TCS Medical Officer

The TCS Medical Officer leads medical office engagement with Therapeutic Apheresis and Cellular Therapeutics programs, providing expert clinical oversight and consultation. The role involves collaborating with leadership for program development, regulatory compliance, and advancing clinical services in cellular therapies and transfusion medicine.

Responsibilities

• Direct medical strategy and operations for regulated cellular therapies (HPCs, CAR-T, Leukopaks), including policy development for cell collection, storage, and infusion.
• Partner with executive leadership to expand collection footprints and optimize the production of specialized cellular products like CAR-T starting materials.
• Contribute towards the expansion of cellular services through targeted outreach, partnerships, new program development, and support of sales teams as required.
• Serve as the program’s medical office representative at institutional, regional, and national committees.
• Act as the primary medical liaison for biotech partners, providing expert guidance on donor eligibility, product specifications, and clinical trial alignment.
• Provide medical oversight for the transfer of client-specific protocols from research to clinical-grade production.
• Investigate and resolve donor/recipient concerns, transfusion issues, and service complaints with timely leadership notification.
• Provide medical consultation in transfusion medicine, blood banking, and patient services to hospital clients, fostering strong and collaborative relationships.
• Oversee medical aspects of regulated blood center operations including donor management, recipient adverse reactions, and product investigations.
• Provide oversight as CLIA laboratory director for a regional immunohematology reference laboratory, as applicable.
• Contribute to the development of policies and procedures related to donor eligibility, component quality, and transfusion practices.
• Deliver continuing medical education to internal and external audiences, promoting safe and effective use of blood components.

Requirements

• MD/DO with Board Certification in Transfusion Medicine or Hematology/Oncology.
• Preference for a minimum of 5 years’ experience in Cell Therapy and Hematopoietic Stem Cell Transplantation, but negotiable.
• Proven experience with FACT (Foundation for the Accreditation of Cellular Therapy) accreditation processes and AABB Standards for cellular therapy.
• Knowledge of FDA regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps).
• Demonstrate prior leadership experience in program development, with knowledge of cellular therapy regulations, transplant protocols, and regulatory (e.g. FACT) accreditation process.
• Demonstrate ability to lead strategic growth, manage multidisciplinary teams, and maintain compliance with FACT, CLIA, and FDA standards.
• Experience leading or overseeing investigator-initiated clinical trials or translational research in cellular immunotherapy is of interest but not required.
• Combination of candidate’s education and general experience satisfies requirements so long as the total years equate to description’s minimum education and general experience years combined (Management experience and certifications cannot be substituted).

Skills

• Transfusion Medicine
• Hematology/Oncology
• Cell Therapy
• Hematopoietic Stem Cell Transplantation
• FACT Accreditation
• AABB Standards
• FDA Regulations
• Cellular Therapy Regulations
• Transplant Protocols
• Program Development
• Strategic Growth Leadership
• Interdisciplinary Team Management
• Regulatory Compliance
• CLIA Requirements
• Clinical Trials Oversight
• Translational Research
• Cellular Immunotherapy
• Therapeutic apheresis
• Clinical Consultation Services

Languages

English