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Scientific Associate Director, Clinical Pharmacology Lead Japan

Scientific Associate Director, Clinical Pharmacology (CP) Lead Japan position in Quantitative Pharmacology within the broader Clinical Measurement Sciences (CMS) organization is a strategic, scientific, and cross-functional role.  The Clinical Pharmacology Lead Japan ensures the Japan CP strategy, including model-informed drug discovery and development (MiDDD), is developed, endorsed and executed, aiming to develop the next medicine with the right dose (level, regimen and adjustments with different conditions and specific populations) and right drug combination for the right patient population and to provide health authorities and prescribers with appropriate information.  The scope includes programs from Phase 1 through life cycle management, encompassing large and small molecule therapeutics/drug candidates across different therapeutic areas. This role participates relevant workstreams at the Clinical Pharmacology Expert Team (CPET), as well as providing integrated team input to the Global Project Team (GPT) and/or local Japan team and leading/participating in highly interactive discussions at both levels. This role requires a sense of urgency with a strong can-do attitude in identifying and driving the debate around key issues while keeping the big picture and long-term targets in mind. Therefore, it is vital for this individual to have a broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities.

KEY ACCOUNTABILITIES

 

Ensures that Japan CP strategy is developed, aligned (with cross-functional development plans), endorsed and executed with studies scheduled in a cost-effective manner to support the indication, patient population, and phase of development while taking into account the competitive landscape Ensures that he/she attends to regular CP Expert Team meetings, minutes confirmed, and decisions / recommendations communicated to line management and the Program Lead or Manager (PgL/PgM) or GPT , and the local Japan team Deliver a cross-functionally aligned FIH study and plan considering inputs from subject matter experts (SMEs) from other function lines. Supports CP expert team to deliver PK/PD related assessment schedules, and the immunogenicity assessment schedule in the protocols The strategy for concentration-QTc evaluation and immunogenicity risk assessments Relevant data flow from design, to data acquisition, reconciliation, analysis, interpretation, and to the presentation to SMC, project team and governance bodies. PK-PD based go/no-go criteria CP related scientific aspects for the governance bodies Cross-functionally aligned input to inform dose and posology decisions, from FIH starting dose through Launch and beyond The delivery of fit-for-purpose CP package including dose, dose regimen, and adjustment for specific conditions (DDI, food effect) and specific populations (pediatrics, geriatrics, organ impaired, ethnic populations, etc), exposure-QTc assessment and immunogenicity assessment in collaboration with other function lines at appropriate stages of development The preparation of CP related section of major clinical and regulatory documents (clinical protocols, IBs, CTDs, INDs, NDAs, IMPDs, briefing books, etc.) and oversighting the Japanese translation Consistency and alignment of key content and overall flow of CP related eCTD modules (2.7.1 and 2.7.2) with other modules (1, 2 and 5) in particular Section 1.14 Labeling, 1.16 Risk Management Plan, 2.4 Nonclinical Overview, 2.5 Clinical Overview, 2.6.4 Pharmacokinetics Written Summary, 2.6.5 Pharmacokinetics Tabulated Summary and 2.7.3 Summary of Clinical Efficacy and 2.7.4 Summary of Clinical Safety , and adapts the above documents for NDA/sNDA submissions in Japan The cross-functional responses to health authority ‘requests for information’ concerning the CP scientific areas In-depth CP, PK and PK/PD advice and expertise to support relevant local Medical Affairs (MA) studies with CP components such as dosing strategies, drug- interaction potential and exposure-response/safety analysis in close collaboration with CPET, the respective clinical functions and study teams Involvement of Japan/China in the CP strategy Interacts with the leader from CMS biomarker expert team to represent a unified view from CMS aiming at selecting right dose, right combination and right population May need to contribute to the in-licensing due diligence if needed EDUCATION/LANGUAGES3+ years (Bio)pharmaceutical industry and/or postdoctoral experiences with clinical drug development experience Doctorate degree (PhD, PharmD or MD) relevant in the related disciplines of clinical pharmacology, pharmaceutics, pharmacometrics, statistics, engineering or mathematicsFluency in EnglishPROFESSIONAL SKILLS & EXPERIENCEStrong understanding of clinical drug development strategies, and quality related requirements in drug development in GXP-related areas. Deep knowledge in CP, i.e., PK, ADME, posology, quantitative translational sciences, etc.Excellent knowledge of regulatory requirements and submission across the main regionsGood understanding about translational sciences such as quantitative pharmacology, safety and biomarkers.Clear evidence of ability to adapt to changing business needs by prioritizing multiple tasks.General knowledge of oncology, immuno-oncology, and/or immunology, and more in depth understanding of biology and pharmacology is a plus.Hands on modeling expertise is a plus.Strong interpersonal skills and proactivity to cultivate a network of productive relationships in an international matrix environment.Demonstrated ability for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results.Strong presentation, communication, and organization skills. Ability to communicate technical results to stakeholders.have a broad scientific understanding across the translational sciences and drug development along with excellent team-building skills and strong collaborative & strategic capabilities.

 

 

 

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