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- Proprietary bi-targeting XDC technology platform
- Biotechnology experts team
About Our Client
Established in 2016, the company is dedicated to R&D and commercialization of bi-targeting XDC drugs. The management team of the Company consists of numerous experts in biotechnology R&D, medicinal chemistry/CMC, clinical study, and business development, including two enlisted in major national talent programs, one high-level expert in innovation and entrepreneurship of Jiangsu Province, all of whom are industrial veterans in global drug development.
Their proprietary bi-targeting XDC technology platform includes PROTAC Platform and Chronic Diseases Platform. With the possibility to actively and cell/tissue specifically deliver any bioactive molecule, bi-targeting XDC technology has the potential to overcome the undruggability obstacle of a variety of molecules with high bioactivity, thus to Drug the Undruggable, and pioneer a new pathway of drug development.
The pipeline of the company is not only limited to the field of oncology, but also covers other areas including multiple chronic diseases by tissue/organ site-specific targeting. Currently, multiple pipeline projects have entered into global development stage.
- Direct the development of clinical strategies and plans to integrate company compounds into the standard practice
- Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities (CDE and FDA)
- Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
- Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders
- Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy
- Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners
- In addition to managing and supervising the Clinical Research Department the CMO will have direct line responsibility for the Clinical Operations, Patient Advocacy, Medical Affairs, and Biometrics Departments
- Must have a results-oriented work ethic and a positive, can-do attitude. Effective leadership, people management, communication skills and a team builder management style are essential; must be willing and able to be "hands on"
- Must demonstrate personal values and ethical standards
The Successful Applicant
- Knowledge of relevant FDA and CDE regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA and CDE personnel is essential; experience in interactions with other health authorities a plus
- Experience with, or strong knowledge of Oncology drug development
- Experience or knowledge of oncology IND and NDA submissions
- Experience in translational medicine, clinical pharmacology and early stage development is desirable
- Excellent knowledge of the competitive environment for drugs in the Hematology/Oncology marketplace and in research and development pipelines
- Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines
- The successful candidate will read, write and speak fluent English, possess excellent communication skills and will be capable of articulating the Company's clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor community
- Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence
- Must be science- and data-driven
- Ability and strong desire to "make things happen"
What's on Offer
You will offered competitive salary package along with the opportunity to contribute to the company scientific advancements and long-term development
- Life Sciences
- Contract type
- Consultant name
- Maria Karp
- Job reference