Head of Scientific Operations 上市后临床研究负责人
Your tasks and responsibilities
1.Overall accountability for planning, executing and monitoring company sponsored studies through its overall process: from trial-feasibility to database lock, and ensure audit/inspection-readiness for all PMS in country, including IPAT and NIS study. The role is also accountable for investigator initiated research management. Contribute in study strategy making with solid knowledge and expertise.
2.Fulfil CFDA's requirement on PAC(post authorization commitment)study to support New Drug Approval and license renewal. Involve deeply in the study strategy making and insure successful execution. Cooperate well with other stakeholders, including TA, PV, RA, GPM, GPT. Delivery the study with high qualityand within the timeline to meet regulatory purpose and good result in inspection.
3.Develop and maintain integrated study review charter, the local MA cross function study review platform, to insure the local governance on the concept and protocol quality. Responsible for the smooth operation of this platform.
4.Ensure China scientific operations team objectives are met by overseeing key performance indicators to track progress, efficiencies and cost effectiveness, in conformanceto all relevant ICH-GCP regulations, guidelines, and internal SOPs, Work Instructions, and Policies. Identifies process improvement opportunity, share best
practices with global non-interventional study team to continuously improve global practices and eliminate redundancies.
5.Supervise on PMS budget & cost in line with organization requirement, coordinating with TAs and controller to ensure budget/cost meet the planned targets.
6.Be accountable for the planning and execution of system and process improvement initiatives. Leads and/or contributes to the design, development and evaluation of the Clinical Operations processes and standards to improve the clinical trial management. Ensure rollout of new procedures. Demonstrates Leadership in alignment with Leadership Initiatives.
7.Manage SO team, approximately 20 people including subordinates. Identify and develop high potential/team talents. Evaluate overall resource needs, and liaise with MC&DG Head for resource requests as appropriate.
8.Interact with Medical Therapeutic Area, Medical compliance, Pharmacovigilance, Legal, Controlling, Plant, Purchasing, Global medical affairs operation and coordination, global clinical supply, R&D, to ensure local business needs and timelines are met. Strategically evaluate vender (i.e., CRO, SMO) needs and selection to
support successful project execution and leverage expertise.
1.Bachelor's degree or above in Medical/ Pharmaceutics
2.More than 10 years working experience in pharmaceutical industry, solid relevant professional experience in Medical Affairs in multinational pharmaceutical company, and above 4 years people management experience.
3.Fluent professional medical and business Chinese and English for communication with Bayer HQ, local authority and experts
4.Strong analytical and communication skills with a clear understanding of both the customer and the marketplace
5.Highly motivated individuals to identify opportunities and work with external customers
6.Role model of integrity for group in complying with related laws, regulations and SOPs
Functional Area: [sap_fa_16]
Entry Level: 5