Catalyst Biosciences is seeking an accomplished individual to serve as the Senior Manager, Clinical Operations reporting to our Head of Clinical Operations. The incumbent will manage the overall operation of our clinical studies including project planning, budget, resource management and CRO management.
About Catalyst Biosciences, the Protease Medicines company
Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a pre-clinical C3-degrader program partnered with Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and C4b-degraders designed to target disorders of the classical complement pathway as well as other complement programs in development.
- Manage daily operations of studies to ensure compliance with applicable GCP/ICH guidelines and other regulatory requirements
- Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical, manufacturing, regulatory affairs) in order to accurately coordinate clinical study activities
- Coordinate clinical study timelines with project leaders to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
- Conduct study monitoring visits and co-monitoring visits as needed
- Provide regular updates of study progression to stakeholders
- Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
- Management of quality at the investigative sites, vendors and data; maintain clinical study files per ICH guidance
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
- Assist with data reports, presentations and study documents
- Training for investigators and sites
- Recommends and implements innovative process ideas to impact clinical trials management
**Title/Level to commensurate with education and professional experience.
- BA/BS degree with 5 plus years clinical trial management experience or advanced degree (MS/PhD/PharmD) with at least 3 years clinical trial management experience
- Understanding of ICH/GCP guidelines and protocol and clinical drug development processes, clinical study design, study planning and management and monitoring
- Experience managing CROs and other vendors
- Demonstrated project management skills and study leadership ability
- Proven leadership skills, executive presence, maturity, emotional intelligence, attention to detail, excellent written and verbal communication, problem solving with various working assumptions, intangible variables and incomplete information
Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to firstname.lastname@example.org, referencing requisition number (CD21-274) in the subject line.