■Job Details
Basic purpose of the job:
Manage the timely clinical development(CD) and Health Authority(HA) approval of NBI assets for target indications by providing appropriate and robust insights in [TA name] area, based on Japanese TA-specific and healthcare environment, in collaboration with Corporate&Japan (Early) Asset Team(s), (Early) Evidence Lead(s) and respective Evidence and Value Network

■Accountabilities:
CD Strategy Planning:
- Evaluate and propose Japan (early)CD strategy to achieve asset Target Product Profile(TPP) and value proposition; Ensure CD strategy integrating Japan needs (including but not limited to local medical, competitive landscape and differentiation) in alignment with global asset strategy and agreed by Japan&Corp (early) Asset Team(s).
- Inform respective Evidence Network to highlight the local evidence gaps that are not addressed via Clinical Trials (CTs) for the relevant business function and their planning of Real World Evidence (RWE) generation and input to Asset Evidence Plan(AEP).

G6: When needed, deputize Japan Evidence Lead (EL) in coordinating cross-functional assessment of CD strategy, CT design and/or AEP input

Regulatory strategy and Japan NDA activities:
- Lead building of clinical data package of the assigned asset in collaboration with Evidence and Value Team; build scientific dialogue with HA for the innovation to be recognized for maximizing asset value and accelerated regulatory path.
- Responsible and supervise the content of Japan-Common Technical Document (J-CTD) M2-5, 2-7-3 and 2-7-4 and other clinical part; Contribute to M1-8 and Risk Management Plan(RMP) as a scientific/clinical reviewer; Ensure J-CTD explains the evidence-based value of the asset.
- HA inquiries handling related to the clinical part during J-NDA review period until approval is obtained.

G6: Set the collaboration framework and guide the cross-function team working on clinical dossier delivery; serves as a coach to the team to deliver on time with quality level as agreed.

Project/Knowledge Management:
- In collaboration with Evidence Network members, monitor asset clinical program are executed according to the plan and delivered with quality and speed;　Facilitate the risks, issues and impact assessment on Japan CD strategy execution and deliverables; Facilitate problem solving with relevant business function (e.g., RA, CDO, BDS)
- Collaborate with Corp CPL and Japan Evidence Network to acquire asset/CD strategic information incl HA interaction plans/documents to flawlessly execute CD activities in Japan
- TA-specific knowledge transfer to Medical Affairs function and other relevant business function(s)

G6: Mentor/Coach other CPL in development, serving as a role model, providing counsel and offering a broader perspective; Support mentees/coachees to facilitate their self-discovery of solutions&answers; Support EL/department head to build CPL pipeline

Strategic Insights through External Expert(EE) engagement:
- Engage with Key EEs exchanging scientific/medical data and asset strategy to collect insights and inform asset CD and regulatory strategy; leverage EE engagement in HA interaction as applicable.
- Assess assets’ profile with relevant Evidence Network members and key EEs as applicable.
- Support Medical Advisor(MA) and MSLs to elaborate Clinical Questions which are generated through CD activities and feed into insights generation cycle.
- For early assets where MSLs are not available, start to build the network with Japanese external experts supporting assets in development.

G6: Proactively identify the strategic insights that impact portfolio-level strategy and as applicable, facilitate informed decision making by relevant local/global stakeholders.

CT preparation/execution support:
- Lead PMDA consultation and HA inquiry handling during CT preparation phase and at the implementation of CT amendment if applicable; Provide scientific supervision/advice to the CT dossier for Japan.
- Support CDO on site engagement and communication with EE/site investigator by explaining CD strategy and positioning NBI asset.
- Lead the preparation/revision of IB for Japan and responsible for clinical part of the IB for Japan.
- Provide CDO with CT site recommendation to ensure trial success in terms of recruitment and quality.

■Related performance indicators:
- Provision of Japan input
- Gaps, risks or issues in global CD strategy identified timely and actions/adjustment in place to fill the gap
- CD strategy and/or CT design vetted by and delivered to relevant internal/external stakeholders
- On time delivery of work items as agreed timelines

- Japanese clinical data package aligned with asset strategy, delivered and endorsed by local/global stakeholders
- Logical and strategic steps built to negotiate with PMDA on clinical data package and label indication and aligned with Regional Regulatory Lead and Evidence lead
- Compelling narratives delivered in clinical dossier/HA inquiry response to appeal asset TPP, innovation and differentiation from standard of care.
- On time delivery of work items as agreed timelines

- Local stakeholders kept abreast of evolving global/local CD strategy and clinical program execution status
- Risks/issues impacting CD strategy in Japan identified in a timely manner and appropriate actions and/or adjustments implemented involving the local/global stakeholders
- Built optimal communication paths with Clinical Development & Operation (CDO) function based on the operational format of CTs (Inhouse or Hybrid Outsourcing Model)

- Strategic insights fed into CD and regulatory strategy
- Strategic deployment of Key EE engagement to strengthen argumentation in HA interaction
- Provision of Japan input based on the insights generated
- Contribution to asset-centric, orchestrated EE engagement and insight generation with cross-function team

- PMDA consultation dossier and inquiry response delivered in alignment with asset strategy and with local/global stakeholders as appropriate
- Timely completion of 30-/14-day review of CT notification
- Japanese version of IB and its revisions are prepared according to the procedures and in agreed timeline

■Regulatory and / or Organisational Requirements:
- BI and international legal and compliance rules & regulations
- Knowledge of regulatory frameworks for Japan (e.g., J-GCP), including trial requirements for registration/approval, acceptance of RWE for regulatory decision making, standards for compliant communication of various types of evidence, etc.

■Job Complexity:
Work as a medical science lead in Japan (Early) Evidence Core Team and if applicable, delegated the role of early Evidence Lead in Japan.
Position holds a high level of complexity to balance data / information at hand with the various needs of internal and external stakeholders and the requirements to localize asset strategies without straying away from overall strategy. Further complexity arises from the need to stay well-informed about competitive assets & strategies and their implications of the own product profile and differentiation.

Interfaces:
Corporate Asset Team(s)/Evidence Network, Japan Asset Team/Evidence and Value Network, Therapeutic Area Leadership, Medicine Japan function Head / line managers, External Experts, Scientific Organisations, Industry Association, Patient Organisations

■Job Expertise:
A deep understanding of the functioning of drug development and commercialization within the pharmaceutical industry, relevant indication, key stakeholders, key competitors, solid experience in study design, data analysis and interpretation are required

A deep understanding of the functioning of drug development and commercialization within the pharmaceutical industry, relevant indication, key stakeholders, key competitors, solid experience in study design, data analysis and interpretation are required