Reports to: Clinical Development Lead
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 position is accountable for the successful global and regional execution of regulatory submissions both CMC and Clinical Development and any other duties as defined by CytoDyn.
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 CMC and 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
- 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 GMPs as well as GCPs-experience in adhering to them or bringing them up to speed.
- 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.
- 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.
- Bachelors or Master’s Degree will be considered with relevant experience of 10 or more years in Regulatory
- 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.
- 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: email@example.com