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CytoDyn Inc.

Reports to: Senior Executive VP of Clinical Operations

Location: Remote

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.

Responsibilities

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.

Qualifications

  • 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.

Work Style

  • 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.

Benefits

  • 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.

Please send your cover letter and resumé to: careers@cytodyn.com

CytoDyn Inc.

Reports to: Chief Operating Officer

Location: Remote

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 clinical project manager will play a huge and very important role in clinical trial procedures and will entail a wide range of functions to assist in conducting various clinical studies. This role involves planning, organizing, and communicating timelines of clinical activities to cross-functional team members involved in conducting and supporting clinical projects to make sure that they are in line with general clinical goals and objectives. In this role you will oversee the management of all aspects of clinical trials, including resolving of operational aspects of trials in conjunction with project teams to ensure that the studies are conducted following clinical trial protocols. You will also oversee the selection of vendors, non-breaching of contract, preparing clinical budgets and resource planning. You will act as the primary contact for vendors and leads in planning and communication with diverse internal and external study teams to make sure that trials are conducted and executed effectively in accordance with standard operating procedures (SOPs), good clinical practice (GCP) and regulations. You may be required to take part in supporting the preparation regulatory submissions. You must maintain a good relationship with study sponsors, CROs, consultants, and medical research team.

Responsibilities

  • Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines
  • Assist in preparing and reviewing documents that are related to assigned clinical study
  • Arrange and coordinate clinical project meetings
  • Ensure the availability of necessary resources for the execution of clinical projects
  • Review and approve invoices being presented by study vendors and external consultants
  • Answerable to questions and issues brought up by vendors and external consultants
  • Lead the clinical project team and various study team meetings
  • Utilize project management tools to ensure timely execution of all activities related to clinical milestones, proactively identify critical path activities and allocate resources to mitigate bottlenecks
  • Fully involved in resolving issues; take part in procedure improvement initiatives
  • Attain clinical study’s goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the process
  • Coordinate work with clinical trial managers, medical writers, and document control personnel to manage clinical study documents
  • Regularly update senior management on progress in clinical programs

Qualifications

  • Must possess excellent communication and presentation skills to be able to effectively convey messages across to both study team members and other external persons like vendors and consultants
  • Good problem-solving, organizational, and leadership skills are highly required
  • Ability to work with little or no supervision
  • Ability to always pay keen attention to detail
  • Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects
  • Must be able to work as part of a team or in most cases lead a team
  • Must have a ‘one of a kind’ work ethic, and must exhibit a great level of self-discipline
  • Ability to organize and motivate other members of the study team
  • 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/inconsistencies in regulatory documents
  • Proven ability to work in a fast-paced, innovative environment and independently execute
  • Proven track record working with clinical project management
  • Able to travel as required

Requirements

  • A Bachelor’s and/or a master’s degree in a scientific discipline or health related field
  • A minimum of 10 years of biopharmaceutical experience in clinical programs
  • Proficient in MS Project
  • Proficient user of basic computer applications for the execution of daily project operations
  • Experience in clinical study protocols and other clinical documents is a plus

Benefits

  • Competitive salary, bonus, and stock option
  • 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

Please send your cover letter and resumé to: careers@cytodyn.com

CytoDyn Inc.

Reports to: Corporate Counsel

Location: Vancouver, WA (Corporate Headquarters Office)

Compensation: Commensurate with experience

Hours per week: Full Time 

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 also rapidly evaluating its drug, leronlimab, to treat COVID-19 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 human metastasis and in immune- mediated illnesses 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 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 Company is seeking a high-performing paralegal interested in gaining hands-on experience at a publicly traded company assisting with the administration of securities and other tasks. You will have the opportunity to play a key role assisting with the end-to-end administration (issuances, exercises, transfers, etc.) of warrants, RSUs, options, stock subscription agreements and other investor documents. Additionally, you will assist in the processing of restricted stock legend removal and Rule 144. This position will interact with outside legal counsel, investors, transfer agent, brokerage firms, and the finance team. You will also assist with the administering of securities and investor related documents for execution via DocuSign.

Work Style

  • Ability to effectively function, prioritize, and execute in a fast-paced, dynamic environment.
  • Flexible, fearless, and excited about your part in our growth.
  • You like to take on new challenges and take the initiative.
  • Proactive resourcefulness and initiative to ask questions coupled with the ability to self-manage.
  • You're willing to help wherever needed.
  • Attention to detail and strong organizational skills
  • Drive to do what it takes to ensure the job is done.
  • A learner with a mindset centered around continuous improvement.
  • Thrive operating in a rapid growth environment.
  • Expert at applying past relevant experiences to define, create and implement best practices.

Qualifications

  • Experience with publicly traded companies.
  • Good understanding of securities law, restricted stock, SEC registration statements, and Rule 144, or strong willingness to learn.
  • General understanding of SOX 404 and implications of following internal controls and processes.
  • Ability to establish priorities, meet deadlines, multi-task, work independently, and execute objectives with minimal supervision.
  • Excellent teamwork and collaboration skills.
  • Proficient in Microsoft Office.
  • Good sense of humor.

Benefits

  • 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: careers@cytodyn.com

CytoDyn Inc.

Reports to: Chief Operating Officer

Location: Remote

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 evaluate its effectiveness in multiple other autoimmune indications where CCR5 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 will provide leadership on global clinical regulatory activities for multiple therapeutic programs. The position is responsible for developing and implementing overall clinical regulatory strategy, risk assessment, regulatory interactions, and submissions, including BLA/MAA.

Responsibilities

  • Provide regulatory guidance and develop creative regulatory strategies for clinical development programs.
  • Develop comprehensive plan for timely execution of regulatory activities.
  • Work closely with internal team members and external consultants to manage preparation of high-quality documents for IND/CTA, BLA/MAA submissions in a timely manner.
  • In close collaboration with other functional areas prepare, review, or approve regulatory meeting requests and background information packages, and lead the preparation for meetings with the regulatory agencies.
  • Partner with Clinical Operations and Quality to ensure operations are compliant with regulatory and industry standards.
  • Establish, update, and implement regulatory policies, standards, and procedures.
  • Manage regulatory aspects of programs and collaborate with project management to ensure timely completion of deliverables.

Qualifications

  • Proven track record of successful IND/CTA, BLA/MAA submissions for therapeutic biological products.
  • Experience in global regulatory submissions and approvals.
  • Proven ability to author and review relevant documents for regulatory submissions and respond regulator queries.
  • Experience in preparing meeting requests, briefing documents, scheduling, organizing and leading meetings with regulatory authorities.
  • Comprehensive understanding of regulations of FDA, EMA, and other global clinical trial regulations, as well as extensive knowledge in the drug development process.
  • In-depth knowledge of ICH and FDA guidelines, and GxP regulations.
  • Excellent verbal, written and presentation skills.
  • Expertise in translating regulatory requirements into practical, workable plans.
  • 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/inconsistencies in regulatory documents.
  • Proven ability to work in a fast-paced, innovative environment and independently execute.
  • Proven track record working with regulatory agencies.
  • Able to travel as required.

Education

  • Bachelor’s or master’s degree in a scientific discipline with a minimum of 10 years of biopharmaceutical experience in Regulatory A Ph.D. is preferred.
  • Regulatory Affairs Certification is desirable.
  • Computer literacy is required.

Benefits

  • Competitive salary, bonus, and stock option
  • 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

Please send your cover letter and resumé to: careers@cytodyn.com