Chief Medical Officer - TIL Cell Therapy - Solid tumours
Breakthrough in cell therapy for Solid tumour patients
Dymanic science focused team
About Our Client
Our client is Chinese biotech with global routes. Launched by a team of the overseas returnee scientists and track record in Cell therapy research and IND application, our client is now looking for Chief Medical Officer to join their China operations.
Currently at Investigator Initiated Trial (IIT) stage and 4+ assets in the pipeline, the expect to reach Phase I in Q1 2021 for China trials and accelerated CDE and FDA submission.
- Plan and develop the clinical development strategies for from First-In-Human to Phase I-IV programs first in China and later on Globаl Level
- Develop clinical strategies and implementation plans, in partnership with both internal and external resources to achieve the company's strategic and tactical goals/objectives
- Provide hands on leadership to the entire R&D team, including but not limited to clinical, regulatory, research, etc. for the successful planning and execution of each clinical trial
- Support all clinical aspects of implementing and overseeing all relative clinical studies for drug development
- Manage activities of the CRO in conjunction with other members of the team
- Ensure that the company's clinical team fully adheres to good clinical practice
- Work with CRA's, clinical pharmacologists, medical writers, statisticians, data management, members of multidisciplinary project teams and their managers to review and interpret data
- Contribute to the preparation of abstracts, presentations and manuscripts
- Work with clinical team and other resources to select trial investigators and clinical sites
- Ensure that appropriate resources are utilized to provide expert and timely support of clinical trials, including the selection and management of external entities (such as CRO's and other vendors)
- Attend clinical, scientific and investigator meetings representing the company as a medical expert regarding drug development candidates
- Oversees the portfolio management activities for the company to ensure appropriate objectives and resources are deployed to meet strategic portfolio plans delivering on key milestones to advance all of the company's products in development
- Is responsible for representing the company with regulatory and legislative agencies, addressing the scientific and medical/health aspects of the company's product portfolio
- Provides guidance on health-related matters to leaders across the company and with outside health/medical and regulatory organizations
- Works closely with corporate Business Development to search and evaluate new opportunities within the biotech/pharma industry
The Successful Applicant
- Advanced Medical degree with focus on Oncology preferred
- Background in solid tumours will be an advantage
- 8-10+ years clinical development programs from First-in-Human to later stages
- Good knowledge of CDE and FDA requirements toward Cell therapy submission will be an advantage
- Up to 5 years experience working in a team environment with 3 years in a supervisory position managing direct reports
- 2-3 years of experience managing budgets and supervisory experience desired
- Excellent written, presentation and verbal communication skills
- Entrepreneurial mindset and passion to drive 'innovation in China for Global'
What's on Offer
You will be hired as a Strategic and Operational leаder of Clinical Development and Medical function shaping day-to-day activities as long as long-term function strategy and vision.
You will be offered Partner status with founding team and enjoy competitive salary package and bonus scheme along with the opportunity to advance TIL therapy for global patients.