Key Responsibilities and Required Skills for Xenograft Manager

🎯 Role Definition

The Xenograft Manager is a hands‑on preclinical leader responsible for designing, executing and managing xenograft and patient‑derived xenograft (PDX) studies to support oncology drug discovery and development. This role combines technical expertise in tumor model establishment (subcutaneous, orthotopic, metastatic), in‑vivo dosing and monitoring, and tissue processing with operational leadership — including SOP development, study budgeting, vendor management, regulatory compliance (IACUC, GLP/GCLP where applicable), and cross‑functional communication with pathology, pharmacology and discovery teams. The ideal candidate ensures reproducible, high‑quality tumor growth and pharmacology data, mentors technical staff, and continuously improves processes to accelerate go/no‑go decisions.

📈 Career Progression

Typical Career Path

Entry Point From:

In Vivo Technician / In Vivo Research Associate with oncology model experience
Preclinical Study Coordinator or Animal Technologist (AALAS certified)
Cell Culture/Biology Research Associate with tumor implantation exposure

Advancement To:

Senior Xenograft Manager / Lead, In Vivo Oncology
In Vivo Pharmacology Study Director
Senior Manager, Preclinical Development or Director, In Vivo Sciences

Lateral Moves:

Pathology & Tissue Analysis Manager
Vivarium Operations Manager
Translational Biology Project Lead

Core Responsibilities

Primary Functions

Lead the design, implementation and day‑to‑day management of xenograft and PDX study portfolios, including study protocol development, cohort sizing, randomization strategies, and statistical endpoints to support efficacy and tumor biology readouts.
Establish and optimize subcutaneous, orthotopic and metastatic xenograft implantation techniques (cell line and PDX), ensuring reproducible tumor take‑rates, growth kinetics and model fidelity across studies and technicians.
Oversee dosing operations (oral gavage, i.v., i.p., s.c., osmotic pumps) and sample collection schedules, ensuring precise dose preparation, administration records, chain of custody and alignment with PK/PD study designs.
Supervise tumor measurement procedures (caliper, ultrasound, bioluminescence/IVIS imaging), data capture and QC workflows to produce reliable tumor growth curves, tumor volume calculations and time‑to‑endpoint metrics.
Design and implement humane endpoint criteria and clinical scoring, manage moribund animal decisions, and ensure compliance with IACUC protocols, institutional policies and animal welfare best practices.
Develop, maintain and continuously improve SOPs, study manuals, and training materials for xenograft implantation, perioperative care, dosing, biopsy, euthanasia and necropsy procedures to standardize operations.
Manage onboarding, performance development and task allocation for in‑vivo team members and technicians; provide hands‑on training in surgical aseptic technique, anesthesia, analgesia and post‑operative care.
Coordinate integrated study execution with pathology, histology, flow cytometry, bioanalysis and imaging teams to secure timely tissue processing, fixation, staining and biomarker analysis aligned with study endpoints.
Lead vendor selection and oversight for outsourced PDX generation, cryopreservation, imaging services or specialized PK/PD assays; negotiate scopes, timelines, budgets and quality agreements.
Ensure accurate, auditable study documentation and data management practices, including electronic study records, raw data archival, deviation reporting and data handover for statistical analysis and regulatory review.
Drive implementation of GLP/GCLP best practices for preclinical oncology studies when required; prepare for audits and contribute to corrective action plans and continuous improvement initiatives.
Interpret study results, draft study reports, DMC summaries and technical write‑ups that clearly communicate tumor growth inhibition, percent tumor growth delay, response rates and pharmacodynamic biomarker changes to cross‑functional stakeholders.
Partner with discovery scientists and pharmacologists to translate target biology into relevant tumor models, prioritize in vivo experiments, and design go/no‑go decision frameworks that optimize portfolio resource allocation.
Plan, manage and report study budgets, resource forecasting and timelines; escalating risks early, mitigating operational bottlenecks and ensuring on‑time data delivery for program milestones.
Lead troubleshooting and root cause analyses for unexpected model failures (e.g., variable take rate, high perioperative mortality, inconsistent tumor growth), implementing process changes and retraining as needed.
Oversee tissue procurement, processing and storage workflows (fixed, frozen, OCT), ensuring sample traceability and appropriate archival for downstream histopathology, IHC, RNA/DNA extraction and sequencing.
Implement and maintain metrics and KPI dashboards for model performance, study throughput, animal welfare indicators and reagent/inventory status to support data‑driven management decisions.
Ensure biosafety, hazardous material handling and shipping compliance for tumor cells, xenograft tissue and biological samples, coordinating with institutional biosafety and shipping teams.
Lead pilot model characterization studies (growth kinetics, histopathology, biomarker expression, immune infiltrate profiling) to qualify new PDX or syngeneic lines and recommend model fit for mechanistic or efficacy studies.
Collaborate with regulatory, quality and clinical translation teams to align preclinical model data packages with IND‑enabling strategies and translational biomarker plans.
Drive technology adoption (digital caliper integrations, LIMS, electronic lab notebooks, automated imaging) to improve accuracy, reproducibility and scale of xenograft operations.

