Director/Senior Director, Clinical Operations

Job Description

Job Description

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 provide global operational leadership overseeing complex clinical programs. This role is responsible for efficient planning, resourcing and execution of portfolio level programs in adherence to ICH-GCP, FDA regulations, and company SOPs. The Senior Director will report into the Head of Clinical Operations and will ensure strategic alignment of programs and key stakeholder management in a fast-paced environment, while mentoring and growing the Clinical Operations team and culture to ensure successful program delivery.

Primary Responsibilities

• Accountable for global clinical operations strategy and execution for programs including providing strategic direction to study teams to ensure timely clinical trial execution. .
• Collaborate effectively cross-functionally with senior leadership to ensure operational initiatives support strategic company goals.
• Accountable for maintaining inspection-readiness across clinical programs.
• Assist in development of hiring/resourcing plans and program budgets.
• Establish and refine scalable best practices to drive efficiency while preparing for future departmental growth.
• Accountable for development, of study documents, including informed consent forms, CRFs, monitoring plans, and pharmacy manuals ensuring consistency among programs.
• Responsible for successful external partner relationships including clinical CROs, any other vendors supporting the clinical studies to ensure timely and quality deliverables.
• Ensure deliverables are met on time, within budget, and to quality standards.
• Responsible for Preparation and delivery of program updates to internal teams.
• Responsible to establishment of study-level KPI and QTLs.
• Mentor and support direct reports, including consultants.

• Oversee site strategy and establish Clinical Operations team relationships with investigators and key opinion leaders.
• Accountable for establishing clinical operations SOPs.to ensure compliance and inspection readiness.
• Responsible for development of and implementation of operational plans, timelines, and budgets for clinical programs.

• All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.

Required Education, Experience, Skills, And Abilities

• Bachelor’s degree in life sciences or related field with 12+ years of experience in clinical research, including at least 10 years in clinical trial management. Advanced degree preferred.

• At least 5 years’ experience managing direct report, evidencing strong leadership, team-building, and hands on management.

• Track record of leading complex clinical programs from start to completion
• Strong experience in conduct of late stage clinical trials in rare disease indications.
• Experience in preparing programs for FDA inspections and hosting FDA inspections is a strong plus.
• Ability to define strategy and ensure organizational goals are executed in global clinical operations plans.

• Ability to set priorities and juggle multiple demands..
• Ability to think critically and be a proactive problem-solver.

• Ability to work independently and collaboratively in a fast-paced, matrixed environment.
• Comfortable working with different levels of the company including senior level management.
• Strong knowledge of ICH GCP, FDA regulations, and global clinical regulatory guidelines.
• Strong IT skills in MS Office and clinical trial systems (e.g., CTMS, eTMF, EDC).
• Expertise in clinical budgeting and efficient allocation of resources in resource-constrained circumstances.
• Demonstrated success in leading, mentoring, developing diverse clinical teams and providing oversight to CROs.

$235,000 - $260,000 a year

In addition to a competitive base salary ranging from $235,000 to $260,000, 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 (life, disability, accident, critical illness)
• 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 25% for meetings or site visits as required.

Equal Opportunity Employer Protego Biopharma 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.