Senior Director and head of DMPK & Bioanalytical
Tonix Pharmaceuticals, Frederick, Maryland, United States, 21701
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® SymTouch® (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 www.Tonixpharma.com 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 relationships, guide dose selection, and support translational strategies. Cross‑Functional Program Leadership 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> Prepare concise, decision‑enabling data summaries and presentations for project teams, governance committees, senior management, and external partners. > Regulatory & IND Support
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> 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. Operational Excellence & CRO Oversight 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. Necessary Skills and Abilities 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. Educational and Experience Requirements 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. Salary Range $200,000 - $300,000 USD Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Tonix provides a comprehensive compensation and benefits package which includes: 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 Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
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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® SymTouch® (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 www.Tonixpharma.com 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 relationships, guide dose selection, and support translational strategies. Cross‑Functional Program Leadership 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> Prepare concise, decision‑enabling data summaries and presentations for project teams, governance committees, senior management, and external partners. > Regulatory & IND Support
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> 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. Operational Excellence & CRO Oversight 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. Necessary Skills and Abilities 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. Educational and Experience Requirements 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. Salary Range $200,000 - $300,000 USD Recruitment & Staffing Agencies Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Tonix provides a comprehensive compensation and benefits package which includes: 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 Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
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