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.
Act as subject matter expert for cross‑functional teams to educate discovery and translational teams on limitations and capabilities of xenograft and PDX models.
Represent the in‑vivo group in cross‑site collaborations and external scientific meetings, presenting model validation data and study outcomes to internal and external audiences.
Mentor junior scientists on experimental design, statistical considerations and humane animal handling to grow internal technical capability.
Maintain reagent, cell line and cryobank inventories, and ensure authentication and mycoplasma testing are performed and documented for xenograft source materials.

Required Skills & Competencies

Hard Skills (Technical)

Expertise in establishing and running xenograft, orthotopic and metastatic tumor models (cell line and PDX) with documented reproducibility.
Hands‑on surgical skills for tumor implantation and biopsy procedures, with proficiency in aseptic technique, anesthesia and perioperative care.
Strong knowledge of in vivo dosing routes and dose formulation, including oral gavage, intravenous injection, intraperitoneal injection and osmotic pump implantation.
Experience with tumor monitoring technologies: caliper measurements, IVIS/bioluminescence, ultrasound, and basic image analysis for tumor burden quantification.
Familiarity with pharmacokinetic (PK) and pharmacodynamic (PD) study design, sample collection schedules and interpretation of exposure‑response relationships.
Proficiency in tissue processing workflows: grossing, fixation, paraffin embedding, cryopreservation, IHC, and coordinating histopathology readouts.
Working knowledge of regulatory and compliance frameworks: IACUC protocol development, GLP/GCLP principles, biosafety and animal welfare standards.
Strong documentation and electronic data management skills: LIMS, ELNs, study databases and generation of audit‑ready study records and final reports.
Experience with model qualification metrics, statistical power calculations, and designing studies with appropriate controls and randomization/blinding.
Familiarity with molecular and cellular assays commonly linked to xenograft studies: qPCR, Western blotting, flow cytometry, and biomarker multiplex assays.
Experience managing outsourced vendors for PDX services, contract labs and specialized imaging with ability to assess vendor QC and study deliverables.
Practical knowledge of cryopreservation, cell line authentication and contamination prevention (mycoplasma testing).

Soft Skills

Strong leadership and people management skills with experience building and coaching technical teams.
Excellent written and verbal communication skills to clearly summarize complex in vivo data for scientific and non‑scientific stakeholders.
Highly organized and detail‑oriented with the ability to manage multiple concurrent studies and shifting priorities.
Problem‑solving mindset with the ability to run root cause analyses and implement process improvements.
Cross‑functional collaboration skills; proven ability to work with discovery, translational, pathology and quality teams.
Mentor and trainer — comfortable delivering hands‑on training and competency assessments for lab personnel.
Strategic thinker who can align model development with program timelines and go/no‑go decision frameworks.
Data‑driven decision maker with a bias for documentation and reproducibility.

Education & Experience

Educational Background

Minimum Education:

Bachelor of Science (B.S.) in Biology, Molecular Biology, Pharmacology, Biomedical Science, or related life sciences discipline.

Preferred Education:

Master’s (M.S.) or Ph.D. in Oncology, Pharmacology, Molecular Biology, or Veterinary Science preferred for senior roles; or equivalent combination of education and demonstrated on‑the‑bench xenograft experience.

Relevant Fields of Study:

Oncology / Cancer Biology
Pharmacology / Toxicology
Molecular and Cellular Biology
Veterinary Medicine / Comparative Medicine
Translational Medicine

Experience Requirements

Typical Experience Range: 3–8 years of progressive in‑vivo oncology and xenograft model experience; 5+ years preferred for manager roles.

Preferred:

5+ years directly managing xenograft or PDX programs in biopharma, CRO or academic translational labs.
Experience with IACUC protocol authorship and approvals, GLP or GCLP exposure, and participation in preclinical regulatory packages.
AALAS certification (ALAT, LAT, LATG) or equivalent vivarium certification is highly desirable.
Track record of developing new models, scaling study throughput, and delivering high‑quality preclinical datasets that advanced programs into IND or clinical development.