Director of Preclinical Operations

Position Summary

RadioMedix is seeking an experienced and strategic leader to serve as Director of Preclinical Operations, overseeing the company's Research & Development (R&D) and preclinical functions, including radiochemistry, biology, and in vivo laboratories.

This position is responsible for advancing early-stage radioligand therapy (RLT) and diagnostic candidates through preclinical development toward IND-enabling studies, ensuring programs are executed efficiently, within established timelines and budgets, and in accordance with applicable regulatory and quality standards.

The successful candidate will bring a demonstrated ability to build, lead, and develop high-performing scientific teams while establishing scalable, GLP-compliant laboratory operations. This individual will drive laboratory modernization through technology, systems, and process improvements while maintaining high standards for scientific integrity, radiation safety, regulatory compliance, and laboratory organization.

About RadioMedix

RadioMedix is a Houston-based, clinical-stage radiopharmaceutical company focused on developing targeted diagnostic and radioligand therapeutic products for cancer and other serious diseases. The company's work spans discovery, preclinical development, clinical studies, and manufacturing, with programs utilizing radioisotopes such as Pb-212, Ga-68, and Cu-64.

Key Responsibilities

1. Team Leadership and Organizational Development

• Lead, recruit, develop, and retain multidisciplinary R&D and preclinical teams, establishing clear objectives, priorities, and performance expectations.

• Foster a culture of scientific excellence, accountability, collaboration, operational ownership, and radiation safety.

• Provide leadership, coaching, and professional development to managers, scientists, and technical personnel.

• Establish performance management practices, conduct employee evaluations, and support succession planning and career development.

• Evaluate staffing needs, allocate resources, and balance workloads across concurrent research and development programs.

• Establish accountability for departmental performance, productivity, and achievement of organizational objectives.

2. Laboratory Operations and Management

• Oversee the daily operations of radiochemistry, cell biology, and in vivo (vivarium) laboratories.

• Manage laboratory budgets, capital expenditures, equipment procurement, maintenance, calibration, and inventory management.

• Coordinate isotope procurement, supply planning, and delivery schedules to support research and preclinical study timelines.

• Ensure compliance with applicable radioactive materials licenses, ALARA principles, dosimetry requirements, and radioactive waste management practices in collaboration with the Radiation Safety Officer (RSO).

• Oversee animal research activities and ensure compliance with approved IACUC protocols and applicable AAALAC or OLAW standards, where applicable.

• Establish and maintain standardized operating procedures (SOPs), data integrity practices, electronic laboratory documentation, and inspection-ready records.

• Identify and implement opportunities to improve laboratory efficiency, resource utilization, operational performance, and cost management.

3. Laboratory Standards, Organization, and Housekeeping

• Establish and enforce consistent standards for laboratory cleanliness, organization, safety, and housekeeping across all laboratory, hot cell, and vivarium areas.

• Assign designated managerial ownership for individual laboratory areas and establish clear accountability for maintaining operational standards.

• Implement routine laboratory inspections, cleaning schedules, contamination surveys, and corrective action processes.

• Ensure deficiencies are documented, addressed, and resolved in a timely manner.

• Maintain continuous inspection readiness for radiation safety reviews, IACUC assessments, GLP inspections, and external partner or client audits.

4. GLP Implementation and Regulatory Readiness

• Lead the implementation and ongoing development of Good Laboratory Practice (GLP) standards in accordance with FDA 21 CFR Part 58, progressing from initial gap assessment through operational implementation.

• Establish the necessary GLP infrastructure, including study director and test facility management responsibilities, controlled SOPs, study protocols, amendments, training records, equipment qualification and calibration documentation, and archival procedures.

• Partner with an independent Quality Assurance (QA) function to establish study auditing procedures, facility inspections, documentation requirements, and a GLP master schedule.

• Identify which preclinical studies can be conducted internally under GLP requirements and which should be outsourced to qualified contract research organizations (CROs).

• Develop implementation timelines, resource requirements, and budgets to support GLP readiness.

• Ensure laboratory practices, study documentation, and data management processes support regulatory submissions and inspection requirements.

5. Laboratory Technology, Systems, and Modernization

• Evaluate existing laboratory systems and lead the selection, implementation, and optimization of technology platforms, including laboratory information management systems (LIMS), electronic laboratory notebooks (ELN), sample and isotope inventory tracking, equipment scheduling, and imaging and dosimetry analysis tools.

• Ensure computerized systems and electronic records meet applicable data integrity requirements and FDA 21 CFR Part 11 standards, where required.

• Lead technology adoption through employee training, change management, and ongoing system utilization monitoring.

• Identify opportunities to incorporate automation, advanced assay technologies, imaging capabilities, and data analytics, including artificial intelligence (AI), to improve research quality, efficiency, and operational performance.

