Senior Clinical Trial Manager

Who We Are

Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.

The Role:

The successful candidate will be responsible for supporting all aspects of clinical trial management for a novel precision kinase inhibitor in rare disease. This role will provide a lot of opportunities to make substantial contributions to this complex and novel treatment paradigm.

Cogent is a growing clinical-stage biopharma company seeking Clinical Operations Professionals who strive in a fast-paced environment.  The CTM role will support an ongoing global Ph2 study for patients suffering from Advanced Systemic Mastocytosis.  We are looking for someone who can bring significant capability to deliver on the operational needs of the role, while bringing a thoughtful perspective, drive for results, collaborative approach, and the ability to work with, influence, and communicate with a variety of stakeholders.

Responsibilities

• Support the implementation of clinical research studies within budget and on schedule.
• Manage activities of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives.
• Coordinate and lead study team meetings and update the Clinical Team on timelines and milestones for the study.
• Train team members and site staff, including vendors, as needed
• Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs.
• Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
• Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendors
• Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, motivational, and sponsor oversight visits, as needed
• Provide sponsor oversight of vendors and CROs, specifically leading oversight activities related to clinical monitoring from site qualification to site closure visits and assure integrity of clinical data with respect to accuracy, accountability, and documentation through review of case report forms, source documents, and medical records. Evaluate and analyze site trends, evaluate study risks and mitigation strategies, and work with the cross-functional team in the review of clinical data.
• Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house.
• Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs.
• Limited travel possible to field sites to supervise and/or monitor clinical studies (~25%).

Qualifications

• BS/BA Degree or equivalent in science or a health-related field is preferred.
• Minimum 4-6 years of relevant industry clinical development experience.
• Experience with complex therapeutic platforms.
• Rare diseases/oncology clinical trials.
• Experience with all aspects of trial and site startup and vendor selection and management, study management, and monitoring.
• Familiarity with clinical data review and data management processes.
• Excellent knowledge of GCP, ICH, and FDA regulations.
• Experience with SOP review and development.