Director, Translational Pharmacokinetics - DMPK

Accountabilities: Pharmacokinetic Modeling and Simulation: Lead the design, development, validation, and refinement of PBPK models to characterize drug absorption, distribution, metabolism, and excretion (ADME). Develop and evolve PKPD models using nonclinical and clinical data to improve predictions of drug behavior and inform development strategies. First-in-Human Dose Projections: Generate scientifically robust first-in-human (FIH) dose projections for selected drug candidates advancing into clinical development. Support candidate selection and help establish appropriate initial dosing strategies based on available pharmacokinetic, pharmacodynamic, and translational evidence. Data Integration and Scientific Analysis: Integrate in vitro, nonclinical, and clinical pharmacokinetic and pharmacodynamic data into modeling frameworks. Critically evaluate experimental findings, assess model assumptions, and identify additional data or studies needed to strengthen model reliability. Drug-Drug Interaction Assessment: Conduct simulations to predict potential drug-drug interactions and evaluate how different physiological conditions may affect drug exposure. Use modeling insights to inform dosing recommendations, risk assessments, and development decisions. Regulatory Strategy and Documentation: Prepare and contribute to evidence-based modeling reports, simulations, and technical documentation supporting Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), Investigator's Brochures (IBs), briefing documents, regulatory responses, and health authority meetings. Participate in regulatory preparation and interactions as needed. Cross-Functional Collaboration: Partner with teams across drug metabolism and pharmacokinetics (DMPK), clinical pharmacology, translational sciences, chemistry, manufacturing and controls (CMC), clinical development, regulatory affairs, and project management. Provide scientific input into the design of in vitro and in vivo studies required to support model development and validation. Pipeline and Development Support: Contribute to candidate selection, development planning, and the transition of research programs into clinical development. Use modeling and simulation findings to guide program priorities and inform decisions throughout early-stage development. Scientific Leadership and Mentorship: Evaluate emerging scientific methods, industry developments, and competitive intelligence. Present program recommendations and modeling insights to senior leadership and governance committees, mentor junior scientists, and promote scientific rigor, innovation, and operational excellence across the portfolio. Project and Risk Management: Balance scientific priorities with development timelines, resource constraints, and program risks. Where relevant, coordinate external research partners and contract research organizations (CROs) to support outsourced modeling and development activities. Requirements Education: PhD, PharmD, or an equivalent advanced scientific degree in pharmacokinetics, pharmaceutical sciences, pharmacology, biomedical sciences, or a related discipline. Industry Experience: At least 12 years of industry experience in pharmacokinetic modeling and simulation, including PBPK and PKPD modeling and first-in-human dose projections. Modeling Expertise: Extensive hands-on experience developing, validating, and interpreting PBPK and PKPD models, with a strong understanding of ADME principles and the relationship between pharmacokinetics, pharmacodynamics, and clinical outcomes. Software Proficiency: Experience using pharmacokinetic modeling and simulation platforms such as Simcyp, GastroPlus, Phoenix WinNonlin, and NONMEM. Regulatory Experience: Demonstrated experience supporting IND-enabling programs and regulatory submissions, with the ability to translate complex scientific findings into clear, evidence-based documentation. Scientific Judgment: Strong analytical skills and the ability to critically evaluate experimental data, assess model limitations, validate assumptions, and develop reliable predictions that inform drug development decisions. Cross-Functional Leadership: Proven ability to work effectively across multidisciplinary teams in a collaborative, matrixed biotechnology or pharmaceutical environment, influencing decisions without relying solely on formal authority. Strategic and Communication Skills: Excellent scientific communication, presentation, and stakeholder management abilities, including the capacity to explain modeling results and recommendations to technical teams and senior leadership. Project and Risk Management: Strong organizational and project management capabilities, with the ability to balance scientific rigor, operational execution, competing priorities, and development timelines. Preferred Therapeutic Experience: Experience supporting central nervous system (CNS), neuroscience, rare disease, or sleep-wake disorder programs. Additional Preferred Qualifications: Familiarity with FDA, EMA, and ICH regulatory requirements; experience advancing drug candidates from selection through clinical development; and experience managing CRO networks or outsourced development activities. Leadership Competencies: Strategic thinking, sound scientific judgment, a hands-on and collaborative leadership style, adaptability, learning agility, and a demonstrated ability to mentor and develop scientific talent. Benefits Competitive Salary: Annual base salary ranging from $177,000 to $283,800 , depending on qualifications, experience, skills, and geographic location. Performance-Based Incentives: Eligibility for a company bonus based partly on organizational and individual performance. Comprehensive Healthcare: Medical, dental, vision, and prescription drug coverage for eligible employees. Retirement and Financial Benefits: Access to a company-sponsored 401(k) plan, pension benefits, and flexible spending options for eligible healthcare and dependent-care expenses. Paid Time Off: Vacation benefits and a range of leave options, subject to applicable company policies. Insurance Protection: Life insurance, death benefits, and additional financial protection options. Wellness Resources: Access to employee assistance programs, fitness benefits, and employee clubs and activities. Flexible Benefits: A range of benefits designed to support employees' health, financial well-being, and personal responsibilities. Remote Work Opportunity: The position is listed as remote in the United States, offering the potential to work outside a traditional office environment. Scientific and Professional Impact: The opportunity to influence early-stage drug development, contribute to regulatory and clinical decisions, and help advance innovative therapies for patients.