Key Responsibilities and Required Skills for Xenotransplant Research Director

🎯 Role Definition

The Xenotransplant Research Director will lead end‑to‑end xenotransplantation research and translational programs, directing scientific strategy, designing and executing IND/IDE/CTA‑enabling preclinical studies (porcine models and large animal surgery), supervising gene‑editing and herd characterization efforts, managing GLP/GMP interfaces and vendor partners, and translating immune‑monitoring and engineering solutions into clinical development plans. This role combines deep technical expertise in transplant immunology, gene editing, and large animal science with proven leadership in cross‑functional program delivery, regulatory interactions (FDA/EMA), and budget/resourcing accountability.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Scientist / Principal Investigator in Transplantation Immunology
Director of Immunology or Translational Research at a biotech or academic center
Medical Director or Surgical Lead with large animal xenotransplant experience

Advancement To:

VP of Translational Research / Head of Preclinical Development
Chief Scientific Officer (CSO) for a xenotransplant or regenerative medicine company
Head of Clinical Development or Strategic Program Lead for advanced therapies

Lateral Moves:

Director, Regulatory Strategy (biology-focused)
Director, Cell & Gene Therapy Translational Science

Core Responsibilities

Primary Functions

Define, communicate, and execute the scientific and translational strategy for the xenotransplantation program, including milestones to transition porcine organ and cell products from preclinical proof‑of‑concept to IND/IDE/CTA submission and first‑in‑human studies.
Lead design, oversight, and interpretation of IND/CTA‑enabling GLP and non‑GLP studies in large animal porcine models, including survival surgery, immunosuppression regimens, graft function endpoints, toxicity, and biodistribution assessments to meet regulatory expectations.
Direct gene‑editing programs (e.g., CRISPR/Cas9, TALEN) to generate and characterize multi‑modified donor pigs, establish validation criteria for engineered alleles, and oversee genotyping, off‑target analysis, and herd expansion strategies.
Own immunology and tolerance induction research: design immune monitoring panels (flow cytometry, ELISPOT, cytokine multiplex), develop assays for anti‑porcine antibody responses, cellular rejection profiling, and mechanisms of chronic rejection.
Oversee pathogen screening and zoonotic risk mitigation programs, including PERV testing, porcine virology surveillance, bacteriology, and development/validation of NAT/NGS assays for donor herd safety under GLP/GMP frameworks.
Lead translational assay development and validation: histopathology scoring systems, immunohistochemistry, biomarker development (serologic and tissue), qPCR/NGS assays, and single‑cell immunoprofiling to support regulatory packages and publications.
Manage, mentor, and recruit cross‑functional scientific teams (surgery, veterinary medicine, immunology, molecular biology, bioinformatics) and set performance expectations, development plans, and hiring priorities to meet program timelines.
Serve as primary scientific liaison with regulatory authorities (FDA, EMA), prepare briefing documents, lead pre‑IND/pre‑CTA meetings, and write or contribute substantially to IND/IDE/CTA modules, investigator brochures, and clinical protocols.
Develop and manage program budgets, resource allocation, and vendor relationships (CROs, GLP/GMP manufacturing sites, genomic services) to ensure on‑time and on‑budget delivery of preclinical packages and manufacturing transfers.
Translate preclinical data into clinical development plans: advise on patient selection criteria, clinical endpoints, safety monitoring, stopping rules, and risk mitigation strategies for first‑in‑human xenotransplant trials.
Establish and maintain quality systems and SOPs relevant to xenotransplant research (GLP/GMP interfaces, IACUC compliance, biosafety procedures), audit vendors and internal labs, and remediate non‑conformances related to preclinical or manufacturing activities.
Coordinate surgical teams and veterinary operations to standardize porcine donor procedures, organ procurement protocols, ex‑vivo perfusion and preservation workflows, and post‑operative animal care for reproducible preclinical outcomes.
Design and oversee IND/IDE‑enabling toxicology and safety studies, including dose‑finding, immunosuppression toxicity profiling, off‑target and insertional mutagenesis assessments, and long‑term follow‑up studies to address chronic rejection and zoonotic transmission.
Lead translational manufacturing and process development activities for organ/cell processing under GMP: work with bioprocess engineers and CMOs to define release criteria, sterility, viral clearance, and stability parameters for xenogeneic products.
Drive data strategy and documentation for regulatory submissions: ensure that study reports, raw data packages, assay validation reports, and risk assessments meet regulatory standards and are audit‑ready.
Establish collaborations with academic centers, transplant surgeons, clinical investigators, and consortia to accelerate translational research, share best practices for xenotransplant clinical readiness, and co‑develop multi‑site trial designs.
Lead publications and scientific communications: prepare high‑impact manuscripts, white papers, and conference presentations to build organizational thought leadership and support investor/regulatory communications.
Conduct risk assessments and develop mitigation plans for immunologic rejection, infectious disease transmission, and ethical/public perception risks; coordinate with legal and compliance teams on consent frameworks and public engagement strategies.
Implement and oversee animal welfare and ethical review processes: lead IACUC/ethics committee submissions for complex xenotransplant protocols and ensure humane endpoints, analgesia plans, and veterinary oversight are in place.
Drive continuous improvement in experimental design and statistical rigor by partnering with biostatistics and bioinformatics teams to ensure power calculations, randomization, and blinded readouts for preclinical endpoints.
Manage cross‑functional project planning and tracking: own program Gantt timelines, milestone definitions, go/no‑go decision points, and executive reporting to the C‑suite and board.
Negotiate and manage contracts with CROs, breeding farms, and suppliers of transgenic animals and reagents; ensure SLAs, data ownership, IP, and publication rights are clearly defined and aligned with program objectives.
Provide scientific and operational leadership during crises (unexpected adverse events, regulatory questions, vendor failures), rapidly designing follow‑up studies, root‑cause analyses, and corrective action plans to preserve program integrity.
Mentor and develop junior scientists and veterinary staff through structured training programs and rotational experiences across gene editing, immunology, surgery, and regulatory science to build internal xenotransplant expertise.
Integrate advanced analytics and bioinformatics pipelines to support genomic characterization, immune repertoire analysis, and host–graft interaction modeling that inform target selection and clinical biomarker strategies.

