Lead Clinical Trial

JOB DESCRIPTION

Job title : Lead Preclinical Trial

Reports to :Chief Scientific Officer

Job purpose

This role is critical in driving the design, execution, and interpretation of preclinical studies to support the discovery and development of novel therapeutics for neurological disorders. The ideal candidate will bring deep expertise in neuroscience, pharmacology, and translational science, with a proven track record of advancing drug candidates including biologics, and gene therapies from early discovery through IND-enabling studies.

Duties and responsibilities

• Scientific Lead:

• Lead preclinical strategy and execution for neuroscience drug discovery programs.

• Design and oversee in vivo and in vitro studies to evaluate pharmacodynamics, efficacy, and safety.
• Guide target validation, biomarker development, and mechanism-of-action studies.

• Ability to bridge discovery and translational research, ensuring that preclinical findings inform clinical development.

• Program Management:

• Serve as the preclinical lead on cross-functional project teams.

• Collaborate with medicinal chemistry, DMPK, toxicology, and clinical teams to ensure seamless transition from discovery to development.

• Manage timelines, budgets, and deliverables for preclinical workstreams.

• Team Development:

• Mentor and supervise a team of scientists and research associates.

• Foster a culture of scientific excellence, innovation, and collaboration.

• External Collaboration:

• Identify and manage CROs and academic partnerships to support preclinical research.
• Represent the company at scientific conferences and contribute to publications and patents.
• Regulatory Support:
• Contribute to the preparation of regulatory documents including INDs, IBs, and briefing packages.
• Ensure compliance with GLP and other regulatory standards as needed.
• Program Advancement
• Support IND-enabling studies and contribute to regulatory submissions
• Translate preclinical findings into clinical hypotheses and biomarker strategies

Qualifications

• Ph.D. in Neuroscience, Pharmacology, or a related discipline; postdoctoral experience strongly preferred.
• 8+ years of relevant experience in preclinical drug discovery (industry or translational research).
• Proven track record of leading neuroscience programs to preclinical candidate nomination.
• Expertise in neurobiology, in vivo pharmacology, and translational models of CNS disorders.
• Familiarity with modern neuroscience tools (e.g., optogenetics, imaging, electrophysiology, omics approaches).
• Strong leadership, communication, and project management skills.
• Experience managing and mentoring scientific staff.
• Experience with IND-enabling studies and regulatory documentation.
• Knowledge of biomarker discovery and translational pharmacology.
• Demonstrated success in partnership management (academia or CROs).
• Publication record in high-impact neuroscience or pharmacology journals.

Preferred Experience :

• Neurological animal models: Hands-on experience with rodent models of neurodegenerative, neurodevelopmental disorders, including behavioral, histological, and molecular assessments. In vivo neuroscience expertise: Proficient in designing and executing rodent models of neurodegenerative (e.g., Alzheimers, Parkinsons), neurodevelopmental (e.g., autism, Rett syndrome), and psychiatric disorders (e.g., depression, schizophrenia). Behavioral phenotyping: Skilled in conducting and interpreting behavioral assays such as Morris water maze, open field, rotarod, elevated plus maze, and social interaction tests. Histological and molecular analysis: Experience with immunohistochemistry, in situ hybridization, and quantification of neuroinflammation, synaptic integrity, and neurodegeneration markers. Electrophysiology and imaging: Familiarity with in vivo and ex vivo electrophysiological recordings and neuroimaging techniques (e.g., MRI, PET) for functional assessments.
• Cell-based assays: Proficiency in designing and executing in vitro assays using primary neurons, iPSC-derived cells, or immortalized cell lines to assess target engagement, toxicity, and mechanism of action.
• Drug testing: Experience in evaluating pharmacological agents (small molecules, biologics) in preclinical models, including dose-response, PK/PD, and efficacy studies.
• Gene therapy product testing: Vector design and validation: Understanding of AAV, lentiviral, and non-viral vector systems for CNS-targeted gene delivery. Biodistribution and expression studies: Experience in evaluating transgene expression, vector tropism, and tissue-specific targeting using qPCR, Western blotting, and immunofluorescence. Efficacy and safety assessment: Conducting dose-response, durability, and off-target effect studies in animal models; familiarity with GLP-compliant safety pharmacology and toxicology studies.
• Experience in biotech/pharma settings with IND-enabling studies. Experience in RT-qPCR and data analysis. SDS-PAGE, Immunoblotting, ELISA and antibody binding assays and data analysis. Proficient knowledge in neuroimmunology, synaptic biology, or neurodevelopmental disorders.
• Preclinical data analysis, statistical operations (e.g., ANOVA, t-tests, regression) in preclinical or neuroscience research, graphical representation of data, including power analysis, ANOVA, regression modeling, and multivariate analysis for robust data interpretation. Ability to produce and/or analyze publication-ready data.
• Extensive knowledge of Biomarkers (Identify molecular signatures of disease progression or therapeutic response); Mechanism of Action Studies (Reveal how drugs or gene therapies affect molecular pathways); Target Identification & Validation (Discover novel drug targets through differential expression or pathway analysis).
• Experience with electrophysiology, high-content imaging, or omics-based approaches (Genomics, Proteomics, Transcriptomics and Metabolomics) is a plus.
• Knowledge of emerging modalities (e.g., gene therapy, RNA-based therapeutics, biologics, Antibody-drug conjugates and CAR-T therapies, etc.,).

Working conditions :

This position operates in an office setting, in person. Remote work will be limited.

Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Physical requirements

This is a largely sedentary role.

Direct reports

N/A