• Establish scalable systems and processes that support the company's anticipated growth and evolving R&D requirements.

6. Preclinical Program Development and Execution

• Direct the design and execution of preclinical development programs for radioligand therapeutics and companion diagnostics.

• Oversee key preclinical activities, including binding and internalization assays, radiolabeling optimization, stability testing, biodistribution, SPECT/PET imaging, efficacy assessments, dosimetry, and toxicology.

• Translate scientific and business objectives into structured development plans with defined milestones, budgets, timelines, and go/no-go criteria.

• Identify, select, and manage CROs and academic collaborators, including oversight of GLP toxicology studies, scopes of work, budgets, deliverables, and data quality.

• Author and review preclinical sections of IND, IMPD, and other applicable regulatory submissions.

• Support regulatory interactions and responses to inquiries from the FDA and other regulatory authorities.

• Monitor program performance, identify potential risks, and provide timely updates and recommendations to executive leadership.

• Ensure preclinical programs remain aligned with corporate development priorities and strategic objectives.

7. Cross-Functional Collaboration and Business Support

• Collaborate with CMC, manufacturing, quality, regulatory affairs, and clinical teams to facilitate the progression of development candidates from discovery through first-in-human studies.

• Support business development and strategic partnership activities through technical due diligence, scientific presentations, and preclinical program assessments.

• Provide technical oversight and support for collaborative research initiatives and CDMO-related client projects, where applicable.

• Contribute to grant applications, scientific publications, and presentations at industry conferences.

• Evaluate emerging targets, chelators, linkers, and radioisotopes to support pipeline expansion and scientific innovation.

• Provide scientific and operational recommendations to executive leadership regarding R&D priorities, resource allocation, and investment opportunities.

Qualifications

Education

• PhD in Radiochemistry, Nuclear Medicine, Pharmacology, Molecular Imaging, Cancer Biology, or a related scientific discipline.

• A Master's degree combined with substantially greater relevant industry experience may be considered.

Professional Experience

• Minimum of 10 years of pharmaceutical or biotechnology drug development experience, including at least 5 years in radiopharmaceutical development.

• Demonstrated experience advancing radioligand therapeutics (RLTs) or theranostic agents through preclinical development, preferably through IND submission.

• Direct experience working within GLP environments, including involvement in establishing, implementing, or maintaining GLP-compliant laboratory operations or study programs.

• Experience managing CRO relationships, overseeing GLP studies, and contributing to IND or equivalent regulatory submissions.

• Working knowledge of radiolabeling, biodistribution, SPECT/PET imaging, and dosimetry studies.

Leadership and Operational Experience

• Minimum of 5 years of progressive leadership experience managing multidisciplinary scientific teams, including experience managing managers.

• Demonstrated success leading scientific programs, building and retaining high-performing teams, and scaling or improving laboratory operations.

• Proven ability to manage laboratory operations, including budgets, staffing, equipment, maintenance, housekeeping, safety, and regulatory compliance.

• Experience establishing performance expectations, operational procedures, and accountability across scientific and technical teams.

• Demonstrated experience selecting, implementing, or optimizing laboratory software and technology systems, such as LIMS or ELN platforms.

• Ability to lead organizational change and implement operational improvements that support business growth and scientific objectives.

Technical and Professional Skills

• Working knowledge of radiation safety regulations, NRC or Agreement State licensing requirements, ALARA principles, dosimetry, and radioactive waste management.

• Understanding of GLP requirements, FDA regulations, data integrity standards, and applicable electronic records requirements.

• Ability to evaluate emerging scientific, technological, and regulatory developments and translate them into practical operational improvements.

• Strong organizational, analytical, and problem-solving capabilities.

• Excellent written and verbal communication skills, with the ability to present complex scientific and operational information to employees, executive leadership, external partners, and regulatory authorities.

Preferred Qualifications

• Experience working with both alpha- and beta-emitting radioisotopes.

• Background in therapeutic and diagnostic radiopharmaceutical development, including theranostic pairs.

• Experience building, restructuring, or scaling a preclinical R&D function within a growing biotechnology or pharmaceutical organization.

• Previous experience serving as a GLP Study Director or Test Facility Management representative, or leading a laboratory through a GLP inspection or audit.

• Experience with FDA 21 CFR Part 11 validation of computerized systems, laboratory automation, or implementation of data analytics and AI tools in research environments.

• Exposure to CMC, GMP manufacturing, or CDMO operations, including an understanding of how preclinical development decisions affect manufacturing scale-up.

• Experience supporting business development, technical due diligence, strategic partnerships, or fee-for-service preclinical programs.

• Established publication record in radiopharmaceutical science and active professional involvement in the nuclear medicine community, such as SNMMI.