Director, Clinical Pharmacology Lead

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. Ability to influence multidisciplinary teams, drive strategic decisions, and operate effectively within a matrix organization. Excellent written, verbal, presentation, communication, and interpersonal skills. Demonstrated ability to work independently, exercise sound scientific judgment, mentor others, and provide strategic leadership across complex development programs. Benefits Base salary range of $209,000–$287,750 , with final compensation determined by relevant skills, experience, location, and internal equity. Eligibility for short- and long-term incentives, including cash bonus and equity incentive opportunities. Medical, dental, vision, and life insurance. Fitness and wellness programs, including fitness reimbursement. Short- and long-term disability insurance. At least 15 days of paid vacation, plus additional year-end shutdown time from December 26–31. Up to 12 company-paid holidays plus 3 paid days for Personal Significance. 80 hours of paid sick time per calendar year. Paid maternity and parental leave. 401(k) participation with company matching contributions. Employee stock purchase plan. Tuition reimbursement of up to $10,000 per calendar year. Employee Resource Group participation and opportunities for professional growth and development. Remote, U.S.-based working arrangement.