Xenotransplant Research Manager — Key Responsibilities & Required Skills

🎯 Role Definition

The Xenotransplant Research Manager is an experienced scientific and operational leader responsible for designing, executing and managing preclinical xenotransplantation programs. This role leads cross-functional teams (surgery, veterinary medicine, immunology, pathology, manufacturing and regulatory) to develop and de-risk porcine-derived organ and cellular xenograft models, ensuring GLP/GMP-compliant study design, rigorous data collection and timely submission-ready deliverables for IND-enabling and clinical translation. The ideal candidate combines deep technical expertise in transplant immunobiology and surgical models with hands-on program management, vendor oversight, and regulatory experience (IACUC, IBC, FDA/EMA interactions).

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Research Scientist, Transplant Immunology
Veterinary Surgeon / Laboratory Animal Veterinarian with research management experience
Project Lead, Preclinical or Translational Medicine (cell/gene/organoid)

Advancement To:

Director of Translational Xenotransplantation / Head of Preclinical Development
Senior Director, Translational Medicine or Clinical Development (Solid Organs)
VP, Preclinical & Translational Sciences

Lateral Moves:

Program Manager, Advanced Therapies (cellular & gene)
Head of Comparative Pathology and Translational Endpoints

Core Responsibilities

Primary Functions

Lead end-to-end xenotransplantation study design and execution, including selection and development of porcine donor models, surgical protocols (orthotopic and heterotopic grafting), perioperative care, and study endpoints to meet IND-enabling objectives.
Manage and mentor a multidisciplinary team of scientists, veterinarians, surgeons, research associates and technicians to ensure consistent, reproducible surgical models and high-quality preclinical data supporting clinical translation.
Develop and implement immunosuppression and tolerance-induction strategies for porcine-to-primate and porcine-to-human xenograft models, coordinate dosimetry, PK/PD studies, and optimize regimens in collaboration with immunology teams.
Drive translational assay development and validation (flow cytometry panels, ELISAs, neutralizing antibody assays, qPCR/ddPCR for porcine endogenous retroviruses, cytokine multiplex assays) to monitor cellular and humoral immune responses to xenografts.
Oversee pathology and histopathology programs for graft evaluation (rejection scoring, immunohistochemistry, in situ hybridization), including coordination with external pathology CROs and internal comparatives for lesion quantitation.
Establish and enforce GLP/GCP-like quality systems for preclinical xenotransplant studies, including SOP creation, study documentation, data integrity practices and audit readiness.
Lead regulatory strategy and interactions for xenotransplant programs — prepare briefing packages, contribute to pre-IND and IND materials, address FDA/EMA questions relating to donor source, gene edits, infectious risk and manufacturing controls.
Coordinate animal care and compliance oversight with IACUC and IBC, ensuring all xenotransplant procedures, animal housing, biocontainment and biosafety policies meet institutional and national standards.
Manage vendor selection, contracting and day-to-day oversight for critical external partners (gene-edited pig providers, CROs for surgical models, GMP manufacturing sites for tissues/organs, specialized assay vendors).
Drive program milestones, resource allocation and timelines across multiple concurrent studies to meet strategic translational objectives, escalating risks and implementing mitigation plans proactively.
Control program budgets, forecast spend for animal models, surgical supplies, vendor services and capital equipment; report financial status to senior leadership and optimize cost-efficiency without compromising data quality.
Lead infectious disease risk assessment and surveillance programs (porcine endogenous retrovirus screening, adventitious agents, viral vector shedding) and coordinate mitigation strategies including quarantine, PCR monitoring and sentinel programs.
Design and implement telemetry and continuous physiologic monitoring workflows for post-operative graft function assessment (hemodynamics, organ-specific biomarkers, oxygenation and perfusion metrics).
Oversee ex vivo perfusion and organ preservation protocols (normothermic and hypothermic machine perfusion) and collaborate with perfusion engineering teams to optimize organ quality prior to transplantation.
Implement and maintain a centralized data management strategy for translational studies — ensure standardized data capture, metadata, LIMS integration, secure repositories and compliance with FAIR principles to support reproducible research.
Partner with manufacturing (GMP) teams to align donor animal herd management, tissue procurement SOPs, and supply chain controls required for clinical-grade xenograft material.
Translate complex preclinical results into high-quality scientific reports, regulatory study reports, and clear slide decks for leadership, investigators and regulatory submissions.
Drive publication and scientific communication strategy — author and co-author manuscripts, present data at scientific conferences and engage with external academic and clinical collaborators.
Provide technical expertise on gene-editing strategies (CRISPR/Cas, targeted knockouts/knockins) used to reduce antigenicity and modulate coagulation/complement pathways in donor animals; coordinate with genetic engineering partners.
Coordinate humane endpoints, analgesia, perioperative protocols and long-term welfare monitoring in compliance with veterinary best practices and ethical frameworks.
Lead cross-disciplinary meetings and steering committees to align scientific hypotheses, study design, and translational go/no-go criteria across immunology, safety, manufacturing and regulatory functions.
Establish and track key performance indicators (KPIs) for preclinical program health (study timelines, assay reproducibility, animal survival, graft function metrics) and implement continuous improvement initiatives.
Ensure biosafety and biosecurity controls specific to xenotransplantation are implemented and audited, including PPE, containment levels, waste management and staff training programs.
Serve as the primary point of contact for clinical investigators and external collaborators to plan first-in-human translation, bridging preclinical endpoints to clinical trial design and inclusion/exclusion criteria.

