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 :
- 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.
- Coordinate internal research efforts with external partners (CROs, consultants, and academic collaborators) to ensure high-quality, timely, and compliant data generation.
- 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.
