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A Chinese biotech company who has their own technical platform and discovery team, with world-famous funding at their back. They are now seeking for an executive-level candidate to lead the entire Clinical Development function and to be involved in the strategy of their business development globally.
· Highly engaged in the strategy making & development plan for the company · Lead company portfolio review and strategic planning activities · Prepare clinical development plans, target profile and budgets for potential first market entry opportunity of high-profile products. · Set up and build the clinical development team composed of clinical research physicians, clinical operation, pharmacovigilance, etc.
· Strong medical and scientific background with an in-depth understanding of global/ China clinical regulations and guidelines. · Detailed working knowledge and hands-on experience of clinical study design and clinical study reports. · The experience in leading overall clinical development programs, clinical study protocol development, etc. · Entrepreneurship, willing to embrace new challenges and set up new things from scratch.
Please send your CV to info@tal-gene.com
A rising Chinese biotech company that has strong pipeline & product portfolio. They have accomplished stage success with the products they licensed in. They also have licensed out self-innovate product to a multinational pharmaceutical company, which has the best evidence on their innovation capability. They have sites in both China and the U.S. They are now seeking for a Clinical Science Head, level from Sr Director to Vice President for their star product in detecting the indications in Hematology/ Solid Tumor/ Immu-Oncology.
· Oversee and review programs to assure that best practice and innovative methods are being employed optimally to deliver differentiated patient solutions most effectively with best use of resources. · Recruit, train and develop a team to ensure optimal design and delivery of studies and programs in an effective manner. · Provide conjoint, authoritative and aligned guidance between all functional heads on matters related to GCP, SOPs and training implementation
· Clinical Medicine background in Hematology/ Solid Tumor/ Immu-Oncology with an in-depth understanding of global/China clinical regulations and guidelines, and experience in developing strategies based on emerging regulatory knowledge · Substantial Clinical Development experience ideally with a blend of pre-NDA and post approval study work and major regulatory agency interaction, particularly in China. · Experience in working within matrix teams with evidence of success in co-creating and implementing innovative governance programs and externally focused development solutions.
Please send your CV to info@tal-gene.com
This biotech company is scaled 80-100 people in China. The company’s pipelines cover specialty drugs, gene therapy and consumption medical device. Their dugs are under the clinical development plan into Southeast Asia, Australia and the U.S., and soon the first product will go to the market.
As a strategic leader within R&D organization and key partner to the Development function leaders, maintain a big-picture view of R&D, drive development & execution of the Integrated Development Plan and enable the Development Operation excellence.
· In depth knowledge of pharmaceutical R&D process including strategic and operational aspects. · A strong track record of coordinating or managing the delivery of a R&D portfolio within specified timeframes. · Demonstrated capability to source relevant organizational information to understand future R&D project needs and preempt potential project risks, issues and challenges. · Previous delivery of strategic advice and support to senior management. · Demonstrated ability to handle complex efforts and work independently while also collaborating with cross-functional teams.
Please send your CV to info@tal-gene.com
Our client has a full clinical CRO business with Central Lab, Clinical Operation, SMO, etc. service in China. The company has been developed as times of the scale when it first came to the business in China. And now it has been acquired by a global CRO company. They are seeking for a Clinical QA functional leader in China reporting to the Global.
· Provides clear functional direction and quality strategy as well as expectations to ensure each CQA staff member in China understands her/his responsibilities to know and follow all SOPs and corporate policies. · Ensures client audits and regulatory inspections of the CRO are prepared and managed (hosted) to meet the client’s/inspectors’ requirements and minimize disruptions to ongoing operations. · Ensures training is provided to new/ old QA employees and contributes to training for selected Clinical functional groups related to GCP, clinical trials regulations. Ensures CQA staff in the China team under their direction effectively executes the CQA Operating Plan, including the annual audit plan.
· More than 10 years’ experience in a large pharma or CRO of clinical service, with more than 5 years in clinical quality function and more than 2 years’ people manager’s experience. · In-depth knowledge of ICH, GCP, local regulations and guidelines. · Relevant experience in clinical QA & audit is preferred. · Competent in written and oral English.
Please send your CV to info@tal-gene.com
