Director Clinical Pharmacology (remote)

Haybury; Connecticut; On-site; USD 180,000 - 240,000; Full time

Job summary

Haybury, partners with a leading global biopharmaceutical company, seeks a Director-level Clinical Pharmacology Lead to own strategy across assets and development programs. You will integrate Clin Pharm, Pharmacometrics, and Non-clinical safety while guiding dose selection and modelling-based decisions.

You will mentor colleagues and influence milestones from early development through registration and launch, collaborating with Regulatory, Safety, Translational Medicine, and Commercial teams.

Qualifications

• PhD/PharmD/MD or equivalent advanced scientific qualification.
• Experience in Clinical Pharmacology beyond trial level.
• Strong PK/PD and regulatory submission experience.
• Familiarity with modelling & simulation including pharmacometrics.
• Experience in complex matrix organisations and stakeholder management.

Responsibilities

• Own and develop the Clinical Pharmacology strategy across multiple assets.
• Provide scientific leadership in PK/PD, DDI, formulation strategy and dose optimisation.
• Represent Clin Pharm, Pharmacometrics and Non-clinical safety on global project teams.
• Present scientific recommendations to project and governance teams.
• Lead Clinical Pharmacology input through milestones from early development to launch.
• Support regulatory strategy and global submissions.
• Collaborate with cross-functional partners in Clinical Development, Biostatistics, Regulatory Affairs, Safety, Translational Medicine, and Commercial.
• Mentor colleagues and advance Clinical Pharmacology capabilities.

Education

PhD, PharmD, MD or equivalent

Experience in Clinical Pharmacology beyond trial level

Tools

NONMEM

Job description

Haybury is partnering with a leading global research-driven biopharmaceutical company to identify a Director level Clinical Pharmacology Lead.

You will take asset-level ownership of Clinical Pharmacology strategy, working across multiple development programmes and helping teams make critical decisions around dose selection, PK/PD, exposure-response, drug-drug interactions and overall clinical development strategy for innovative therapies spanning both established and emerging modalities.

You'll also step beyond traditional Clinical Pharmacology and take on a broader leadership role, acting as an integrator across scientific disciplines and representing Clinical Pharmacology, Pharmacometrics and Non Clinical safety within global project teams and governance forums.

Working within a highly respected Clinical Pharmacology function, you will help shape development strategies from early clinical development through registration and launch, influencing critical decisions that ultimately impact patients worldwide.

Key Responsibilities

• Own and develop the Clinical Pharmacology strategy across multiple assets, from small molecules to biologics, oligonucleotides and gene therapies.
• Provide scientific leadership in areas including PK/PD, drug-drug interactions, formulation strategy, dose optimisation, immunogenicity assessments, renal/hepatic impairment, QT evaluation, and Model-Informed Drug Development.
• Serve as the Clinical Pharmacology representative on global project teams, including representing Clin Pharm, Pharmacometrics and Non-clinical safety in highly visible governance forums
• Present scientific recommendations to project and governance teams, challenging and influencing direction where the data supports it
• Lead Clinical Pharmacology input and influence key development milestones from early development through registration and commercial launch.
• Support regulatory strategy, health authority interactions and global submissions
• Collaborate closely with cross-functional partners across Clinical Development, Biostatistics, Pharmacometrics, Regulatory Affairs, Safety, Translational Medicine, and Commercial functions.
• Evaluate and implement innovative clinical pharmacology approaches and emerging technologies.
• Mentor colleagues and contribute to the ongoing advancement of Clinical Pharmacology capabilities.

What We're Looking For

• PhD, PharmD, MD, or equivalent advanced scientific qualification.
• Experience within Clinical Pharmacology in the pharmaceutical, biotechnology, regulatory, or related research environments, above the trial level.
• Strong expertise in PK, PK/PD, Clinical Pharmacology, Biopharmaceutics, and clinical drug development.
• Experience contributing to clinical development strategies across multiple stages of development.
• Understanding of modelling and simulation approaches, including exposure to pharmacometric methodologies.
• Experience working within complex matrix organisations.
• Excellent communication and stakeholder management skills.
• Experience supporting both small molecule and biologic development programmes.
• Knowledge of regulatory Clinical Pharmacology requirements and interactions.
• Experience with Model-Informed Drug Development.
• Familiarity with NONMEM and pharmacometric modelling tools.
• Experience supporting global regulatory submissions.

Why This Opportunity?

This organisation has built a reputation for scientific excellence, long-term investment in innovation, and a collaborative culture where employees are empowered to make a meaningful impact. You'll join a company that combines the resources and reach of a global leader with a strong commitment to research, personal development, and patient-focused innovation.

The successful candidate will have the opportunity to influence programmes of significant scientific and commercial importance while collaborating with internationally recognised experts across discovery, development, and regulatory functions.