Associate Director/Sr. Manager Clinical Trial Management

About the Company

Protego focuses on the discovery and development of first-in-class small molecule therapeutics that aim to reprogram protein folding for the treatment of various diseases. We are exploring monogenic protein misfolding diseases that cause myopathy, cardiomyopathy, stroke, renal disease, retinal diseases, channelopathies, and various degenerative diseases. Our approach builds on the proven pharmacological chaperones approach previously exemplified by tafamidis, which was discovered and developed by our cofounders Dr. Jeffery W. Kelly and Dr. Richard Labaudinière, for the treatment of transthyretin amyloidosis.

About the job

The incumbent will be responsible for independently managing operational aspects of assigned clinical trials. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role requires a deep understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams to ensure high-quality, timely, and cost-effective trial execution. The ideal candidate will bring an in-depth understanding of managing clinical trials at a sponsor biotech.

Essential Functions And Responsibilities

• Lead the planning, initiation, execution, and close-out of complex Phase 3 trials. Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.
• Manage the day to day operations of clinical studies, including oversight of CROs, central labs, biometrics, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards.
• Manage, mentor, and support direct reports, fostering professional development and team performance.
• Participate in site selection, feasibility assessments, and initiation visits..
• Oversee the development and review of essential study documents such as protocols, informed consent forms, monitoring report, case report forms (CRFs), monitoring plans, and study manuals.
• Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO study monitors; review a subset of monitoring reports to ensure consistency and quality, and to provide sponsor oversight.
• Oversee ongoing data reviews and support data cleaning activities.
• Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF).
• Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders.
• Work closely with internal stakeholders including Clinical Development, Regulatory Affairs, Quality, and CMC to ensure alignment and smooth execution of clinical programs.
• Provide guidance and mentorship to junior team members and cross-functional colleagues. Share best practices and contribute to continuous process improvement.
• Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings.
• Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance.
• Willingness to travel up to 10% for site visits, investigator meetings, , and conferences.

Required Education, Experience, Skills, And Abilities

• Bachelor’s Degree in related scientific field with a minimum of 10 years of experience in clinical research, with at least 5 years in clinical trial management.
• Proven track record of leading trials 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 and clinical trial systems (e.g., CTMS, eTMF, EDC).
• Ability to interpret and analyze clinical data and metrics.
• Excellent communication, leadership, and interpersonal skills.
• Strong organizational and time management abilities.
• High level of accountability, adaptability, and attention to detail.
• Ability to work independently and collaboratively in a fast-paced, matrixed environment.

Salary Range: $155,000 - $215,000 a year

In addition to a competitive base salary ranging from $155,000 to $215,000 dependent on level and experience, 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.