Medical Advisor

Medical Advisor

Grade: L3

Hiring Manager: Kentaro Obara, Head of Japan Clinical Operations, R&D

Location: Japan, Tokyo, 50% Remote working

Job type: Permanent

About the job

Medical Advisors provide medical and scientific expertise and guidance to investigators and CSU (Clinical Study Unit staff performing clinical trials within a CSU cluster to ensure patient safety and scientific integrity of the protocol which ensures the reliability of information provided to agencies at submission. They are therapeutically aligned medical experts in the country/region for the studies/projects they are responsible for. They provide appropriate medical and scientific feedback to Local CSU operations teams as well as global R&D Medical Operations, i.e., Clinical Research Director (CRD), Global Feasibility Lead (GFL), TA early planning leads, global project team, pharmacovigilance, and regulatory affairs. They ensure the medical and scientific collaboration with medical functions in the respective Business Units in the countries of their responsibility and with investigators, trialists, medical experts, and Key Opinion Leaders (KOLs) in the country, region, or global level.

Responsibilities

Provide medical/scientific value across a continuum of both external and internal stakeholders: e.g., Key external experts and other healthcare professionals within assigned therapy area or assigned programs, (potential) investigators, professional societies, and patient organizations.

Review and resolve local medical issues / questions that arise during the entire course of the study and that arise from local regulatory authorities – if necessary, transferring issues to global teams.

Proactively seek and collect the medical voice of the external experts, potential investigators and KOLs to facilitate the conduct of clinical trials. Through appropriate scientific exchange and scientific engagement with external stakeholders, secure advice that informs and assists internal strategic functions in the development of compounds.

Act as the local medical expert to bring early input into study design and operational aspects.

Provides timely medical training to local Monitoring Team, including training to CSU staff on protocols, therapeutic area, disease, products, medical environment, medical and/or scientific training to new hires.

Provides medical and scientific advises to key internal stakeholders developing proposals: this may include, but is not limited to, reviewing the protocol for scientific/regulatory soundness and feasibility, providing medical/scientific insights on target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.

Exchange information between R&D and other departments within the affiliate and contribute to Medical Department Team meetings related to the therapeutic area to ensure objectives of these meetings are met.

Local scientific knowledge and lobbying allowing capture of country specific information on competitive intelligence and validation of global hypothesis from the Clinical Development Plan or assessment of Extended Synopsis (ES)/protocol contents.

Liaise with local Medical Leads within Sanofi Global Business Units in his /her country(ies) to manage investigators and compounds.

Support local/regional Investigator Meetings regarding medical content and interaction with investigators in collaboration with CRD.

Ensure accuracy of translation of medical terms related to study documents when translated into the local language, including ICF, patient materials, wherever appropriate.

Contribution to protocol optimization and standard of care assessment as a part of Pressure Test to position the study in the ecosystem and drive local strategy.

Patient Network Engagement at local / regional level, being the link to Patient Informed Development & Health Value Translation Team.

Collaborate with TA Lead providing impactful and relevant local information to support the Global Strategy per TA including information to support diverse study population.

Knowledge And Skills

• Intermediate Risk Management Skills: Proactively measure & assess/map risk triggers (Risks-Probability-Impact): Threats & Opportunities
• Intermediate Project Management Skills: Stakeholder management & time management when planning projects
• Intermediate Data Analytics (& Digital): uses the systems, to read analyze and generate reports, in daily work.
• At least advanced Medical/Scientific Background-TA/Disease knowledge: Able to address scientific topics related to our products & disease. Understanding of the intersection of medical knowledge to help Clinical Operations
• Advanced Clinical Development Process: Understands product life cycle management and provides necessary support to the internal key stakeholders (GBU, PV, Regulatory, Public Affairs, Market Access)
• Advanced Problem Solving: Applies critical thinking to strategize ways of solving a problem
• Advanced Business Acumen (Business Sense): Keep Sanofi and Sanofi R&D strategic goals, growth, and profitability drivers in mind
• Advanced Change Management: Reinforces the change as enlarged cluster manager team members
• Advanced Emotional Intelligence/ good behavior: Strives to integrate emotional awareness, self-management and social skills in daily activities to manage relationships effectively.
• Advanced Interpersonal & Relationship Management: Influences, inspires and encourages people to think in a certain direction whilst acknowledging their opinions
• Foundational Develop People & Lead Teams: Understands the day-to-day and tasks required to manage people. Is regularly able to demonstrate 3 of the essential qualities of People Management. For example, is regularly developing SMART performance objectives with the team.
• Presentation skills: Able to present in front of local stakeholders and customers as well as a diverse external audience

Formal Education And/or Experience Required:

• Advanced degree (MD, PharmD, PhD in life science or equivalence)
• Knowledge of ICH, GCP and local regulations
• Fluent in English

Knowledge And Skills Desirable but Not Essential:

• MD degree is preferred
• Qualification in a medical specialization would be preferred but not required
• Previous experience in Clinical Practice, Clinical Research and/or Drug Development is a plus

Next Career

Global Feasibility Lead: Manage the feasibility studies at global level

Japan Project Lead: Leading local development project and responsible for regulatory submission and approval.

Clinical Research Director: Build and manage the global study protocol as a member of Global Project Team (MD degree is necessary)

Others:  Medical Manager, Medical Science Liaison in Medical Division etc.