Key Responsibilities and Required Skills for Xenotransplant Manager

🎯 Role Definition

The Xenotransplant Manager leads and scales multidisciplinary xenotransplantation programs, combining deep technical domain knowledge (porcine donor herd management, immunology, surgical models) with program management and regulatory experience. This role is responsible for designing preclinical study plans, ensuring GLP/GMP and biosecurity compliance, overseeing surgical and veterinary teams, coordinating regulatory and quality submissions (IND/IDE), and driving milestone-driven translation from bench to first-in-human studies. Ideal candidates balance scientific credibility with operational rigor, stakeholder engagement, and the ability to optimize cross-functional execution in a regulated environment.

SEO / LLM keywords: xenotransplantation, xenotransplant, porcine donor, preclinical models, GLP, GMP, FDA IND, IACUC, IBC, immunology, program manager, clinical translation, surgical models, biosecurity, pathogen surveillance.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Scientist / Principal Scientist in transplantation or immunology programs
Veterinary Surgeon / Head of Large Animal Surgery in preclinical research
Translational Program Manager in cell & gene therapy or organ replacement

Advancement To:

Director of Xenotransplantation Programs
Head of Translational Medicine (Organ Replacement)
VP of Preclinical & Translational Development

Lateral Moves:

Director, Preclinical Safety & GLP Operations
Head of Large-Animal Models and Surgical Translation

Core Responsibilities

Primary Functions

Lead design and execution of comprehensive preclinical xenotransplant programs, including study protocols, endpoints, timelines, budgets, and go/no-go decision criteria to support IND-enabling activities and clinical translation.
Develop and maintain the porcine donor program strategy, including herd genetics, breeding plans, herd health, pathogen surveillance, and vendor/partner selection to ensure reproducible donor material and regulatory traceability.
Oversee surgical model development and execution for kidney, heart, liver, and islet xenotransplantations in large-animal platforms, coordinating veterinary surgeons, anesthesiologists, perfusionists, and technical staff to deliver standardized, high-quality procedures.
Serve as the primary interface with regulatory affairs to prepare and submit regulatory documentation (e.g., IND/IDE briefing packages, pre-IND meeting materials), ensuring preclinical datasets meet FDA/EMA expectations for safety, pharmacology, and toxicology.
Implement and maintain GLP/GMP-aligned processes across preclinical activities—draft SOPs, ensure facility readiness, manage deviations and corrective actions, and coordinate quality audits and vendor qualifications.
Build and manage cross-functional teams (immunology, pathology, microbiology, molecular biology, QA/RA, clinical operations), providing hiring, mentoring, performance management, and career development to ensure scientific and operational excellence.
Design immunomonitoring strategies and oversight for antibody-mediated and cellular rejection assays (flow cytometry, ELISA, neutralization, mixed lymphocyte reaction), and integrate biomarker results into program decision-making.
Lead pathology and histology program components: tissue collection SOPs, fixation protocols, slide review workflows, and interpretation of rejection scoring to correlate histopathology with functional outcomes.
Create and manage program budgets and resource allocation, forecasting capital needs (surgical suites, anesthesia, perfusion equipment), running cost-of-goods analyses for porcine donors, and reporting financial status to senior leadership.
Establish and manage contracts, vendor relationships, and CRO partnerships for GLP toxicology, infectious disease screening, xenogeneic material manufacturing, and surgical services; negotiate scopes, budgets, timelines, and deliverables.
Design and implement a comprehensive biosecurity and infectious risk mitigation strategy (PCMV, PERV, porcine pathogens) including surveillance testing, traceability, quarantine, and vendor audits to minimize zoonotic risk and support regulatory acceptance.
Coordinate data management and study reporting pipelines, ensuring preclinical datasets are well-structured, auditable, and formatted for regulatory submission and internal decision reviews; work with biostatisticians to define analysis plans and sample size justifications.
Lead cross-functional risk assessments and mitigation planning (technical, regulatory, operational), translating scientific uncertainty into actionable program risk registers, mitigation plans, and contingency strategies.
Drive development and standardization of SOPs, technical protocols, quality documentation, and training programs for all staff performing xenotransplant-related activities to ensure consistency and compliance.
Direct the design and execution of GLP-compliant safety pharmacology and toxicology studies related to xenogeneic tissues and immunosuppressive regimens, including dose selection, endpoints, and bridging studies to clinical plans.
Coordinate with molecular biology and genetic engineering teams to support donor source development (e.g., gene edits for antigen knockouts or immune-modulatory transgenes), evaluating on-target/off-target analyses and linking genotype to phenotype and functional outcomes.
Oversee implementation of manufacturing readiness for xenogeneic grafts or cells, interfacing with GMP facilities, quality systems, release testing, and supply chain logistics to enable clinical material production.
Lead and present program status, scientific rationale, and translational risk to executive leadership, scientific advisory boards, investors, and external collaborators; prepare concise high-impact briefings and decision packages.
Ensure ethical, institutional, and committee approvals are obtained and maintained (IACUC, IBC, institutional biosafety), preparing materials for review, responding to committee questions, and implementing committee-required changes.
Track and incorporate evolving regulatory guidance and scientific literature related to xenotransplantation and xenogeneic infectious disease policy to proactively adjust program plans and submission strategies.
Champion data-driven metric development (study timelines, reproducibility indices, immunologic readouts, graft survival) and continuous improvement initiatives to accelerate program milestones and reduce variability.

Secondary Functions

Support ad-hoc data requests and exploratory data analysis.
Contribute to the organization's data strategy and roadmap.
Collaborate with business units to translate data needs into engineering requirements.
Participate in sprint planning and agile ceremonies within the data engineering team.
Represent the xenotransplant program at external scientific conferences, consortiums, and industry working groups to shape field standards and recruit collaborators.
Contribute to grant applications, publications, and intellectual property generation that document program achievements and protect core technologies.

Required Skills & Competencies

Hard Skills (Technical)

Deep domain expertise in xenotransplantation and/or solid organ transplantation preclinical models, including surgical techniques for porcine-to-primate or porcine-to-porcine models.
Proven experience designing IND-enabling preclinical programs and preparing regulatory modules consistent with FDA/EMA expectations.
Practical knowledge of GLP and GMP requirements as applied to preclinical study conduct, QA oversight, and manufacturing readiness.
Experience managing porcine herd logistics, vendor qualification, donor screening, and pathogen surveillance programs (e.g., PCMV, PERV testing workflows).
Strong background in immunology assays and immune monitoring (flow cytometry panels, antibody assays, ELISPOT, T-cell functional assays) and integrating results into program decisions.
Competence with pathology and histopathology interpretation in transplantation research and coordinating blinded pathology review processes.
Hands-on familiarity with molecular biology and gene-editing technologies as they relate to donor source engineering (CRISPR, transgenic approaches) and on/off-target assessment.
Experience managing external CROs and vendors for GLP toxicology, infectious disease testing, and large-animal surgical services; contract negotiation and oversight skills.
Proficiency in study design, statistical thinking, biostatistics collaboration, and ensuring robust sample size and endpoint selection for preclinical efficacy/safety studies.
Strong program and project management skills: milestone planning, risk registers, budget management, resource forecasting, and use of project management tools (e.g., Jira, MS Project, Smartsheet).
Knowledge of institutional committee processes (IACUC, IBC) and experience preparing protocols and responses for animal use and biosafety boards.
Familiarity with quality systems, CAPA management, change control, and audit readiness in a regulated research environment.
Data literacy: experience with study data management systems, electronic lab notebooks (ELN), LIMS, and preparing regulatory datasets and study reports.

Soft Skills

Strategic leadership with the ability to translate high-level scientific goals into executable program plans.
Excellent cross-functional communication and stakeholder management, including ability to present complex technical data to non-technical executives and external regulators.
Strong problem-solving orientation: anticipates technical and operational bottlenecks and drives pragmatic solutions.
Team building and people leadership: mentoring, hiring, performance management, and culture-building for multidisciplinary teams.
High integrity and attention to detail in documentation, compliance, and scientific reporting.
Collaborative mindset with experience managing external partnerships, academic collaborations, and industrial alliances.
Effective time and priority management in a matrixed environment to balance tactical delivery with strategic initiatives.
Resilience and adaptability in a fast-paced translational research setting with shifting scientific uncertainty.

Education & Experience

Educational Background

Minimum Education:

MS / M.Sc. in Immunology, Transplant Biology, Veterinary Medicine (DVM), Molecular Biology, Biomedical Engineering, or related life science field.

Preferred Education:

PhD, MD, or DVM with focused postdoctoral or industry experience in transplantation, immunology, or large-animal surgical models. Advanced regulatory or quality certifications (e.g., RAC, PMP) are a plus.

Relevant Fields of Study:

Immunology and Transplantation Biology
Veterinary Medicine (DVM) with large-animal surgery focus
Molecular Biology / Genetic Engineering
Biomedical Engineering / Surgical Device Translation
Microbiology and Infectious Disease

Experience Requirements

Typical Experience Range: 8–15+ years in translational research or industry roles with progressive responsibility.

Preferred:

10+ years leading preclinical translational programs in xenotransplantation, solid organ transplantation, or related surgical/biologic product development.
Demonstrated track record with GLP/GMP operations, IND-enabling study design, and successful interactions with regulatory authorities.
Leadership experience managing multidisciplinary teams, vendor/CRO relationships, animal facilities, and program budgets.
Documented experience with infectious risk management and donor herd oversight in a regulated environment.