Preclinical/Nonclinical Development Leader (Director)

Reporting to: Chief Scientific Officer

This an exciting opportunity for a well-qualified candidate to join Optieum Biotechnologies, Inc., an early-stage company focused on transforming the lives of patients with their proprietary Eumbody System, a platform technology that enables the development of advanced CAR constructs that optimize immune-cell function for oncology and challenging diseases.

Reporting to the Chief Scientific Officer, this individual will:

1. Oversee the design, planning, and execution of preclinical/nonclinical studies to support IND-enabling activities for Optieum’s CAR T cell product candidates, including OPTF01.
2. Coordinate internal research efforts with external partners (CROs, consultants, and academic collaborators) to ensure high-quality, timely, and compliant data generation.
3. Ensure all preclinical requirements align with regulatory standards and the overall IND strategy.

Responsibilities

• Provide strategic and operational leadership for in vitro and in vivo preclinical studies evaluating the safety, efficacy, and pharmacology of CAR T and other immune-cell therapies.
  
  
• Develop, manage, and track detailed project timelines, budgets, and deliverables, ensuring alignment with corporate objectives.
  
  
• Oversee and direct work at Contract Research Organizations (CROs) and relevant consultants, including evaluating proposals, negotiating contracts, and monitoring project progress.
  
  
• Lead the design and review of experimental protocols, reports, and key regulatory documents to ensure preclinical milestones support IND submissions.
  
  
• Monitor and maintain the highest standards of data integrity and quality across all preclinical programs, addressing any deviations or out-of-specification (OOS) events in collaboration with Quality and Regulatory teams.
  
  
• Collaborate cross-functionally (e.g., Research, Process Development, Clinical, Regulatory) to facilitate a seamless transition from preclinical to clinical development.
  • Stay current on emerging scientific, technical, and regulatory trends in CAR T, cell, and gene therapies, integrating new insights into program strategies.
  • Represent Optieum Biotechnologies in external settings, including scientific conferences, regulatory interactions, and partner meetings as needed.
• Other duties as may be assigned.

Job Requirements

• Hands on, high-energy leader who can operate in a fast-paced, entrepreneurial environment.
• Strong computer and Internet skills with proficiency in Microsoft Office (Outlook, Excel, Word, Project & PowerPoint), and ideally project management programs.
• Strong interpersonal and collaborative management skills.
• Outstanding organizational skills.
• Excellent written and oral communication skills.
• Domestic and international travel may be required.
• Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates and externally with third party contract organizations.
• Self-motivated and detail-oriented, with the highest integrity.

Education, Skills and Experience

The ideal candidate will possess significant experience in leading preclinical development programs for cell therapies (such as CAR-T), including the design, execution, and oversight of IND-enabling studies.

Candidate must possess:

• Minimum BSc or equivalent in a relevant scientific discipline; an advanced degree (Ph.D. or MS) in Immunology, Cell Biology, Molecular Biology, or related field is strongly preferred.
• At least 10 years of experience in biotechnology or pharmaceutical R&D, with a focus on preclinical development of CAR T, cell, or gene therapies.
• Deep knowledge of IND-enabling study requirements, including pharmacology and toxicology testing, with demonstrated success in bringing preclinical programs to successful IND clearance.
• Demonstrated ability to manage external collaborations, ensuring quality, timeliness, and budget adherence.
• Solid understanding of GxP requirements, including GLP compliance, and familiarity with regulatory expectations for advanced therapies.

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plan. Optieum Biotechnologies is an equal opportunity employer.

Headquartered in Ehime, Japan, Optieum Biotechnologies, Inc. (www.optieumbio.com) is a pre-clinical stage biotechnology company committed to developing innovative CAR-T cell therapies for treating patients with cancer. Optieum’s proprietary platform technology, the Eumbody System, enables the development of advanced CAR constructs that optimize immune-cell function for oncology targets.