Translational Science / Translational Medicine and BM Lead

面议

上海市

刷新时间：2024-02-18

职位描述

The incumbent will lead/represent the Translational Science (TS)/Translational Medicine (TM) and Biomarker (BM) Development functions and report directly to the CSO (at the interim). In collaboration with multi-disciplinary R&D teams the incumbent is responsible for developing and implementing BM strategies to meet program needs across a diverse portfolio of drug development and help advance R&D pipeline through the identification of biomarkers of disease, predict clinical response to therapy (based on mechanism of action), and identify patients enrichment studies with the following duties:
·Lead the strategic planning and execution for indication-specific BM identification,development and application, Clinical Trial Assay (CTA) and Companion Diagnostic (CDx) development to support all phases of drug development, including
Validate target engagement
Plan/execute pre-clinical PD BM experiments, analyze and interpret data
Plan and execute BM/CTA/CDx studies for all clinical trials relevant to MoA, PD, patient selection/stratification, predicting responses, and monitoring relapse and/or minimal residual diseases, and surrogates for clinical end points
·Serve as the primary contact for all BM, TS/TM and CDx functions for all R&D programs.
Advise project teams on BM/CTA/CDx strategies, including preclinical PD BM and clinical PD BM/CTA/CDx development, validations and applications, assessment of developtability and PoS
Define performance criteria for PD BM/CTA/CDx assays per the scientific relevance, regulatory and clinical requirements and lead the PD BM/CTA/CDx assay performance assessment.
Responsible for the assessment, selection and qualification of CROs/partners (including In vitro Diagnostic (IVD) companies) for any outsourcing BM assay, CTA and CDx activities. Develop and implement CRO/partner qualification process including regular proficiency testing.
Review and assess CRO’s and/or partners’ BM, CTA and CDx development and validation plans, and verify the analytical validation results.
Draft and/or review and execute BM/CTA/CDx study protocols and contracts, manage CRO / partners.
Analyze and interpret BM, CTA and CDx data, assess its validity, drive PD BM and CDX discussions, facilitate trouble shooting for any issues related to the assay results, and ensure data-driven decisions for all R&D programs.
Collaborate with internal and external stake holders for sample management (including sample collection, processing, and storage for pre-clinical animal samples and clinical samples), and coordinating activities for biomarker/PD assay, CTA and CDx implementation for clinical trials, data analysis and final reports.
Evaluate BMs and the associated assay platform technologies and the BM / CTA/ CDx assays regarding their scientific basis, technical feasibility, performance characteristics and clinical applicability.
·Support drug target selection and landscape: Serve as the Translational Science and BM/CDx subject matter expertise in the evaluation of experimental design and data interpretation related to new drug targets.
·Contribute to submissions to regulatory agencies: Author sections of clinical trial protocols, clinical study reports, informed consents relevant to biomarker/CTA/CDx, and support submissions to regulatory agencies.
·Support BD activities including technical due diligence: Serve as the Translational Science and BM/CTA/CDx subject matter expertise in the evaluation of experimental design and data interpretation related to BM validity and CTA/CDx feasibility.

Qualifications

·PhD degree in Molecular Biology, Life Science, or related discipline, with 8+ years combined direct experience in TS/TM/BM/x functional roles from preclinical to all phases of clinical development.
Formulating/executing pre-clinical TE/PD BM development strategies.
Formulating/executing clinical PD BM / CTA / CDx development strategies.
Designing, leading BM qualification, BM assay, CTA/CDx development and validation, and BM/CTA/CDx implementations in clinical trials
·In-depth knowledge of various BM assay platform technologies (e.g., NGS, qPCR, FISH, IHC, etc.) and with a proven ability to delineate the impact of different technologies on the performance of BM/CTA/CDx assays and on clinical study designs, study outcomes and timelines, and the overall probability of success.
·Practical experience in BM development and BM/CTA assay development including experimental design, assessment of assay performance, analytical validations, and troubleshooting of any data issues.
·Deep understanding of drug discovery and development and applicable regulatory requirements, and comprehensive knowledge of how BM/CTA/CDx contribute to successful drug development.
·Hands-on direct experience in implementing BM assays, CTA or CDx in phase 1 – 3 clinical trials and/or regulatory approval is highly desirable.
·Excellent interpersonal skills, and ability to work in cross-functional teams and strong scientific leadership skills.
·Can-do attitude with ability to adapt and meet timelines and budget targets.

其他要求

招聘人数：1人
职能类别：研发总监/研究院院长

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。