Senior Director and head of DMPK & Bioanalytical

Senior Director and head of DMPK & Bioanalytical

About Tonix*

Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first‑in‑class, once‑daily, non‑opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement.

Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® Sym Touch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults.

Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno‑oncology, infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases.

Finally, rare disease portfolio includes a product in development for Prader‑Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA.

Tonix owns and operates a state‑of‑the‑art infectious disease research facility in Frederick, Md.

Please visit  for specifics on the pipeline.

* All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

Position Overview

Tonix Pharmaceuticals is seeking a highly accomplished Senior Director of DMPK & Bioanalysis (BA) to provide strategic, scientific, and operational leadership for Bioanalysis (BA), drug metabolism, distribution, pharmacokinetics (PK), and pharmacodynamics (PD) activities across Tonix’s discovery and development portfolio.

This role will serve as the functional lead for BA and DMPK, partnering closely with discovery biology, medicinal chemistry, nonclinical development, CMC, regulatory, and clinical teams to advance small‑molecule and biologic programs from early Discovery through IND‑enabling and late‑stage development.

Key Responsibilities

Strategic & Functional Leadership

• Accountable for strategic direction of the DMPK and bioanalytical sciences in support of a dynamic and complex portfolio.
• Provide strategic, functional leadership and oversight of the nonclinical BA and DMPK function within the Nonclinical Development Department.
• Lead method development/validation for BA, PK/PD, Anti‑Drug Antibodies (ADA), and Immunogenicity assays.
• Manage outsourcing BA and DMPK assays to CROs for both nonclinical and clinical assets.
• Define and continuously evolve departmental strategies for in vitro and in vivo ADME, PK/PD, and Drug‑Drug Interaction (DDI) risk assessment.
• Ensure ongoing advancement of scientific capabilities, including training, methodologies, analytical approaches, and enabling technologies.
• Establish best practices and scientific standards to support rapid, data‑driven decision‑making in discovery and development.

Study Design, Execution & Interpretation

• Design, lead, and oversee nonclinical BA, DMPK, and PK/PD studies supporting lead optimization, candidate selection, IND‑enabling, and early clinical development.
• Lead the conduct, interpretation, and reporting of BA, in vitro and in vivo ADME, and PK/PD studies, ensuring scientific rigor and regulatory compliance.
• Work closely with Research and Nonclinical Development teams:
  • Define optimal target product profiles and candidate characteristics.
  • Develop fit‑for‑purpose testing strategies.
  • Identify and mitigate PK, ADME, and DDI liabilities.
• Collaborate with PK/PD modelers to establish exposure–response…