Reporting to the Chief Operating Officer, the Director, Clinical Development Science / Project Team Leader will work closely with project teams and clinical study teams to provide direction, planning, execution, and interpretation of clinical trials and related data collection activities. The candidate will have a clear understanding of the drug development process (especially early phase clinical trials and investigator initiated studies), protocol writing and study conduct, the principles of translational medicine, and how to work effectively within cross-functional teams ensuring their success. CBT seeks a well-trained scientist/clinician with strong leadership skills who is driven by science and the desire to develop oncology therapies for cancer patients in a start-up “bio-tech” environment.
- Lead protocol implementation (author, develop, and amend) including site identification and communication, attendance at investigator meetings, corresponding with sites including IRBs, and interactions with clinical study teams and project teams.
- In conjunction with cross functional team members such as clinical operations and translation science, co-lead IND and other regulatory submissions, protocol and Investigator Brochure development, amendments and all supporting documents, PK/PD and clinical data collection and analysis, investigator and site communications, study reports and publications.
- Lead in clinical discussions on cross-functional sub-team meetings.
- Work with clinical operations and data management in database review, query and clean-up activities in real-time and prior to database lock. Work with the cross functional team in preparation of abstracts, posters, oral presentations and manuscripts.
- Work with the Executive Team and Medical Director in preparation for, and organization of, development advisory boards.
- Support program development across functions and data compilation for efficacy and safety evaluation.
- Ensure project teams meet the needs of the company by balancing process and flexibility to keep drug development moving quickly and efficiently.
- Keep project team, senior management, and strategic partners informed on progress to goals, as well as communicating issues and risks, and proposing and implementing plans to resolve such issues and execute corrective actions.
- Contribute to team strategy and operational logistics, including developing, reviewing critical documents, vendor management, in order to ensure they are in line with project goals and objectives. Identify program related risks and work with team to develop mitigation path.
- Manage program wide communication of critical issues; provide formal information briefings on project status to team members, function heads, senior management, and alliance partners.
- PhD, PharmD, MD or other relevant advanced degree in a health science field.
- Minimum of 10 years in clinical research and/or drug development in medical oncology/hematology; immune-oncology development experience preferred.
- Extensive experience in project management in a drug development environment and has successfully advanced a drug product from research through clinical trials and commercialization.
- Strong organizational, management, teamwork, interpersonal skills and professionalism required.
- Excellent clinical and scientific judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
- Outstanding communication skills (verbal and written). Reading and writing Mandarin is a plus.
- Collaborate effectively with the study team, cross-functional team members, and external partners.
- Attention to detail and ability to organize and prioritize tasks in a timely and accurate manner.
- Ability to work and manage multiple projects collaboratively in a fast-paced dynamic environment.
- Understanding of the pharmaceutical culture and the special requirements of completing projects within a regulated environment.
- Proficient with Windows: MS Office – Word, PowerPoint, Excel, Project, and ability to learn new programs as needed.
CBT Pharmaceuticals offers medical, dental, and vision insurance to keep you and your family healthy. CBT also offers competitive PTO days, so you can take time off when you need to. Plus, CBT offers a 401K plan that includes a company match.
CBT Pharmaceuticals, Inc. is an innovative biopharmaceutical company committed to becoming a global leader in the discovery and development of oncology combination therapies that harness the immune system and target specific molecular pathways to tame cancer. The company’s existing pipeline of five development-stage assets include three novel humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and two targeted therapies against uncontrolled growth signaling pathways.
The company was founded in 2016 with locations in Pleasanton, California and Hangzhou, P.R. China. The company will relocate to Foster City, California by 1Q2019.