Senior Clinical Trial Manager

About the Company

Protego Bio is a clinical-stage biotechnology company based in San Diego, California, focused on developing first-in-class small-molecule therapeutics that target protein misfolding diseases. By restoring protein stability and function through novel pharmacological chaperones, Protego aims to transform the treatment of rare and systemic diseases with significant unmet medical need.

Protego's lead program is being developed for AL amyloidosis and builds upon the clinically validated pharmacological chaperone approach pioneered by our cofounders, Dr. Jeffery W. Kelly and Dr. Richard Labaudinière, whose work led to the discovery and development of tafamidis for transthyretin amyloidosis (ATTR).

About the job

The Senior Clinical Trial Manager (Sr. CTM) will be responsible for independently managing the day-to-day operational execution of assigned clinical trial activities, to ensure they are completed on time, within budget, and in accordance with the protocol, SOPs, and applicable ICH/GCP and regulatory requirements. The Sr. CTM partners closely with cross-functional study teams and CRO/vendor partners to drive trial execution across all phases of clinical development, and serves as a key operational contributor within the Clinical Operations function, reporting to the Senior Director, Clinical Operations.

Essential Responsibilities

Study Operations & Leadership

• Independently manage the day-to-day operations of assigned clinical trial activities, ensuring milestones are met on time, within budget, and to quality standards.
• Lead the internal cross-functional study team for assigned study activities (Phase 3) or studies (Phase 1) to identify operational risks and issues and propose mitigation strategies.
• Serve as the primary operational point of contact for assigned clinical trial activities, ensuring alignment between the sponsor and CRO(s) teams.

Vendor & CRO Management

• Manage CROs and other specialty clinical vendors (e.G., central labs, bioanalytical labs, TMF, IRT, imaging, etc.) to ensure timely, high-quality deliverables.
• Review vendor work orders, change orders, and study invoices, and participate in accrual reviews to track the financial status of the study against budget.
• Provide guidance to CRO study monitors and review a subset of monitoring/visit reports to ensure consistency and quality and to support sponsor oversight.

Site Management & Quality Oversight

• Ensure inspection readiness at all times, including regular review and oversight of the Trial Master File (TMF).
• Ensure timely identification and resolution of site- and monitoring-related issues, escalating risks to study leadership as appropriate.
• Ensure set-up and implementation of effective investigator and site staff training;
  coordinate operational and therapeutic-area training for internal and external study team members.

Data & Documentation Oversight

• Participate in the clinical aspects of timely data cleaning, data review, and reconciliation to support database lock and the availability of clean data for analysis.
• Participate in the development and review of essential study documents, including protocols, informed consent forms, monitoring plans, case report forms (CRFs), and study manuals.
• Participate in review of study documents (including pharmacy, laboratory, and operations manuals).
• Ensure all study documentation is maintained in accordance with GCP and company SOPs.

Cross-Functional Collaboration

• Work closely with internal stakeholders including Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Quality, and CMC to ensure alignment and smooth execution of clinical programs.
• Prepare and deliver study updates, metrics, and presentations to the project team and senior leadership;
  represent Clinical Operations in internal and external meetings.
• Provide guidance and mentorship to junior team members (e.G., Clinical Trial Associates/Coordinators) and cross-functional colleagues, sharing best practices.
• Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance.

Required Education, Experience, Skills, And Abilities

• Bachelor's Degree in a related scientific field required;
  advanced degree a plus.
• Minimum of 7-10 years of experience in clinical research/clinical operations, including direct experience managing CROs in support of clinical programs.
• Experience managing early-stage Phase 1 studies is a plus.
• Knowledge of Mandarin is a plus.
• Proven track record independently managing components of clinical trial from start-up through close-out, including protocol development, site initiation, vendor management, and data review.
• Strong knowledge of ICH GCP, FDA regulations, and global clinical research guidelines.
• Proficiency in MS Office Suite and clinical trial systems (e.G., CTMS, eTMF, EDC).
• Ability to interpret study metrics.
• Excellent organizational skills and attention to detail;
  able to set priorities and manage multiple competing demands.
• Able to think critically to prospectively identify operational risks and issues and propose solutions.
• Able to work independently while exercising initiative, flexibility, and sound judgment.
• Excellent verbal/written and interpersonal skills;
  comfortable working with all levels of the organization, including senior management.
• Ability to work in and effectively contribute to cross-functional teams in face-to-face conversation, by telephone, and by email.
• Occasional travel may be required, up to approximately 10%, for site visits, investigator meetings, and conferences.

Salary Range: $160,000 - $190,000 a year

In addition to a competitive base salary, we offer stock options and a target bonus. Protego also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.

Please note that the salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.

Job Type: Full-time

Benefits

• Annual bonus program
• Incentive stock option plan
• 401k plan with employer contribution
• Comprehensive medical insurance
• Dental and vision insurance
• HSA, FSA, and supplemental insurance plans
• Paid Time Off
• Company paid holidays

Schedule

• Monday to Friday

Work Authorization

• United States (Required)

Additional Compensation

• Annual targeted bonus %

Work Location:

• Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 10% for meetings or site visits as required.

Equal Opportunity Employer

Protego Biopharma, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.