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 Associate Director (AD), Clinical Operations will be responsible for independently managing the operational execution of assigned clinical trials, including oversight of contract research organizations (CROs), vendors, and clinical sites across U.S. and international regions, to ensure trials are completed on time, within budget, and in accordance with the protocol, SOPs, and applicable ICH/GCP and regulatory requirements. The AD partners closely with cross-functional teams and CRO/vendor partners to drive trial execution across all phases of clinical development, and serves as a senior operational leader within the Clinical Operations function, reporting to the Senior Director, Clinical Operations.
Essential Responsibilities
Study Operations & Leadership:
Lead the planning, initiation, execution, and close-out of complex clinical trials, ensuring all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.
Manage the day-to-day operations of assigned clinical studies, ensuring 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 site initiation visits.
Vendor & CRO Management:
Oversee CROs and other clinical vendors, including central labs, biometrics, safety vendors, and eTMF providers, to ensure timely, high-quality deliverables.
Provide guidance to CRO study monitors and review a subset of monitoring reports to ensure consistency and quality and to support sponsor oversight.
Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders.
Site Management & Quality Oversight:
Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF).Ensure timely resolution of monitoring-related issues identified in monitoring reports.
Data & Documentation Oversight:
Oversee the development and review of essential study documents, including protocols, informed consent forms, monitoring reports, case report forms (CRFs), monitoring plans, and study manuals. Oversee ongoing data reviews and support data cleaning activities.
Cross-Functional Collaboration:
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, sharing best practices and contributing 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.
Required Education, Experience, Skills, And Abilities:
Bachelor's Degree in a related scientific field required, with a minimum of 10 years of experience 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.
Knowledge of Mandarin is a plus.
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 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.
Occasional travel may be required, up to approximately 10%, for site visits, investigator meetings, and conferences.
Salary Range: $180,000 - $210,000 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 insuranceHSA, FSA, and supplemental insurance plans
- Paid Time OffCompany paid holidays
- ScheduleMonday to FridayWork 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.
