Tonix Pharmaceuticals · 10 hours ago
Senior Director and head of DMPK & Bioanalytical
Frederick, MD
Full-time
Onsite
Director/Executive
$200K/yr - $300K/yr
10+ years expTonix Pharmaceuticals is a fully integrated biotechnology company focused on developing therapeutics to treat and prevent human disease. They are seeking a Senior Director of DMPK & Bioanalysis to provide strategic leadership for bioanalysis and drug metabolism activities across their portfolio, collaborating with various teams to advance programs from discovery through development.
BiopharmaBiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
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
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
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
Company
Tonix Pharmaceuticals
Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP).
51-200 employees
H1B Sponsorship
Tonix Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$336.74MKey Investors
Point72Medical CBRN Defense ConsortiumTechnology Partners
2025-12-29Post Ipo Equity· $20M
2025-03-10Grant
2024-06-12Post Ipo Equity· $4M
Leadership Team
Seth Lederman
CEO
Zeil Rosenberg
Executive Vice President, Medical
Recent News
2025-12-29
2025-12-29
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