Clinical Trial Manager

Who We Are

Cogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis (SM), a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Top-line results from registration-directed trials in NonAdvanced SM, Advanced SM and GIST are expected in 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.

Our Team

https://cogent.culturehq.com

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, with the potential to support 3 pivotal clinical trials and other projects.

Cogent is a growing clinical-stage biopharma company seeking Clinical Operations Professionals who strive in a fast-paced environment.  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 and communicate with a variety of stakeholders.

Responsibilities include support of study execution, data cut activities, timelines, budget, and vendor management. You will also be responsible for the preparation of study-related materials, relationship management between clinical sites and vendors, and support identification of project risks and escalations. The ideal candidate must be comfortable working independently, managing interactions with and between team members, both internally and externally. You will ensure trial(s) are managed to the highest quality to ensure the safety and effectiveness of Cogent’s products.

• 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.
• Support data cut deliverables with urgency and quality
• Support Inspection Readiness activities
• Support study team meetings as a member of the Clinical Operations Team
• 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.
• Support the evaluation of study vendors, budgeting and accrual activities for clinical sites and vendors
• Opportunity to support 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 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 (~5%).

• 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

Our Locations

Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.

Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor.  Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization.

Our Offer To You

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.

We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.