Vice President / Executive Director, Clinical Pharmacology - High-growth Biotech

About the Company

• Our client is an innovation-driven biotechnology company focused on advancing differentiated therapies in neuroscience, pain management, and other areas of significant unmet medical need.
• The organization is building a world-class R&D platform and seeks an experienced Clinical Pharmacology leader to drive data-driven development strategies from First-in-Human (FIH) studies through late-stage clinical development and global regulatory submissions.

About the Job

This is a strategic leadership role responsible for defining and executing clinical pharmacology strategies across the company’s pipeline. The successful candidate will serve as a key scientific leader, leveraging modeling and simulation approaches to optimize clinical development decisions, accelerate proof-of-concept validation, and support global regulatory interactions.

• Develop and lead integrated clinical pharmacology strategies across multiple development programs, ensuring alignment with overall clinical and regulatory objectives.
• Design and oversee Phase I–III clinical pharmacology programs, including First-in-Human studies, dose-escalation strategies, dose selection, exposure-response assessments, and dosing regimen optimization.
• Lead the design, execution, interpretation, and reporting of PK/PD studies to support clinical development and registration strategies.
• Establish quantitative pharmacology frameworks to characterize exposure-response relationships, inform benefit-risk assessments, and support proof-of-concept (PoC) decision-making.
• Apply advanced Modeling & Simulation (M&S) methodologies, including PBPK, PopPK, PK/PD, and exposure-response modeling, to optimize development plans and reduce clinical development risk.
• Lead clinical pharmacology contributions to regulatory submissions, including IND, NDA, and global registration packages.
• Support regulatory interactions with agencies such as the FDA and NMPA by preparing clinical pharmacology briefing materials, responses to regulatory questions, and participating in formal agency meetings.
• Develop and implement innovative biomarker strategies, particularly in neuroscience, CNS, and pain-related indications, to support translational medicine and early clinical decision-making.
• Provide scientific leadership in the interpretation of pharmacokinetic, pharmacodynamic, efficacy, and safety data throughout the product lifecycle.
• Collaborate closely with Clinical Development, Medical Affairs, Clinical Operations, Biostatistics, Regulatory Affairs, Translational Medicine, and Nonclinical Research teams to ensure integrated development strategies.
• Influence portfolio decisions by providing quantitative insights regarding dose selection, trial design, probability of success, and development risk.
• Build and lead a high-performing Clinical Pharmacology organization, including recruitment, mentoring, capability development, and succession planning.
• Establish and expand internal Modeling & Simulation platforms and best practices to enhance organizational scientific capabilities.
• Serve as a recognized technical expert and strategic advisor to executive leadership on clinical pharmacology and quantitative drug development.

Required Qualifications

• PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacometrics, or a related scientific discipline.
• Minimum 8 years of experience in Clinical Pharmacology, Pharmacometrics, PK/PD, or Quantitative Clinical Pharmacology within the biotechnology, pharmaceutical, or CRO industry.
• At least 3 years of leadership experience managing clinical pharmacology, pharmacometrics, or quantitative sciences teams.
• Prior experience as a Clinical Pharmacology Lead or Head of Clinical Pharmacology within an innovative drug development environment is highly desirable.
• Demonstrated experience leading clinical pharmacology strategies for at least two innovative drug programs from First-in-Human studies through Phase III clinical development.
• Proven success supporting IND and/or NDA submissions with FDA, NMPA, or other major regulatory agencies.
• Experience in neuroscience, CNS, pain management, or related therapeutic areas is strongly preferred.
• Deep expertise in PK/PD modeling, exposure-response analysis, and quantitative drug development methodologies.
• Advanced proficiency with industry-standard modeling tools such as NONMEM, Monolix, R, Phoenix NLME, Simcyp, GastroPlus, or equivalent platforms.
• Hands-on experience with PBPK, PopPK, PK/PD modeling, exposure-response analysis, model-informed drug development (MIDD), and simulation-based decision-making.
• Comprehensive understanding of contemporary drug development processes, translational medicine strategies, and regulatory expectations related to clinical pharmacology.
• Strong scientific publication, technical writing, and regulatory documentation skills.
• Excellent analytical thinking, problem-solving, and data interpretation capabilities.
• Proven ability to influence cross-functional teams and communicate complex scientific concepts to senior stakeholders and regulatory agencies.
• Fluent English communication skills, with the ability to independently prepare and review clinical protocols, reports, study documents, and regulatory submissions.

Why This Opportunity?

• Lead the clinical pharmacology strategy for a growing pipeline of innovative therapies and directly influence key development decisions from FIH through registration.
• Build and shape a Clinical Pharmacology and Modeling & Simulation function, creating long-term scientific capabilities within a high-growth biotech environment.
• Work at the forefront of quantitative drug development, applying advanced MIDD, PK/PD modeling, and biomarker strategies to accelerate innovation.
• Partner closely with executive leadership, regulatory authorities, and leading scientific experts to drive global development programs.
• Make a meaningful impact on the development of novel therapies addressing significant unmet needs in neuroscience, pain, and other serious diseases.