Associate Director/Director, Biology - CNS/Neurological disease
Associate Director / Director, Biology About Mentari Therapeutics Mentari Therapeutics is a biopharmaceutical company developing a potentially best-in-class portfolio of targeted biologics for migraines, one of the most widespread and undertreated neurological conditions. The arrival of anti-CGRP therapies marked a turning point in migraine care, but a significant unmet need remains, with a majority who suffer unable to achieve adequate relief. Mentari's two lead programs target PACAP, a newly validated, distinct pathway in migraine biology. MT-001 is a potentially best-in-class anti-PACAP antibody, and MT-002 is a bispecific antibody designed to block both CGRP and PACAP, with the potential to provide superior efficacy compared to either monotherapy alone. Our mission is to bring about a new era in migraine treatment for the more than 1 billion suffering globally. For more information, please visit www.mentaritx.com. Position Overview Mentari Therapeutics is seeking an Associate Director or Director, Biology to lead translational neuroscience efforts in support of our development pipeline. The successful candidate will focus on preclinical biology to enable Clinical Development, designing and interpreting translational models that inform program-specific decisions and enable regulatory milestones. The position requires a scientist with strong regulatory literacy and the ability to drive nonclinical packages from candidate nomination through Phase 2 decision points.
Key Responsibilities
Translational Model Design & Execution ● Design, execute, and interpret nonclinical in vitro and in vivo models relevant to CNS/neurological indications. ● Integrate nonclinical biology data with efficacy, safety, and DMPK/PK-PD datasets to build a coherent translational narrative for each program. ● Oversee CRO-conducted nonclinical biology studies; ensure scientific integrity, timeline adherence, and data quality across external collaborations. ● Define translational endpoints in preclinical models (pharmacodynamic, target engagement, disease modification). Development-Stage Nonclinical Leadership ● Own the nonclinical biology component of IND filings and ongoing regulatory submissions; author pharmacology and efficacy sections of regulatory dossiers. ● Develop nonclinical study plans aligned with FDA, EMA, and ICH expectations for CNS development programs; actively monitor guidance updates relevant to Mentari's indications. ● Partner with Clinical Development and Biomarkers/Translational Medicine functions to ensure continuity from bench to Phase 2. Cross-Functional Contribution ● Present nonclinical biology data and translational rationale at project team meetings, governance reviews, and partner/investor interactions. ● Collaborate with Regulatory Affairs on agency briefing documents and responses to health authority questions on nonclinical biology. ● Evaluate external collaboration opportunities (academic partnerships, CRO capabilities) to augment internal translational capacity.
Qualifications
Required ● Ph.D. in neuroscience, pharmacology, or a directly related discipline. ● 5–10+ years of nonclinical biology experience in pharmaceutical or biotech drug development, with a CNS or neurological disease focus. ● Demonstrated track record of translational model development and application in a development (not purely research) context. ● Experience contributing to IND or regulatory submissions, including authoring nonclinical pharmacology or efficacy sections. ● Strong command of in vivo experimental design, PK-PD concepts, and biomarker strategy in CNS indications. ● Experience designing, managing, and interpreting outsourced in vivo studies. Preferred ● Direct experience with FDA or EMA regulatory interactions on nonclinical CNS matters. ● Familiarity with biomarker-informed trial design and early clinical-translational collaborations. ● Experience working with biologics in neurological indications.