Secondary Functions

Support ad-hoc translational data requests, exploratory biomarker analyses and retrospective charting of preclinical endpoints to inform study refinement.
Contribute to the organization's broader xenotransplant strategy and roadmap, identifying technical gaps, prioritizing de-risking experiments and recommending resource allocation.
Collaborate with clinical development, regulatory affairs and manufacturing to translate preclinical results into clinical protocols and regulatory submissions, ensuring alignment on endpoints and controls.
Participate in project sprint planning, program governance meetings and agile-style prioritization focused on delivering IND-enabling datasets and operational readiness.
Support training programs for surgical technique transfer, SOP compliance and biosafety for internal staff and partner sites.

Required Skills & Competencies

Hard Skills (Technical)

Deep domain expertise in xenotransplantation and transplant immunobiology (porcine models, xenografts, immune rejection mechanisms, tolerance induction).
Proven experience designing and leading preclinical surgical models (orthotopic/heterotopic organ transplantation; large animal surgery).
Hands-on knowledge of immunology assays: multi-parameter flow cytometry, ELISA, neutralizing antibody assays, cytokine multiplex, and single-cell immunophenotyping.
Molecular virology and pathogen surveillance skills including qPCR, ddPCR and NGS for detection/surveillance of porcine endogenous retroviruses and adventitious agents.
Pathology and histopathology interpretation experience specific to graft rejection, complement activation and thrombotic microangiopathy; familiarity with IHC and ISH workflows.
Experience with ex vivo organ perfusion systems, organ preservation science, and physiologic monitoring instrumentation and telemetry.
Regulatory experience preparing pre-IND/IND documentation, responding to regulatory queries, and interfacing with FDA/EMA on preclinical safety and donor-source risk.
Practical knowledge of GLP/GMP quality systems, SOP development, audit readiness, and study documentation for IND-enabling studies.
Familiarity with gene-editing strategies (CRISPR/Cas) in donor animals and implications for immunogenicity and safety assessment.
Strong data management literacy: LIMS, ELN, centralized data repositories, basic biostatistics and data visualization to interpret translational endpoints.
Budget, contract and vendor management experience negotiating CRO/CMO agreements and managing external deliverables.
Animal welfare, IACUC and biosafety compliance expertise, including experience with IBC and containment practices for xenogeneic materials.

Soft Skills

Exceptional program and project management skills with the ability to prioritize, set timelines and drive cross-functional execution in a fast-paced translational environment.
Strong leadership and people-management skills: hiring, mentoring, coaching and developing high-performing scientific teams.
Influential communicator able to translate complex preclinical science to leadership, regulatory authorities, clinicians and non-technical stakeholders.
Collaborative mindset with demonstrated success building and maintaining partnerships across internal functions and external academic/industry collaborators.
Problem-solver with a pragmatic, data-driven approach, comfortable making decisions under uncertainty and rapidly adjusting experiments to preserve timelines.
Meticulous attention to detail and commitment to scientific rigor, reproducibility and data integrity.
Effective negotiator and vendor manager who can secure favorable terms while ensuring technical deliverables.
Resilient, adaptive and comfortable operating within regulatory and ethical constraints inherent to xenotransplantation research.

Education & Experience

Educational Background

Minimum Education:

MS or advanced degree (PhD, DVM or MD preferred) in Immunology, Transplantation Biology, Veterinary Medicine, Surgery, Molecular Biology or related biomedical sciences.

Preferred Education:

PhD, MD, DVM or equivalent with postdoctoral or clinical research experience in transplantation, immunology, or large-animal surgical models.

Relevant Fields of Study:

Immunology / Transplant Immunology
Veterinary Medicine / Comparative Surgery
Molecular Biology / Virology
Biomedical Engineering (organ perfusion/physiology)
Pathology / Comparative Pathology

Experience Requirements

Typical Experience Range: 7–15+ years in preclinical/translational research with at least 3–5 years leading cross-functional teams and managing large-animal or xenotransplantation programs.

Preferred:

Prior hands-on experience running porcine xenotransplant or pig-to-nonhuman-primate models and documented success delivering IND-enabling studies.
Demonstrated track record interacting with regulatory agencies (pre-IND/IND), managing IACUC/IBC processes, and publishing peer-reviewed translational research.
Experience with GLP/GMP-compliant study execution, vendor/CRO/CMO management and budget ownership.