Janssen R&D US is recruiting for a Scientific Alliance and Operations Manager, OTR (Asia Pacific)
for the Oncology Translational Research and Diagnostics team. The incumbent will assume responsibility for coordinating the execution of biomarker activities across a portfolio of translational research and diagnostic activities in China and Asia Pacific (APAC) region. The incumbent 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 and key collaborations with KOLs in the region. In addition to setting up CRO contracts and relationships with key test sites, he/she will be 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. Additional 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 for specific teams.
· 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.
· The incumbent is expected to 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.
· Accountable for 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
· Ability to effectively and collaboratively work on global cross-functional teams
· Minimum of a bachelor’s degree, master’s degree preferred
Required Experience and Skills
· 6-8 years of work experience
· Strong knowledge and understanding of clinical research, ICH GCP, GLP required
· Experience managing vendors and external partners
· Excellent written and verbal communication skills
· Strong understanding of sample operations logistics
Experience working in a matrix environment
J&J (China) Investments Ltd (7046)