About Us
Sanofi is an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives.

Job Purpose
The Japan Project Head (JPH) serves as the
project lead for priority assets
, holding comprehensive
accountability within the assigned therapeutic area (TA)
. This role encompasses end-to-end responsibilities,
from the early stages of development through to the product launch
. The JPH will act as the project owner, aligning development strategies at
both local and global
levels. This includes harmonizing efforts with
external stakeholders
such as patients, medical societies and health authorities.

Key Responsibilities

• Strategic Development Planning:

Develop a
strategic development plan
aligned with the Global Project Team (GPT) strategy and global financial cycle. Ensure the integration of Patients/PAG, Key Opinion Leader (KOL) and Health Authority (HA) engagement plans, as well into the operational plans. Ensure these strategies are adaptable to changing market conditions and regulatory requirements.

• Leadership and Collaboration:

Lead the
Japan Project Team (JPT) and co-lead the Japan Strategic Task Force (JSTF)
across all development phases. Ensure alignment of project goals and strategies with key stakeholders, including senior management, cross-functional teams, GPT, and external partners. Facilitate regular communication and updates to maintain transparency and support.

• Clinical Development Strategy:

Develop the clinical development strategy for Japan, including the clinical data package and clinical study protocol for local studies. Lead the decision-making process for the project, utilizing data-driven insights and scenario planning. Ensure that all decisions are documented and communicated effectively to relevant parties.

• Regulatory collaboration:

Write and review clinical sections of
regulatory documents
, such as briefing documents for PMDA/MHLW meetings, filing dossiers for JNDA, and responses to PMDA queries. In addition to collaborate related to submission and approval, consult and support scientific and clinical contributions for
health authority communications
. Execute appropriate communication with regulatory agencies (PMDA/MHLW). Ensure that all project activities comply with relevant regulatory requirements and industry standards.
Stay updated
on changes in regulations and
adjust
project strategies accordingly.

• Risk Management:

Identify potential
risks and opportunities
and develop mitigation strategies to address them. Propose
scenarios and decision trees
for endorsement. Regularly review and update risk management plans to ensure project continuity and success.

• Scientific Communication:

Author
clinical/scientific disclosures and publications
for local studies and sub-analyses (Japanese/Asia). Implement the
scientific communication plan
.

• Partnership Building and Early Launch Readiness:

Build strong, long-term partnerships with Patients/PAGs, KOLs and relevant medical societies as part of early launch readiness and excellence. The objectives of partnership include but not limited to early study/project planning, and clinical operations (feasibility and enrollment, investigator meetings, pls refer to the clinical trial support*), PMDA consultation, NDA submission, Q&A with PMDA. Ensure
end-to-end launch readiness and excellence
by collaborating with medical and commercial teams. Act as a
business owner
for development pipelines, focusing on patients/Patient Advocacy Groups (PAGs), KOLs, and medical societies.

• Process Efficiency and continuous improvement:

Promote
acceleration and efficiency
in processes related to global strategy, e.g. GSD, GSS, resourcing strategy, and capability enhancement (e.g. DriveDigital). Promote a culture of
continuous improvement
within the project team. Encourage the adoption of
best practices, innovative solutions, and new technologies
to enhance project outcomes.

• Market Insights:

Incorporate patient, KOLs, and market insights on unmet needs and the scientific/clinical value of compounds into development and submission processes through to launch.

• Resource Management:

Monitor the allocation and utilization of resources, including budget, personnel, and technology. Ensure that resources are used efficiently and effectively to achieve project goals.

• Reporting and Documentation:

Maintain comprehensive documentation of all project activities, decisions, and outcomes. Provide
regular reports
to senior management and other stakeholders to ensure
accountability and transparency
.

• Ambassadorship:

Serve as an ambassador for JP R&D
within and outside Sanofi
by participating in non-project
transversal initiatives
, whether affiliate/corporate-wide or community-driven.

• Clinical trial support: The Project Lead is responsible for providing comprehensive medical input and support for all activities related to clinical studies. This includes:
• Study Documents:

Offering medical expertise in the creation and review of study documents, ensuring accuracy and relevance.

• Medical Training:

Conducting medical training sessions for the study team to ensure they are well-informed about the study protocols and objectives.

• Feasibility Assessments:

Assisting in the feasibility assessments of clinical studies to determine the practicality and potential success of the study.

• Data Review and Study Reports:

Reviewing clinical data and contributing to the preparation of study reports, particularly for local studies.

• Medical Information:

Providing essential medical information to the study team, medical advisors, local study managers from Clinical Study Units, and investigators to support informed decision-making.

• Collaboration with Investigators:

Working closely with investigators to ensure they have the necessary medical support and information to conduct the study effectively.

Key Requirements

• Expertise and Experiences:
• Comprehensive Project Experience: Extensive experience in project leadership, clinical trial operations, creation of Clinical Study Reports (CSR), filing dossiers, and Japanese New Drug Applications (J-NDAs).
• Regulatory Milestone Preparation: Proven track record in leading the preparation for PMDA/MHLW milestone meetings, including Orphan Drug designation, preP-2, EoP-2, and pre-JNDA, addressing key strategic issues.
• Interdisciplinary Understanding: Excellent understanding of the interdependencies among various disciplines such as CMC, Pharmacology/Toxicology (Pharm/Tox), Pharmacokinetics (PK), Clinical, Regulatory, Marketing, and Finance.
• Industry Experience: Minimum of 10 years of experience in drug development within the pharmaceutical, biopharmaceutical, or biotechnology sectors. Crossfunctional work experience including medical and commercial is highly preferred
• Therapeutic Area Expertise: Experience across multiple therapeutic areas, with a preference for immunology-oncology.
• Language Proficiency: Fluency in written and spoken Japanese and English.
• Digital projects experience are highly preferred
• Skills and Competencies:
• Influence in a Matrix Setting: Demonstrated ability to effectively communicate, influence, and lead within a matrix organizational structure.
• Collaborative Communication: Strong collaborative skills with excellent communication and negotiation abilities.
• Risk Management and Governance: Proficient knowledge and sense for risk management and governance practices.
• Performance and Outcome-Driven: Focused on achieving performance metrics and driving outcomes.
• Business/Finance Acumen and Strategic Capability: Fundamental understanding of business principles and strategic thinking.
• Innovative Mindset: Possesses scientific curiosity, logical and analytical thinking, and an innovative approach to problem-solving.
• Digital literacy: the ability to effectively and critically navigate, evaluate, and create information using a range of digital technologies. This includes, technical proficiency, information literacy, communication skills, critical thinking, and safety and security.
• Education and Qualifications:
• Bachelor's Degree: A bachelor's degree or equivalent in life sciences or a related field is required.
• Advanced Degrees Preferred: Holders of a master's degree, PhD, or MD are highly preferable.
• Having clinical experience in a local medical/clinical setting is highly preferable

Equal Opportunity Statement
Progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at

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