Position: Clinical Trial Manager – Clinical Operations

Reports to: Vice President - Clinical Operations

Location: Remote

About CytoDyn Inc.

CytoDyn Inc. (the “Company”) is a publicly traded 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 inflammation. 

Summary of Position

The position is accountable for the successful execution of in-house and outsourced clinical trials assigned by their manager, across multiple therapeutic areas. Responsibilities include ensuring that all activities are conducted within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. This position will interface with other applicable teams both internal and external and, as needed, visit clinical trial sites and interface directly with site personnel.

Responsibilities

The position is considered a critical study team member, with a focus on trial management supervision and trial monitoring of in house and outsourced clinical trials. The position takes part in the End-to-End Process, which includes trial set-up, execution, data analysis, and reporting (includes trial closure) and post-study activities. The position also measures and reports study progress against agreed upon timelines to milestones.

• Coordinates and tracks trial deliverables and timelines.
• Develops and tracks key trial KPIs such as enrollment, site activation, trial completion and other key milestones.
• Ensures timely and accurate documentation and communication of study progress and issue escalation.
• Ensures that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA and other relevant regulations and guidelines.
• Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits.
• Provides 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.
• Ensures accurate budget management for assigned trials. This includes ensuring vendors and affiliate budgets are tracking according to plan and updates are made to account for scope changes.
• Ensures that study monitoring is performed as per sponsor or 3rd party SOPs, tracks monitoring progress through reliable metrics and escalates any concerns appropriately.
• Helps with developing in house SOPs relevant to clinical science and operations.
• Oversees Clinical Research Organization (CRO).
• Manages other functional service providers (non-CRO) relationships to ensure work is being performed in accordance with contract specifications.
• Works with staff in Clinical Operations to provide enrolment and feasibility data as needed.
• Any other duties as assigned by the Functional Manager.

Work Style

• Flexibility and ability to function in a dynamic work environment.
• Welcomes new challenges and takes initiative.
• Takes ownership and pride in their 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.
• Effective leadership skills and proven ability to foster team productivity and cohesiveness.
• Capable of multi-tasking and working well under pressure to meet deadlines coupled with a good understanding of working in a team environment.

Qualifications

• BS degree or equivalent in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 5 years clinical trial experience (Clinical Research Associate, Clinical Trial Specialist, Trial Field Monitor, Clinical Trial Manager) in the pharmaceutical industry, with a working knowledge of the ICH and FDA guidelines.
• Experience working with clinical Contract Research Organizations
• Requires clinical research operational knowledge, including study design, execution and data management.
• Project planning/management and communication skills.
• Computer literacy, including experience in CTMS, EDCs and the MS Office Suite of programs with a strong working knowledge of Excel.
• Experience with and understanding of clinical trial budgets, resources, process and controls, quality and project delivery.
• 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. 

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 employees to set aside pre-tax wages for medical costs.

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

Position: Project Manager – Chemistry, Manufacturing and Control

Reports to: VP - Operations

Location: Remote

About CytoDyn Inc.

CytoDyn Inc. (the “Company”) is a publicly traded 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 inflammation. 

Summary of Position

The CMC Project Manager will support the VP – Operations by supporting the clinical supply chain, the Document Control function, regulatory submissions for documents such as annual reports. The successful candidate works well in a fast paced, dynamic environment and will “hawk the details”. 

Responsibilities

The Project Manager, CMC, will play a leading role in:

• Management of Systems and Processes to support packaging, labeling, storage and distribution of product:
  • For clinical studies (for example, aid in the establishment of IRT)
  • Work with third party providers to establish master batch records and review of executed batch records.
• Responsible for processing shipment requests for drug product, drug substance and other items:
  • Creating and logging requests into shipment tracking system, submitting to distributor.
  • Working with distributor to coordinate shipment of bulk material, including communication with Customs Brokers and international couriers.
  • Monitoring routine shipments (e.g. stability samples) and providing details to Customs Brokers as required.
  • Obtaining Acknowledgements of Receipt and other information as appropriate for shipments.
  • Working with QA and QC to resolve temperature excursions.
• Responsible for inventory control/maintenance including:
  • Inventory reconciliation.
  • Processing destruction requests
  • Notification of shelf life and expiration date extensions.
• Organizational support of Chemistry Manufacturing and Control Team:
  • Summarizing stability study data in data tables
  • Ensure documents are filed in appropriate locations (for example, executed batch records).
  • Routing documents for approval as required (for example, using DocuSign).
  • Other support activities as required.
• Support Document Control Function
  • Management of review of SOPs and other controlled Documents
  • Support Quality Logs for items such as CAPA, Change Control

Work Style

• You are highly organized.
• You can work within an environment with multiple priorities.
• You are self-sufficient and know when to ask questions.
• You're willing to help wherever needed.
• You take ownership and pride of your work.
• You are a learner with a mindset centered around continuous improvement.
• You strive to do what it takes to ensure the job is done right the first time.
• You have the ability to function effectively, prioritize, and execute in a fast-paced, dynamic environment.
• You have a “Quality” mind-set.

Qualifications

• S./B.A. in life science, business operations, supply chain management or related fields.
• At least 3 years’ experience in the pharmaceutical industry within clinical development
• Excellent communication skills, both verbal and written.
• Must be detail oriented and have solid problem solving and organizational skills.
• Position requires compliance with standard operating procedures and international industry regulations.
• Working knowledge of Microsoft Office applications, particularly Microsoft Excel, Word and PowerPoint.
• Must be customer-service oriented.
• Experience with ex-US studies is a plus.
• Experience working in an ERP system is a plus.
• Individual must be comfortable working in a remote environment.

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 employees to set aside pre-tax wages for medical costs.

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