Director / Sr. Director, Clinical Operations
CBT Pharmaceuticals, Inc. is an innovative biopharmaceutical company committed to becoming a global leader in the development of oncology combination therapies by focusing on therapeutics harnessing the immune system and targeting specific molecular pathways to tame cancer. CBT has two novel humanized monoclonal antibodies – CBT-501, targeting the Programmed Death-1 (PD-1) membrane receptor of immune cells, as well as Programmed Death Ligand-1 (PD-L1) (CBT-502) that restores the body’s immune system to recognize and kill cancer cells. In addition, CBT-101, is an oral c-MET inhibitor targeting the epithelial to mesenchymal transition (EMT) pathway and CBT-102, an oral multi-targeted kinase inhibitor that targets uncontrolled growth signaling pathways. The company was founded in 2016. For more information, please visit www.cbtpharma.com
Director / Sr. Director, Clinical Operations Description
Reporting to the Chief Operating Officer (COO), based in the San Francisco Bay Area, the Director/Sr. Director, Clinical Operations responsibilities will include oversight for clinical study conduct including leading internal and external (CRO) sub-teams, study planning, budgeting, and financial oversight, vendor/partner management, monitoring study and program timelines, and ensuring compliance with GCP. This position works in a cross-functional environment with representatives from other involved functions. He or she will contribute to, and support, corporate goals to progress the company’s portfolio of products.
Primary Duties and Responsibilities
- Anticipate project requirements and institute appropriate actions to ensure timelines and project goals are met.
- Oversight of designated activities outsourced to CROs, external consultants, central and specialist labs and other vendors.
- Participates in developing and drafting protocols, amendments, CRF, informed consent forms, Investigator Brochures, annual progress reports, clinical study reports and other documents as needed or requested.
- Review required clinical documents, if developed by vendors/partners.
- Responsible for the development of, and the oversight for, clinical study milestones to support program objectives.
- Develop study specific monitoring plans and ensure appropriate quality and timely monitoring of clinical sites.
- In conjunction with the CRO project manager, review trip reports and other aspects of site monitoring including, performance metrics and quality. Identify, troubleshoot and resolve issues pertaining to site monitoring for in-house and CRO monitored studies.
- Conduct pre-study, initiation, routine monitoring and closeout visits of study sites, when necessary.
- Oversee study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation for domestic and international clinical studies.
- Ensures that clinical studies are properly resourced, managed, and executed following the study plan and in accordance with established timelines and quality standards.
- Provides high level oversight of clinical study data, i.e., flow from the sites (CRF completion) to data entry (data entered into database) to data listings/tables/figures.
- Ensures that clinical studies follow guidelines and necessary processes and procedures, as applicable (e.g., Code of Federal Regulations, ICH Guidelines and Good Clinical Practices, FDA, EMA, PMDA) and appropriate industry standards.
- Develops work processes or fosters an environment that enhances the cross-functional effectiveness of clinical operations with other functions such as biostatistics, data management, CMC, medical writing, regulatory, finance, and legal, whether these functions are internal or external to CBT Pharmaceuticals.
- Develops and/or utilizes appropriate metrics to assess performance, compliance, and cost effectiveness.
- Ensures audit readiness at all times.
- Selects and oversees, effectively manages, and collaborates with CROs/vendors/partners and build strong relationships at the senior levels within those organizations.
- Ensures adherence to vendor/partner scopes of work, including timelines and budgets, while providing insight and guidance around potential study changes to ensure efficiency and mitigate against fluctuating study costs or study delays.
- May be responsible for direct supervision or line management.
- Creates a positive and productive work environment for attracting and retaining highly qualified clinical professionals.
- Perform other duties as assigned by management.
- Masters Degree or Doctorate in Biological Science or equivalent in allied healthcare.
- Pharmaceutical, biotechnology, or clinical research experience for a minimum of 12 years, among which, more than 8 years are in Pharmaceutical and Biotechnology industry including demonstrated skills and competency in monitoring and clinical project management tasks.
- Thorough knowledge of ICH Guidelines, GCP and the clinical trial process.
- Understanding of data management, statistical programming and regulatory affairs sufficient to perform project management responsibilities.
- International clinical trial management experience is a plus.
- Insight of study budget process including vendor and Investigator agreements and contracts, CRO budgets, invoicing and payments, site budgets and payment administration.
- Builds connections by developing positive, collaborative partnerships that drive sustainable business results.
- Experience with clinical protocol design, clinical trial operations, clinical trial bio-specimen logistics, analytical and clinical validation of biomarker assays, and vendor interactions.
- Demonstrated ability to think strategically and creatively while contributing to multiple projects.
- Thrives in a highly collaborative, multi-disciplinary team setting.
- Highly effective verbal and written communication skills.
- Solid working knowledge of a range of computer packages including Microsoft Office software
- Ability to manage clinical projects with minimum supervision.
- Ability to train / supervise and mentor junior staff.