Secondary Functions

Support institutional and program fundraising by preparing scientific pitches, technical due diligence materials, and regulatory summaries for investors and partners.
Contribute to corporate strategy by evaluating external technologies, acquisition/licensing opportunities, and scientific risk/benefit tradeoffs that impact the xenotransplant roadmap.
Participate in external working groups, standards committees, and public outreach to advance safe and ethical adoption of xenotransplantation science.
Provide ad‑hoc scientific review and input for cross‑company initiatives including cell/gene therapy programs, biobanking operations, and advanced analytics projects.
Promote a culture of reproducibility and data integrity by implementing data governance practices and training for lab personnel.

Required Skills & Competencies

Hard Skills (Technical)

Deep expertise in xenotransplantation biology and translational program leadership, including porcine‑to‑human organ and cellular xenotransplant models.
Advanced knowledge of transplant immunology: mechanisms of hyperacute, acute, and chronic rejection and state‑of‑the‑art tolerance induction strategies.
Proven hands‑on experience with gene editing platforms (CRISPR/Cas9, TALEN) and pipelines for multi‑gene engineering of donor animals, including off‑target assessment and transgene validation.
Experience designing and executing GLP and non‑GLP preclinical large animal studies, with demonstrated ability to produce regulatory‑grade study reports.
Demonstrable track record with IND/IDE/CTA regulatory submissions and interactions with FDA/EMA, including leading pre‑IND meetings and compiling module content.
Competence in immunoassays and immune monitoring technologies: flow cytometry, ELISA/Luminex cytokine panels, ELISPOT, single‑cell RNA‑seq, and immune repertoire sequencing.
Strong background in molecular diagnostics and pathogen screening (qPCR, NGS, NAT) for zoonotic risk mitigation and herd surveillance (e.g., PERV testing).
Familiarity with GMP manufacturing requirements for biological products, tech transfer to CMOs, release testing, and quality control of organs/cell products.
Practical experience with surgical protocols and perioperative care in large animal models, organ procurement, ex vivo perfusion and preservation technologies.
Proficiency in study design and biostatistics for translational research: power calculations, endpoints selection, and statistical analysis plans.
Experience managing vendor/CRO relationships and contract negotiation for GLP/GMP services, surgical centers, and breeding/animal husbandry providers.
Working knowledge of ethics, IACUC processes, biosafety, and clinical consent considerations for xenotransplantation trials.

Soft Skills

Strategic scientific leadership with the ability to set clear priorities and drive complex multidisciplinary programs to delivery.
Excellent written and oral communication skills for scientific writing, regulatory documentation, investor presentations, and public outreach.
Cross‑functional collaboration and stakeholder management: ability to align R&D, clinical, regulatory, manufacturing, and commercial teams.
Team building and people management: mentoring, performance feedback, and development of high‑performance research teams.
Strong problem solving and crisis management under regulatory or experimental uncertainty.
Project management, budgeting, and resource planning to meet aggressive timelines and deliverables.
Negotiation skills for contracts, collaborations, and vendor SLAs.
Ethical judgment and public engagement capabilities to address societal concerns about xenotransplantation.
Adaptability to fast‑moving science and shifting regulatory landscapes.
Attention to detail and commitment to data integrity and reproducibility.

Education & Experience

Educational Background

Minimum Education:

PhD in Immunology, Transplantation Biology, Molecular Biology, Veterinary Medicine (DVM), or related life sciences with substantial large animal experience; MD/PhD or DVM/PhD strongly preferred.

Preferred Education:

MD/PhD, DVM/PhD or equivalent advanced degree combined with postdoctoral training in transplantation immunology, gene editing, or large animal surgery.

Relevant Fields of Study:

Transplantation Immunology
Molecular Genetics and Gene Editing
Veterinary Medicine and Large Animal Surgery
Translational Medicine and Regenerative Biology
Bioprocessing / GMP Manufacturing

Experience Requirements

Typical Experience Range: 10+ years in translational research, with at least 5–8 years in xenotransplantation, transplantation immunology, or large animal preclinical development.

Preferred:

12–15+ years with progressive leadership responsibility, demonstrable success delivering IND/IDE enabling packages, hands‑on large animal surgical program management, and prior interactions with regulatory authorities (FDA/EMA). Publication record and prior experience scaling programs through GLP/GMP transition highly desirable.