Executive Director / VP, Clinical Pharmacology & Pharmacometrics (CPP)

Location: Boston/ Pennsylvania United States
Employment: Full-Time | Permanent
Level: Executive Director / Vice President
Therapeutic Area: Immunology / Inflammation / Immune-Mediated Diseases

Are you an experienced Clinical Pharmacology and Pharmacometrics leader with a strong background in quantitative drug development and Model-Informed Drug Development (MIDD)? This is an exciting opportunity to join an innovative biotechnology company harnessing AI to accelerate the development of breakthrough biologic therapies for difficult immune-mediated diseases and patients with significant unmet medical needs.

We are seeking a strategic, hands-on Executive Director / VP of Clinical Pharmacology & Pharmacometrics to build and lead the global CPP function, supporting programmes from preclinical development and candidate selection through First-in-Human (FIH), dose optimisation and clinical Proof-of-Concept (PoC), with a clear pathway towards registration.

The successful candidate will combine deep technical expertise in pharmacometrics and quantitative modelling with the ability to influence portfolio decisions, guide clinical development strategy and translate complex datasets into actionable recommendations. This is an opportunity to play a pivotal role as the company's first wave of therapeutic programmes advances towards clinical development.

Key Responsibilities:

• Develop global Clinical Pharmacology and Model-Informed Drug Development (MIDD) strategies, integrating nonclinical and clinical PK/PD, exposure-response, biomarkers, efficacy, safety and immunogenicity.

• Provide quantitative recommendations on FIH starting doses, dose escalation, dosing frequency, formulations, food-effect studies and special populations.

• Direct population PK, PK/PD, exposure-response, PBPK, translational modelling and clinical trial simulations to inform portfolio decisions.

• Translate nonclinical pharmacology, DMPK, toxicology, bioanalytical and biomarker data into human PK projections, therapeutic exposure targets and safety margins.

• Partner with CMC, Formulation and Clinical Operations to establish PK/PD and biomarker sampling strategies, formulation comparability and IND/CTA-enabling plans.

• Integrate emerging PK/PD, safety, efficacy and immunogenicity data to optimise dosing across biologics and oral therapeutics.

• Establish quantitative development strategies from clinical PoC through registration, including dose justification, special population labelling and post-approval commitments.

• Own integrated CPP plans, milestones and budgets, overseeing external pharmacometrics, bioanalytical and modelling vendors.

• Identify and mitigate quantitative and translational development risks, balancing development timelines with scientific rigour, safety and regulatory requirements.

• Serve as the primary CPP expert and representative in interactions with the FDA, EMA, NMPA, KOLs and internal governance boards.

• Support business development, licensing and due diligence activities through the evaluation of translational models, human PK projections and dose feasibility.

• Build a scalable CPP function, establishing quantitative workflows, model documentation, data standards and regulatory-compliant processes.

Candidate Requirements:

• PhD, PharmD, MD or equivalent in Clinical Pharmacology, Pharmacometrics, Pharmaceutical Sciences or a relevant quantitative discipline.

• 5–7+ years of biotech/pharmaceutical CPP or MIDD leadership experience, spanning candidate selection, FIH, dose optimisation, PoC and later-stage development.

• Deep hands-on expertise in population PK, PK/PD, exposure-response modelling, clinical trial simulation and reproducible programming workflows.

• Proven experience authoring Clinical Pharmacology submission sections and defending dose justification strategies with major health authorities, including the FDA, EMA and NMPA.

• Demonstrated ability to integrate cross-functional data across CMC, Safety and Biomarkers.

• Experience managing external modelling, pharmacometrics and bioanalytical vendors.

• Experience in immunology, inflammation or immune-mediated diseases, including dermatology, rheumatology or gastroenterology, is desirable.

• Experience supporting both biologics (antibodies, multispecifics, TMDD and immunogenicity) and oral therapeutic modalities (DDI, absorption and food effect) is highly desirable.

• Exposure to advanced quantitative approaches, including PBPK, QSP, disease-progression modelling and model-based meta-analysis.

• Multi-regional development experience across the US, China and Europe is advantageous.

• Strong scientific communication, strategic leadership and stakeholder management skills, with the ability to influence cross-functional teams and executive leadership.

What's on Offer?

• Executive Director or Vice President-level opportunity within an innovative, rapidly growing biotechnology company.

• Opportunity to build and lead the global Clinical Pharmacology and Pharmacometrics function.

• Significant influence over drug development strategy, dose optimisation and portfolio-level decisions.

• Exposure to cutting-edge AI-enabled biologics development and innovative therapeutic programmes.

• Opportunity to shape the transition of early-stage programmes into clinical development and through Proof-of-Concept.

• Direct involvement in global regulatory strategy, business development and external scientific partnerships.

• A collaborative, multidisciplinary and entrepreneurial environment with significant strategic responsibility and professional growth.

Location: Boston/ Pennsylvania United States

Employment: Full-time, permanent.