Johnson & Johnson Careers
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Senior manager, Early Development
Requisition ID: 1805622060W
· As SRP and early Clinical Lead
o Responsible for the strategic and operational translational medicine input to the design, planning, initiation and completion of early phase clinical trials( from ph1 to Ph2a studies);
o Support Ph0 project Leader in the management and implementation of Translational Medicine strategy to facilitate the rapid and effective bridging of results in the research laboratory to patients in clinical studies;
o Provide medical and scientific expertise on the use of novel biomarkers and potential companion diagnostic tests for the commercial strategy of the company projects.
o Responsible for composing and communicating of key clinical assumptions, risks and mitigation strategies by study/project;
o Provides input to publication strategy for the projects/products. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals;
o Leads and/or participates in clinical/medical advisory panels, steering committees and investigator meetings.
· If also as an eCCTL,
o Leads the early China Compound Team (eCCT) to successfully develop the compound development strategy;
o Act as primary point of contact with CDT, CTASTe, TA/DAS leadership and Sr. Management for all project status information and budget updates. Leads the communication of strategy, issues, and plans withCDT, CTASTe, the governance committees (/CDRB/APDMC/ORB, etc.), and other key stakeholders and obtain corresponding alignment/approval of CCT proposals;
o Leads decision-making by the CCT, including the potential of making final decision when full consensus cannot be reached (but not against a majority vote). Identifies potential issues and leads contingency planning and problem-solving by applying appropriate analytical tools and techniques.
A. 教育程度Education:(学历及专业/Diploma, Degree and Major)
M.D. w/wo Ph.D.; M.D. is mandatory
B. 工作经验Working Experiences:
- 2-5 year or more clinical practice experience in hospital;
- At least 5 years physician experience (in Medical Affairs and/or Clinical development, Clinical development is preferred; at least 8 year for AD level)in pharmaceutical companies are required;
- Experience of leading studies/projects/compound-development within a global multi-functional R&D matrix organization is desirable.
C. 知识/技能Professional Knowledge/Skills:(包括计算机、外语技能/Including computer & language skill)
· A quick learner to new Medical and/or Scientific mechanism;
· Thorough knowledge of drug development process and familiarity with pharmaceutical portfolio risk management is required for AD level;
· Fluent in both Chinese and English;· Thoroughly understand and command Health Care Compliance.
· Solid medical knowledge to provide scientific and/or medical judgment/input to study team and or compound development team;
· Good oral/written communication skills, allowing effective interactions with all levels of the study team and organization.
· Very strong interpersonal skills to bridge scientific and business participants for negotiating timelines, resources and effective international collaborations (especially for AD level).
B. 领导力Leadership Competencies:
· Demonstrated ability for comprehensive thinking and contingency planning for study design, execution and report is strongly desired;
· Demonstrated strong leadership, influence, negotiation and conflict resolution skills, including the ability to influence and align without clear reporting authority are strongly desired for AD level.
J&J (China) Investments Ltd (7046)
Clinical Research MD