【職務内容 / Job Description】

Medical Scientist (MS) is accountable/responsible for the medical science expertise to generate clinical development strategy, design clinical development options, and deliver successful clinical development of responsible products in Japan. 

His/Her ccountability/responsibility is mainly project-level, however, he/she is partially involved in study-level activities, too, in order to achieve project-level delivery.

Accountability/Responsibility

1 Project Level

1.1 Design & Interpretation / D&I

• 1.1.1 Generate Japan clinical development strategy with Project Physician by applying own multidisciplinary medical science expertise, including medical, translational, regulatory science and project management. Manage and drive technical discussion in a Japan Design & Interpretation (D&I) Team as a team leader and consolidate scientific inputs from physicians, statisticians, QCP experts, translational scientists, and other relevant members (e.g., regulatory, CMC, and external experts).
• 1.1.2 Generate high-quality design options that characterize benefit, risk and value of medicinal products, focusing on reducing uncertainties and providing clear and transparent recommendations for decision and governance bodies.

1.2 Planning

• 1.2.1 Ensure and champion consistent clinical science aspects and strategies across programs. 
• 1.2.2 Ensure optimal management of high impact project opportunities and risks.
• 1.2.3 Review study design, regulatory documents consistent with the clinical strategy.
• 1.2.4 Ensure delivering rationalized hypothesis, evidence based argument, and convincing interpretation in clinical science related documents.
• 1.2.5 Input scientific information to internal documentation/slides such as IDP/CDP and governance document.

1.3 PMDA interaction

• 1.3.1 Co-develop clinical science part of regulatory related documents with Project Physicians; e.g., PMDA consultation BD, query responses, etc.

1.4 JNDA

• 1.4.1 Lead JNDA clinical satellite team activities and be point of contact to JNDA Lead and global CPT.

1.5 KEE management

• 1.5.1 Support key contacts with external experts and help develop clinic-scientific alliance working with Project Physicians and global CPT.
• 1.5.2 Act as a key point of contact for clinical science related relationship with external experts.

2 Study Level

2.1 Planning

• 2.1.1 For Japanese standalone development projects, support Japan Project Physician in developing clinical science part of clinical trial documents, e.g., study design concept, study protocol.

2.2 Execution

• 2.2.1 Provide clinical science support such as efficacy and safety data review to specific studies for risk mitigation.
• 2.2.2 Provide clinic-scientific leadership to non-interventional study planning and reflect results on Japan D&I activities.
• 2.2.3 Provide clinic-scientific leadership and support ESR in Japan.

2.3 Publication

• 2.3.1 Input to publication strategy and contents/quality of publications.

3 Collaboration with Marketing Company

3.1 External expert selection & development

• 3.1.1 Support external expert selection and their development collaborating with Medical Affairs.

3.2 For product value maximization

• 3.2.1 Act as a point of contact to Medical Affairs to collaborate on e.g., data generation to maximize product value.

4 Others

4.1 Compliance to company rules and external regulations

• 4.1.1 Ensure that own work and all work within TA is performed in accordance with appropriate SHE and Compliance standards.

4.2 Tasks outside projects

• 4.2.1 Assumes other duties as assigned by the Medical Science Director.

5. Education & Experience

5.1 Education & Degree

5.1.1 Required:

• Life Science related Bachelor degree required

5.1.2 Preferred:

• Doctor of Philosophy preferred

5.2 Experience

5.2.1 Required:

• 5 years or longer experience of working on drug development in pharmaceutical industry

5.2.2 Preferred:

• Clinical science strategy planning in drug development
• Negotiations with external experts
• Planning of clinical science strategies as a Japan clinical science representative at the cross-functional team
• Quality of knowledge on drug development strategy and clinical science
• Experience on negotiation with PMDA/MHLW, and getting JNDA/sJNDA approval and supporting launch activities

5.3 Skills & Capabilities

• Project management skill
• Assertive communication skill
• Business English
• Strategic influencing skill
• Conceptual Thinking
• Negotiation skill
• Logical thinking skill
• Ability to work in a complex, business critical and high profile environment building credibility in ambiguous situations
• Rapid adaptability to a new environment
• Leadership capability

6. Feeder Roles

• The person who meets the requirements above

7. Measure of Success

• The context of medical science input into clinical development plan in Japan, including scientific risks, mitigations and setting right expectation of clinical development PTS (Probability of Technical Success), is properly understood by the internal governance bodies for their quality decisions and by the internal stakeholders for the engagement.
• Optimum clinical science strategy is provided for optimum market access of the products within TA portfolio

8. Reporting Relationship

• Report to TA Medical Science Director
• Direct reports: None

【応募資格（経験、資格等）/ Qualification (Experience & Skill etc)】

◆◆経験 / Experience◆◆

＜必須 / Mandatory＞

• 5 years or longer experience of working on drug  development  in pharmaceutical industry

＜歓迎 / Nice to have＞

• Clinical science strategy planning in drug development
• Negotiations with external experts
• Planning of clinical science strategies as a Japan clinical science representative at the cross-functional team
• Quality of knowledge on drug development strategy and clinical science
• Experience on negotiation with PMDA/MHLW,  and getting JNDA/sJNDA approval and supporting launch activities

◆◆資格 / License◆◆

＜必須 / Mandatory＞

• Life Science related Bachelor degree

◆◆能力 / Skill-set◆◆

＜必須 / Mandatory＞

• Project management skill
• Assertive communication skill
• Strategic influencing skill
• Conceptual Thinking
• Negotiation skill
• Logical thinking skill
• Ability to work in a complex, business critical and high profile environment building credibility in ambiguous situations
• Rapid adaptability to a new environment
• Leadership capability

◆◆語学 / Languages◆◆

＜必須 / Mandatory＞

• Business English
• Native level Japanese

◆◆勤務地 / Work Location◆◆

• Osaka or Tokyo

◆◆ｷｬﾘｱﾚﾍﾞﾙ / Career Level◆◆

• D or E (depends on experience)

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.