Senior Director and head of DMPK & Bioanalytical

Tonix Pharmaceuticals • Frederick, MD

7d • $200,000 - $300,000

About The Position

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.

Requirements

• Deep expertise in drug ADME, and PK/P
• Strong understanding of small and large molecules drug discovery and development workflows.
• Hands-on experience designing, troubleshooting, and interpreting in vitro and in vivo BA and DMPK studies and assays.
• Familiarity with regulatory expectations for nonclinical and clinical BA and DMPK activities.
• Proven experience managing outsourced BA and DMPK program
• Strong scientific writing and presentation skills
• Demonstrated ability to operate effectively in a fast-paced, matrixed environment.
• High attention to detail, quality, and scientific integrity.
• Collaborative, forward-thinking leader capable of managing multiple programs simultaneously.
• Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemistry, or related discipline with 10+ years of relevant industry experience; or
• M.S./B.S. with 15+ years of relevant experience
• 10+ years of experience leading and representing DMPK/PK functions in discovery and early development programs.

Responsibilities

• 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 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.
• 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 relationships, guide dose selection, and support translational strategies.
• Serve as the BA and DMPK representative on discovery- and development-stage program teams, contributing at both strategic and technical levels.
• Coordinate closely with medicinal chemistry, biology, toxicology, formulation, and CMC teams to ensure integrated development strategies.
• Prepare concise, decision-enabling data summaries and presentations for project teams, governance committees, senior management, and external partner.
• Oversee the authorship, review, and scientific integrity of BA and DMPK sections for regulatory submissions, including INDs, NDAs, BLAs, Investigator Brochures, briefing packages, and regulatory responses.
• Support toxicology species selection and definition of toxicokinetic strategies aligned with FDA and ICH guidance.
• Enable human dose projections using allometric scaling, PK/PD modeling, and translational approaches.
• Provide operational oversight for internal and outsourced BA and DMPK studies and assays, ensuring data quality, regulatory compliance, and timely delivery.
• Select, qualify, and manage CROs and external vendors, including study design, execution, data review, and issue resolution.
• Develop, implement, and maintain SOPs governing BA and DMPK activities.
• Perform additional duties as assigned in support of departmental and organizational goals.

Benefits

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
• Pet Insurance
• Retirement Savings 401k with company match and annual discretionary stock options
• Generous Paid Time Off, Sick Time, & Paid Holidays
• Career Development and Training

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 51-100 employees