
• Logical thinking (Reviews and structures knowledge to reach clear conclusions)
• Project management skill
• Business English (Speaking level 6 or above, Achieve common understanding at the context level with customers)
• Strategic influencing/negotiation skill (Through well thought out rationale and effective communication skills, able to influence key decisions)
• Analytical Thinking (Logically breaking situations or issues down into their essential elements;  carrying out diagnosis and developing solutions)
• Builds effective partnerships (identified opportunities and takes actions to build effective  relationships within team and with other areas)

【キャリアレベル/Career Level】E

【勤務地/Location】Osaka or Tokyo

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.