Johnson & Johnson Careers

Associate Director, Scientific Alliance and Operations, OTR (Asia Pacific)

Shanghai, China
Biology


Job Description

Requisition ID: 1905773364W

Janssen R&D US is recruiting for an Associate Director, Scientific Alliance and Operations, OTR (Asia Pacific) for the Oncology Translational Research and Diagnostics team.  The incumbent will assume responsibility for coordinating the execution of biomarker activities across the portfolio of translational research and diagnostic activities in China and Asia Pacific (APAC) region, through leadership of a local scientific operations management team. The Associate Director  and team will work closely in coordination with OTR scientists and Clinical teams across Oncology Development in China and, where necessary with counterparts in the global TR organization, including the Global TR Operations to implement and execute OTR programs in clinical studies. In addition to setting up CRO contracts and relationships with key test sites, the team is responsible for ensuring efficient execution of sample logistics, execution of assays according to validated requirements and transfer of data to the Translational Team Leader or Disease TR Leader according to agreed timelines. Additionally, the team’s responsibilities will include design, implementation and management the alliance management for oncology KOLs and CROs and clinical sites in China and APAC, including setting up contracts and ensuring all deliverables are met for each relationship. The Associate Director is accountable for establishing this capability in China/APAC and alignment with best practices across the global organization. The incumbent is also accountable for management of resources and budgets for the China TR organization. Additionally, to ensure success of the Scientific Operations team, the incumbent will develop strong relationships and conduct outreach activities with key stakeholders e.g. KOLs, thought Leaders, regulatory authorities in China and APAC region to further translational research and diagnostic development business goals.   

 

Key Responsibilities

·        Provide biomarker operational direction and leadership for clinical programs in the Oncology TA to ensure the delivery of biomarker activities are aligned with the biomarker strategy and clinical study timelines

·        Responsible for scenario planning, high level forecasting of timelines, assessment of program level feasibility and estimation of budget and resources

·        Maintain an overview of status and issues and proactively communicate progress, challenges or changes that may impact timelines to the global team

·        May recruit, manage and provide leadership, strategic direction for new staff

·        Maintain strategic-level alliance relationships with key vendors in the region

·        Effectively and collaboratively work on global cross-functional teams

·        Build and foster strong relationships and conduct outreach activities with key stakeholders e.g. KOLs, thought leaders, regulatory authorities in China (and APAC, as required) in order to effectively progress translational research and diagnostics business goals

·        Line manager of OTR/Dx Clinical Operations Specialists

·        In addition to above responsibilities, incumbent may be required to conduct OTR/Dx Clinical Operations Specialists activities, these include:

·        Serve as the point person for clinical studies, TR disease strategies or assay validation conducted in China (and the Asia Pacific region where necessary) for TR operations, aligning with the Global team to enable seamless operations of the TR plan in Chinese studies.

·        Identify CRO’s or Clinical Investigators in China who can perform the necessary assays, provide samples for clinical studies, TR disease strategies or assay validation consistent with the requirements of the Global TR team.

·        Work effectively with procurement to set up necessary contracts, statements of work and proactively ensure that work conducted in China (and APAC) is appropriately budgeted, manage the budget and oversee the delivery of contract milestones by the vendor or collaborator.

·        Biomarker sample management including oversight of CROs and or collaborators to ensure samples are collected as required from studies consistent with quality, timeliness and tracking. The incumbent is expected to ensure that samples are provided to CROs from clinical sites or collaborators, data generated and made to computational teams and or TR leads in China as outlined in the SOW, protocol or other translational plans

·        Contribute to the preparation of clinical documents such as protocols, clinical study reports, lab manuals, informed consent forms, sample management plan, early development plans and training

·        Develop presentations for status updates, program approval meetings and investigator meetings, as required

·        Working under direction of the biomarker lead, evaluate and implement new assays and relevant technology as required by the program

·        Implement the OTR/Dx alliance management structure for key vendors as directed by OTR/Dx leadership

·        Manage relationships with key vendors to ensure on time and quality deliverables, as contacted

·        Act as a “single point of contact” for key vendors



Qualifications

Education

·        Master’s degree preferred

Required Experience and Skills

·        10 years of work experience

·        Strong knowledge and understanding of clinical research, ICH GCP, GLP required

·        Line management experience required

·        Extensive experience in working on global, matrixed teams, required

·        Ability to develop and maintain strong relationships with internal and external stakeholders

·        Experience managing vendors and external partners

·        Excellent written and verbal communication skills

·        Strong understanding of sample operations logistics required

·        Good understanding of human physiology, pharmacology and biomarkers

·        Experience working in a matrix environment



Primary Location
China-Shanghai-Shanghai-
Organization
J&J (China) Investments Ltd (7046)
Job Function
Biology
Requisition ID
1905773364W