1、The Senior Clinical Biomarker Leader will be responsible for leading the clinical biomarker development strategies, execution and budgetary planning for oncology immunotherapy Projects;
2、Leads early and late development programs and ensures the drug products enter clinical development with testable hypotheses and fit-for-purpose biomarker assays as part of the development process;
3、Develops distinctive biomarker plans to support oncology immunotherapy differentiation development strategies and leads design, validation, regulatory submission and approval of CDx development independently and self-responsibly;
4、Drafts biomarker sections in clinical protocols, CSRs, regulatory reports, briefing books and other submission documents to support INDs, closure, clinical narratives, reporting and filling of the studies with a strong strategic and analytical focus based on knowledge of drug, disease area and relevant science in order to meet regulatory and disease strategy targets;
5、Works collaboratively across the functional teams, including medical leaders,
translational scientists, toxicologists, clinical pharmacologists, drug safety specialists, as well as personnel from other support functions and strategically influence the use of biomarkers for decision making purposes from early development through pivotal clinical Studies;
6、Partners with operational colleagues to support executional delivery of biomarker test, sample collection, storage and shipping and ensures that all activities are conducted in compliance with relevant regulatory requirements;
7、Independently analyzes, interprets and presents results from biomarker analyses, draws scientifically valid conclusions that support decision making and be accountable for biomarker integrated scientific reports and peer-reviewed publications for clinical trial results;
8、Holds responsibility for site interactions in partnership with the study managers for biomarker questions and site trainings;
9、Identifies and builds relationships with investigators, KOLs in drug development to gain their inputs on emerging science in biomarker research, disease knowledge, and design of precision medicine development;
10、Serves as biomarker point of expertise internally and externally with Health Authority interactions, ethics committees and advisory board meetings.

1．A PhD, PharmD or MD equivalent degree in Clinical Pharmacology, Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline with significant modeling-related content and 10+ years relevant work experience in clinical drug development;
2．Excellent knowledge of phase I-3 clinical design, operation, drug development, global study regulatory requirements and PK/PD analysis and industry experience in applications of basic research and translational medicine in clinical design and execution;
3．Excellent experience with quantitative approaches, modeling and simulation in drug development, and working knowledge of relevant modeling software such as NONMEM, WinNonlin, R, SimCYP, and GastroPlus is desired;
4．Knowledge of the latest developments in clinical pharmacology, proof-of-concept investigation and guidance documents and evidence of hands-on experience in the application of pharmacometrics methods to drug development;
5．Strong ability to perform PK/PD data analyses, interpret clinical data and their relation to the clinical setting and able to handle multiple clinical pharmacology programs simultaneously;
6．Drug development experience in one or more therapeutic areas with working knowledge of clinical and regulatory landscape, patient populations, disease mechanisms, treatment paradigms, and competitive landscapes;
7．Strong track record of publications and able to apply scientific knowledge to the company's products, identify issues, apply insightful analysis, and solve problems effectively;
8．Strong consulting skills in the drug development context within internal function teams, external experts and working experience interacting with regulatory agencies;
9．Excellent presentation skills to a wide range of target audiences, including, but not limited to cross-functional teams, academic conferences and with regulatory meetings;
10．Capability to lead across diverse cultures with flexibility to work with global teams in different time zones;
11．Fluent in English (oral and written) is desired.

 

 

1、The Senior Medical Writer will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities, including but not limited to study protocols, patient informed consents, interim and final clinical study reports, safety update reports, investigator brochures, and slides for internal and external presentations.
2、Conduct comprehensive literature searches to enhance their background understanding, then evaluate, analyze, and apply to clinical documents.
3、Achieve company regulatory, clinical, operational, and marketing goals and ensure the regulatory documents that he/she prepares must meet ICH, GLPs, and GCPs guidelines.
4、Review and edit documents for completeness, clarity, consistency and conformance to corporate SOPs to ensure all data and information is accurate and verifiable against source documents to confirm compliance and traceability.
5、Manage document development timelines to facilitate timely submission.
6、Attend internal/external meetings and prepare the meeting documents and meeting minutes.
7、Prepare the manuscripts for medical publications in peer-reviewed journals.
8、 Contribute to writing and updating corporate SOPs, work instructions, or policies.
9、Participates in documents QC, GCP Audits and Inspections.
10、Support other functions that need medical writing support.