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CytoDyn Inc.

Reports to: Clinical Development Lead

Location: Remote

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 accountable for the successful global and regional execution of regulatory submissions for Clinical Development and any other duties as defined by CytoDyn.

Responsibilities

All projects are fully outsourced and responsibilities as described below will be conducted within the oversight of external service providers as applicable.  

  • Experience with designing and executing creative development strategies for Regulatory Clinical Development programs.
  • Experience with submissions of successful BLA and/or NDA.
  • Experience with FDA and other Health Authority audits and inspections.
  • Comprehensive understanding of FDA regulations and ICH guidances, as well as comprehensive experience in the drug development process. 
  • Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in electronic Common Technical Document format.
  • Experience with international clinical trials and regulatory documentation.
  • Experience in preparation of critical submission documentation, and communications with FDA and other regulatory agencies. 
  • Experience in the regulations and regulatory controls of the MHRA, EMA and global Regulatory agencies.
  • Excellent communication (written and verbal) and collaboration 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 and/or inconsistencies in a variety of documents. 
  • Proven track record working with regulatory agencies.
  • Able to travel as required within a global work environment.
  • An understanding of ICH/GCP: experience in adhering to regulatory guidelines and managing others in compliance.
  • Hands-on experience in working with CROs and an understanding of how to organize that relationship to ensure productivity.
  • Any other duties as assigned by the Functional Manager.

Work Style

  • 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.
  • 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.

Qualifications

  • Bachelors or Master’s Degree will be considered with relevant experience of 10 or more years in Regulatory Affairs.
  • D. or Pharm. D. or a scientific discipline or equivalent is preferred with minimum of 7 years experience.
  • Regulatory Affairs Certification is favorable.  
  • Requires clinical research operational knowledge, project planning/management and communication skills.
  • Should be flexible and able to manage global or regional teams in a virtual environment.
  • Excellent decision-making skills are essential to this position.
  • Effective leadership skills and proven ability to foster team productivity and cohesiveness.
  • Computer literacy is also required.

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: CTO

Location: Remote

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

Director, Regulatory Affairs will translate regulatory requirements working effectively with the respective CMC and Clinical teams to collaborate, implement and interact meaningfully into workable strategies and plans for various stages of drug development. This individual develops and implements CMC regulatory strategies with the CMC team and collaborates with the clinical team to support regulatory submissions including INDs, CTAs, BLAs in the US and global markets for the development and commercialization of biologics and communicates with Competent Authorities while actively contributing as a key member of the product development team.

Responsibilities

The Director of Regulatory Affairs will play a leading role in translating regulatory requirements into practical, workable strategies and plans for development and commercial stage drugs.

  • Supports the Change Control process and implementation of Regulatory SOPs that relate to the Chemistry, Manufacturing and Quality Control of the product.
  • Develops regulatory strategies in collaboration with the cross-functional team.
  • Advises on the development and implementation of CMC regulatory strategies with manufacturing and other processes in mind; identifies potential risks and responds to new government/regulatory requirements.
  • Maintains current knowledge of regulations and guidelines (FDA, EMA, ICH, PMDA and others, as required) to support the development and authorship of communications such as regulatory meeting packages, communications with regulatory agencies worldwide, preparation of INDs, CTAs, BLAs, annual reports and supplements.
  • Supports Good Manufacturing Practice (GMP) for biologics and combination products and regulatory approval processes.
  • Reviews and writes CMC and other regulatory documents with respect to alignment with program strategy and consistency of scientific interpretations/messages, clarity, completeness, and regulatory requirements.
  • Proactively identifies program issues and implements appropriate regulatory strategies to mitigate risks.

Work Style

  • 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.
  • 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.

Qualifications

  • Minimum BA in Biological Science with more than 10 years’ experience in the Biopharmaceutical Industry. Higher degree is a plus.
  • Deep understanding and knowledge in biologics drug substance and drug product manufacturing and quality assurance (QA)/ quality control (QC) and GMP/GLP.
  • Knowledge and experience with Common Technical Document (CTD) structure, electronic (eCTD) submission requirements, and electronic document management systems.
  • Knowledge of Guidance documents related to CMC for International Conference for Harmonization (ICH).
  • Knowledge of US and EU Biologics, and Device Development (21 CFR Parts 3, 4, and 800) and Approval process.
  • Knowledge of Regulations, guidance, and procedures applicable to FDA, EMA, MHRA and other international regulatory agencies.
  • Excellent communication skills.

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: General Counsel

Location: Vancouver, WA (Corporate Headquarters Office)

Compensation: Commensurate with experience

Hours per week: Full Time 

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 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

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

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