Senior Clinical Trial Manager
- 200 Cambridgepark Dr, Cambridge, MA 02140, USA
Precision therapeutics for genetically defined diseases. Real solutions for real challenges.
Who We Are
Cogent Biosciences is a 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, PLX9486 (expected to be named CGT9486 in the future), 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 which can severely impact many different tissues and organs in the body. We are also studying PLX9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling.
What You Will Do
Reporting to and working collaboratively with the Sr. Director, Clinical Operations, the successful candidate will be responsible for all aspects of clinical trial management for a novel precision kinase inhibitor in rare disease and cancer indications. This role will provide a lot of opportunity to make substantial contributions to this complex and novel treatment paradigm.
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 include study planning and execution, 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 identification of project risks and contingency planning. 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 safety and effectiveness of Unum’s products.
- Plan and implement 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.
- Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, and designing CRFs.
- Lead/manage vendor selection and study start-up activities
- Review and negotiate contracts and budgets with CROs, clinical sites and vendors
- Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, and motivational visits, as needed
- Oversee 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 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.
- Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
- Develop SOPs, work instructions, and standardized forms to define Clinical Operations processes within a small but growing team.
- Train team members and site staff, including vendors, as needed
- Limited travel possible to field sites to supervise and/or monitor clinical studies (~25%).
- Opportunity to manage junior staff
For consideration at Senior Designation
Develop SOPs, work instructions, and standardized forms to define Clinical Operations processes within a small but growing team.
Take the lead in vendor selection and start-up
What You Bring
BS/BA Degree or equivalent in science or a health related field is preferred
Minimum 4-8 years of relevant industry clinical development experience (1-2yr in CTM project management for CTM role, 2-3+ in project management for Sr. CTM role)
Experiences with complex therapeutic platforms, rare diseases, and/or oncology
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
Cogent is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.
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), unlimited time-off, a 401(k) plan, and commuter/parking benefits.
- Cogent is an equal opportunity employer
- Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals