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Key Responsibilities and Required Skills for Xenotransplant Research Consultant

💰 $ - $

Life SciencesTranslational ResearchClinical ResearchRegulatory AffairsImmunology

🎯 Role Definition

As a Xenotransplant Research Consultant you will provide subject‑matter expertise in xenotransplantation (porcine-to-human grafts/organs/tissues), guide translational study design, de-risk biologic and infectious safety, and lead regulatory strategies to enable first‑in‑human trials. You will partner with internal R&D, CROs, surgeons, infectious disease and regulatory teams to design GLP/GLP‑like preclinical programs, interpret immunologic and histopathologic endpoints, and translate data into IND/IDE packages and clinical protocols. Strong experience in porcine genetics and genome editing (e.g., CRISPR), immunosuppression strategies, non‑human primate (NHP) models, and viral screening (including PERV) is essential.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Senior Scientist / Principal Scientist – Transplantation Immunology
  • Medical Director / Clinical Research Lead – Transplant Surgery or Infectious Disease
  • Regulatory Affairs Lead with experience in biologics/devices and IND strategy

Advancement To:

  • Head of Translational Medicine / Head of Xenotransplantation Programs
  • Chief Scientific Officer (CSO) for biotech companies developing organ/tissue grafts
  • Vice President, Clinical Development / VP, Regulatory Strategy

Lateral Moves:

  • Translational Scientist – Regenerative Medicine
  • Medical Affairs Director – Cell & Gene Therapy
  • Senior Program Manager – Preclinical Development

Core Responsibilities

Primary Functions

  • Lead design, execution oversight, and interpretation of preclinical xenotransplant studies (porcine organs/tissues into non‑human primates or relevant models), defining primary and secondary endpoints, sample size, and statistical plans to support translational decision‑making and regulatory filings.
  • Develop integrated translational roadmaps that align gene‑edited porcine donor design, immunosuppression regimens, safety testing (including PERV and other porcine‑derived pathogens), and clinical trial entry criteria to minimize biological and regulatory risk.
  • Author and coordinate regulatory submissions (IND/IDE briefing packages, pre‑IND meetings, responses to FDA/EMA/PMDA questions) and translate preclinical datasets into the regulatory narrative required for first‑in‑human studies.
  • Provide expertise in porcine genetics and genome‑editing technologies (CRISPR/Cas, TALENs) to advise on donor modification strategies, off‑target assessment, and functional validation of immunomodulatory transgenes.
  • Design and implement infectious disease and virology safety programs specific to xenotransplantation, including PERV testing strategy, whole genome viral screening, validation of PCR/NGS assays, and development of viral clearance and monitoring plans.
  • Define and monitor immunologic assays (flow cytometry panels, ELISPOT, neutralizing antibody assays, single‑cell immunoprofiling) and histopathology criteria to evaluate graft rejection, tolerance, and immune activation.
  • Establish study protocols and GLP/GLP‑like quality systems for preclinical work, ensuring SOPs, chain of custody, biosecurity, and data integrity for studies that will support regulatory packages.
  • Oversee selection, qualification, and management of CROs, academic partners, and contract laboratories performing NHP studies, histology, immunoassays, and virology testing; negotiate scopes, timelines, and budgets.
  • Serve as primary scientific liaison to transplant surgeons, clinical investigators, pathologists, and infectious disease specialists to ensure clinical feasibility and safety of xenotransplant approaches.
  • Interpret complex immunotoxicology, pathology, and microbiology data; prepare comprehensive study reports, integrated summaries, and data visualizations for internal stakeholders and regulatory agencies.
  • Develop clinical translational biomarker strategies (pharmacodynamic, safety, rejection markers) and recommend validated assays and sampling schedules for early‑phase trials.
  • Lead risk assessment and mitigation planning for zoonotic and porcine‑derived product risks, including donor herd management, sentinel monitoring, and contingency plans for potential pathogen findings.
  • Support manufacturing and quality teams in defining donor source qualification, animal housing and husbandry standards, GMP considerations for porcine tissues, and release testing criteria for xenografts.
  • Collaborate with biostatisticians to define statistical analysis plans for preclinical and first‑in‑human studies; review sample size justifications, interim analyses, and criteria for program advancement.
  • Provide strategic input on clinical protocol design for Phase I/II studies, including inclusion/exclusion criteria, immunosuppression regimens, monitoring schedules, and safety stopping rules tailored to xenotransplant risk profiles.
  • Prepare and deliver scientific briefings, white papers, and internal/external presentations summarizing translational readiness, key milestones, and go/no‑go decisions for senior leadership and investors.
  • Mentor and train cross‑functional project teams on xenotransplant biology, immunologic endpoints, and regulatory expectations; create knowledge transfer materials and technical guidance documents.
  • Support ethics committees and IRBs with background material on xenotransplant risk/benefit, informed consent considerations, and long‑term monitoring plans for recipients.
  • Maintain awareness of evolving regulatory guidance (FDA, EMA, PMDA) and scientific literature on xenotransplantation; proactively update internal policies and development plans to reflect new standards.
  • Lead root‑cause investigations and CAPA activities relating to preclinical study deviations, assay failures, or unexpected biological findings; ensure corrective actions are implemented and documented.
  • Collaborate with commercial and market access teams to provide scientific evidence supporting clinical value propositions, payer discussions, and early HTA inputs for xenotransplant therapies.

