Reports to: Senior Executive VP of Clinical Operations
About CytoDyn Inc.
CytoDyn is a publicly traded late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. The Company is rapidly evaluating its drug, leronlimab, to treat HIV, COVID-19, NASH and various forms of cancer.
Leronlimab is in a class of therapeutic monoclonal antibodies designed to address unmet medical needs in the areas of Human Immunodeficiency Virus (“HIV”), Cancer, and Immunology. With respect to HIV, the CCR5 receptor appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The Company’s lead product candidate, leronlimab, belongs to a class of drugs known as entry inhibitors. These therapies block HIV from entering into and infecting certain cells. With respect to Cancer and Immunology, the CCR5 receptor also appears to be implicated in cancer metastasis and in immune-mediated illnesses such as triple-negative breast cancer, other metastatic solid tumors, graft-vs-host disease (“GvHD”), and Non-Alcoholic Steatohepatitis (“NASH”). More recently, the Company is expanding the clinical focus with leronlimab to include evaluating its effectiveness in multiple other autoimmune indications where CCR antagonism has shown initial promise, as well as COVID-19. The Company targets leronlimab treatment as a therapy for patients who experience respiratory complications as a result of contracting COVID-19. The Company believes that 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 accountable for the successful global or regional execution of outsourced clinical trials assigned by their manager, across multiple therapeutic areas. Ensuring that all activities will be conducted within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. This position will interface with all other applicable teams both internal and external.
Considered the study owner with a focus on trial management supervision of primarily outsourced clinical trials. As part of the End-to-End Process includes trial set-up, execution, analysis and reporting (includes trial closure) and post-study activities. Measures study progress against agreed upon timelines to milestones.
- Ensure accurate budget management for assigned trials. This includes ensuring vendors and affiliate budgets are tracking according to plan. Updates are made to account for scope changes.
- Ensure enrollment commitments meet the projected enrollment across the regions at the clinical trial level, monitors patient recruitment at the global level, and ensure timely and accurate documentation and communication of study progress and issue escalation.
- Ensures that study monitoring is performed as per sponsor or 3rd party SOPs, tracks monitoring progress through reliable metrics and escalates any concerns appropriately.
- Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that clinical trials operate in a constant state of inspection-readiness.
- Data Management Oversight; accountable for delivery of data for planned deliverables i.e., Data Monitoring Committee (DMC) review, Interim Analysis (IA), Database Locks (DBL), etc.
- Ensure appropriate trial-specific training and in the set-up and coordination of Investigator Meetings, if applicable.
- Ensure deliverables are carried out according to the trial plan. Provides updates to all appropriate people or teams on the deliverable status. Ensure required reports are generated and available for real time tracking of trial status according to trial plan.
- Strong interaction with other functional teams as it relates to assigned projects.
- Any other duties as assigned by the Functional Manager.
- BS degree or equivalent in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum of 10 years clinical trial experience in the pharmaceutical industry, or equivalent.
- Requires clinical research operational knowledge, including study design and data management.
- Project planning/management and communication skills.
- Should be flexible and able to manage global or regional teams in a virtual environment.
- Excellent decision-making and strong financial management skills are essential to this position.
- Effective leadership skills and proven ability to foster team productivity and cohesiveness.
- Computer literacy, including experience in CTMS, EDCs and the MS Office Suite of programs with a strong working knowledge of Excel.
- Ability to work autonomously and independently in a very dynamic environment.
- Proactive resourcefulness and initiative to ask questions coupled with the ability to self-manage.
- Able to make decisions and lead with minimal supervision.
- You're willing to help wherever needed.
- Take 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.
- Competitive salary, bonus, and stock options.
- PTO and Company holidays.
- 100% company paid medical/vision and dental benefits for employees and 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.
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