Reports to: Chief Operating Officer
About CytoDyn Inc.
CytoDyn Inc. (the “Company”) is a publicly traded late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on the Company’s lead drug candidate, leronlimab, a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5 (CCR5) and known as entry inhibitor to Human Immunodeficiency Virus (HIV). Leronlimab is in a class of therapeutic monoclonal antibodies designed to address unmet medical needs in the areas of HIV, cancer, and immunology. With respect to HIV, the CCR5 receptor plays a key role in the ability of HIV to enter and infect healthy T-cells. With respect to cancer and immunology, the CCR5 receptor also appears to be implicated in cancer metastasis such as triple-negative breast cancer, other metastatic solid tumor cancers, graft-vs-host disease (“GvHD”), and non-alcoholic steatohepatitis (“NASH”). More recently, the Company expanded its clinical focus with leronlimab to include evaluating its effectiveness in multiple other autoimmune indications where CCR5 antagonism has shown initial promise, as well as a therapy against COVID-19 disease and COVID-19 long hauler symptoms. The Company targets leronlimab treatment as a therapy for patients who experience respiratory complications as a result of contracting COVID-19. The Company believes leronlimab provides therapeutic benefit by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in patients experiencing this syndrome.
Summary of Position
The position is responsible for rapid and compliant clinical trial start up activities including site contracts, patient recruitment planning and ongoing financial management of clinical trials for drug development and any other duties as defined by CytoDyn.
All clinical trials are fully outsourced, and responsibilities as described below will be conducted within the oversight of external service providers as applicable.
- Coordinates the delivery of the Site Services component of assigned studies within a country or region, (Including overall accountability for delivery to time, cost, and quality)
- Oversees CRO interactions with investigative sites during site start-up activities.
- Works with staff in Clinical Operations to provide enrolment and feasibility data as needed.
- Trial planning activities including patient recruitment strategies.
- Develops and negotiates site contracts.
- Tracks and approves trial invoices, reporting key information to senior management.
- Develops and tracks key trial start up KPIs such as enrolment, site activation, and other key milestones.
- Ensures all start up information & requirements, including SOPs, are kept up to date in a central repository for project teams.
- When needed, provides logistical support of clinical trial supply coordination.
- Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation.
- Any other duties as assigned by the Functional Manager.
- Flexibility and ability to function in a dynamic work environment.
- Welcomes new challenges and takes initiative.
- Proactive resourcefulness and initiative to ask questions coupled with the ability to self-manage.
- Takes ownership and pride of your work product.
- Drive to do what it takes to ensure the job is done.
- A learner with a mindset centered around continuous improvement.
- Ability to effectively function, prioritize, and execute in a fast-paced, dynamic environment.
- Expert at applying past relevant experiences to define, create and implement best practices.
- University/College degree (Life Science preferred) or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)
- Minimum 5 years work experience in the clinical research field with a working knowledge of the ICH and FDA guidelines.
- Clinical Development experience working as a Clinical Research Associate, Clinical Trial Specialist, Trial Field Monitor, or other equivalent experience.
- Experience working with clinical Contract Research Organizations
- Previous experience with investigator start-up documents and investigative sites is preferred.
- The ability to analyze and review data (to build evidence-based trial strategies)
- Capable of multi-tasking and working well under pressure to meet deadline coupled with a good understanding of working in a team environment.
- Computer literacy in Microsoft Office Suite
- Experience with and understanding of clinical trial budgets.
- Excellent communication (written and verbal) and collaboration skills.
- Ability to build effective relationships within a team/collaborative environment, with a high level of professionalism.
- Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
- Hands-on experience in working with CROs and an understanding of how to organize that relationship to ensure productivity.
- Competitive salary, stock option compensation, PTO, and Company holidays.
- 100% company paid medical/dental benefits for employees and all dependents.
- 401(K) Plan eligibility including employer “safe harbor” contribution equal to 3% of salary regardless of employee contribution.
- Flexible Spending Account (“FSA”) allowing employee to set aside pre-tax wages for medical costs.
Please send your cover letter and resumé to: firstname.lastname@example.org