Secondary Functions

  • Support ad‑hoc data requests and exploratory data analysis across translational datasets.
  • Contribute to the organization's data strategy and roadmap for integrating multi‑omics, histology, and clinical data.
  • Collaborate with business units to translate data needs into engineering requirements for dashboards and ELNs.
  • Participate in sprint planning and agile ceremonies within the data engineering and translational science teams.
  • Draft grant proposals, investigator brochures, and manuscripts for peer‑reviewed journals to advance the field and company visibility.
  • Support training and development programs for lab personnel and clinical teams on xenotransplant safety protocols and sample handling.
  • Assist with vendor due diligence and procurement for specialized assays, animal models, and bioinformatics pipelines.

Required Skills & Competencies

Hard Skills (Technical)

  • Deep domain expertise in xenotransplantation, xenograft biology, and porcine donor development (porcine genetics, donor herd biosecurity).
  • Experience designing and overseeing NHP preclinical models of organ/tissue xenotransplantation and interpreting immunologic and histopathologic endpoints.
  • Knowledge of genome‑editing tools (CRISPR/Cas9, TALEN) for porcine engineering and experience assessing on‑target/off‑target effects.
  • Virology and pathogen safety expertise, including PERV testing, PCR/NGS assay design, viral surveillance strategies, and infectious disease risk management.
  • Regulatory experience preparing IND/IDE packages, briefing documents, pre‑IND strategy, and responding to agency requests (FDA, EMA, PMDA).
  • Hands‑on knowledge of immunologic assays: flow cytometry, ELISA, ELISPOT, neutralizing antibody assays, Luminex, and single‑cell profiling techniques.
  • Understanding of GLP/GLP‑like study conduct, SOP development, data integrity, and quality systems applicable to preclinical translational programs.
  • Familiarity with GMP considerations for tissue sourcing, manufacturing controls, release testing, and supply chain risks for xenografts.
  • Experience with histopathology review and scoring of rejection, ischemia/reperfusion injury, and chronic graft pathology; ability to integrate pathology with molecular readouts.
  • Strong skills in protocol writing, technical report writing, scientific presentations, and preparing regulatory narratives linked to datasets.
  • Competence with bioinformatics and data analysis workflows for immunogenomics, NGS outputs, and large multimodal datasets; ability to collaborate with biostatistics teams.
  • Project management and CRO oversight skills: vendor selection, contract negotiation, milestone tracking, and budget management.
  • Familiarity with clinical trial design principles for early‑phase safety and feasibility studies (Phase I/II), including safety stopping rules and DSMB interactions.

Soft Skills

  • Strong cross‑functional leadership and stakeholder management with the ability to influence senior leadership and external collaborators.
  • Excellent written and verbal communication tailored to scientific, clinical, regulatory, and commercial audiences.
  • Strategic thinker with experience translating complex science into regulatory and clinical strategies.
  • High ethical standards and sound judgment related to human subjects, zoonotic risks, and long‑term monitoring obligations.
  • Problem‑solving orientation with capacity to lead investigations and implement corrective actions.
  • Collaborative team player who mentors junior scientists and builds consensus across multidisciplinary teams.
  • Adaptability to rapidly evolving science and regulatory landscapes; proactive and resourceful under ambiguity.
  • Strong presentation skills for scientific conferences, advisory boards, and regulatory meetings.
  • Time management and prioritization skills to manage multiple parallel development streams.
  • Negotiation and vendor management skills for collaborating with CROs, academic partners, and suppliers.

Education & Experience

Educational Background

Minimum Education:

  • PhD, MD, MD/PhD or equivalent in Immunology, Transplantation Biology, Virology, Molecular Biology, Biomedical Engineering, or related life sciences fields.

Preferred Education:

  • MD with clinical transplant experience or PhD with a strong translational track record in xenotransplantation or regenerative medicine; additional regulatory or quality certifications (e.g., RAC, PMP) are advantageous.

Relevant Fields of Study:

  • Immunology
  • Transplantation Biology
  • Virology / Infectious Disease
  • Molecular Biology / Genetics
  • Biomedical Engineering
  • Regulatory Science / Translational Medicine

Experience Requirements

Typical Experience Range:

  • 7–15+ years of progressive experience in translational research, preclinical development, or clinical development related to transplantation, cell/gene therapy, or biologics.

Preferred:

  • 10+ years working on xenotransplantation or closely related regenerative medicine programs, with demonstrated leadership of NHP preclinical programs, experience contributing to or leading IND/IDE submissions, and hands‑on experience with immunology, virology (PERV), and genome editing in porcine systems.
  • Proven track record of managing CROs, writing regulatory documents, and interfacing with clinical investigators and regulatory agencies.
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