Director, Clinical Pharmacology Lead

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Clinical Pharmacology Lead based in the United States. This is a senior Clinical Pharmacology leadership role supporting late-stage development and registration activities across a transplant-focused portfolio. You will own Clinical Pharmacology strategy and execution, with significant influence over dose selection, benefit-risk assessment, regulatory submissions, and lifecycle planning. The role offers the opportunity to lead critical contributions to BLA and other major regulatory filings and engage directly with health authorities. You will operate at the intersection of Clinical Pharmacology, Pharmacometrics, Clinical Development, Regulatory, Biostatistics, and Biomarkers. The position requires scientific depth, regulatory expertise, and the ability to make strategic decisions within a complex matrix environment. You will also mentor colleagues and help advance Clinical Pharmacology capabilities across broader development programs. This is an opportunity to make a meaningful scientific and strategic impact on programs designed to address significant patient needs. Accountabilities - Represent Clinical Pharmacology on program and study teams and governance forums, influencing development strategy and key program decisions. - Develop and execute integrated Clinical Pharmacology strategies supporting dose selection and justification, benefit-risk assessment, regulatory approval, and lifecycle management. - Lead Clinical Pharmacology contributions to major regulatory submissions, including BLAs, supplemental filings, briefing packages, information requests, and regulatory responses. - Represent Clinical Pharmacology in health authority interactions and provide strategic leadership during regulatory meetings and review processes.

- Drive filing-readiness activities, proactively identify regulatory risks, and develop strategies to address potential challenges. - Lead and oversee Clinical Pharmacology analyses, including exposure-response assessments, population PK analyses, intrinsic and extrinsic factor evaluations, immunogenicity impact assessments, and Model-Informed Drug Development approaches. - Partner closely with Pharmacometrics and other quantitative disciplines to ensure analyses are scientifically rigorous and aligned with regulatory and development objectives. - Provide technical mentorship and scientific leadership within Clinical Pharmacology while contributing to the advancement of organizational capabilities. - Maintain current expertise in Clinical Pharmacology science, regulatory expectations, and development precedents relevant to transplant and immunology programs. Requirements - PhD, PharmD, MD, MD/PhD, or equivalent advanced degree in Pharmacology, Pharmacokinetics, Pharmaceutics, Clinical Pharmacology, or a related scientific discipline. - At least 8 years of relevant industry experience, including substantial experience in late-stage drug development, regulatory submissions, and health authority interactions. - Demonstrated experience serving as a Clinical Pharmacology Lead with accountability for development strategy and execution. - Proven experience authoring and defending Clinical Pharmacology sections of BLAs, NDAs, supplemental applications, or comparable regulatory submissions. - Hands-on experience supporting registration-enabling programs and leading Clinical Pharmacology interactions with regulatory agencies. - Strong expertise in dose justification, exposure-response analysis, immunogenicity assessment, and Model-Informed Drug Development methodologies. - Strong understanding of Clinical Pharmacology regulatory guidance and expectations applicable to biologic products. - Experience in transplant, nephrology, immunology, or a closely related therapeutic area is highly relevant.