Senior Director, Clinical Pharmacology/Translational

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $165k - $242k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Provide scientific and strategic leadership for translational clinical pharmacology across a diverse pipeline from early development through late-stage and registrational programs • Develop and execute clinical pharmacology strategies addressing CNS exposure, dose optimization, and translational relevance • Lead collection and interpretation of in vitro, in vivo, literature, competitive-source, and clinical data to develop a translational knowledge base • Drive dose selection and optimization by integrating PK, PD, safety, efficacy, and CNS-specific biomarkers • Lead model-informed drug development, including population PK, PK/PD, and exposure–response analyses • Assess and guide strategies for CNS exposure, brain penetration, target engagement, and translational biomarkers • Lead clinical pharmacology strategy for CNS and neuroscience programs from first-in-human through registrational and post-marketing stages • Design, execute, and interpret clinical pharmacology studies, including FIH, multiple-ascending dose, DDI, biopharmaceutics, and patient studies • Serve as clinical pharmacology lead on program teams, clinical sub-teams, and trial working groups • Author and oversee clinical pharmacology sections of regulatory documents, including INDs, CTAs, IBs, and NDAs • Represent clinical pharmacology in interactions with FDA and other global health authorities • Partner with DMPK, Translational Sciences, Clinical Development, Biomarkers, Biostatistics, CMC, and Regulatory Affairs • Oversee CROs and external vendors conducting clinical pharmacology and modeling activities • Communicate and interpret clinical pharmacology results to internal stakeholders • Contribute to portfolio strategy, program prioritization, risk mitigation, and long-range clinical development planning for CNS assets • Serve as a subject-matter expert on clinical pharmacology • Mentor and develop clinical pharmacology talent • Ensure high-quality, submission-ready documentation aligned with global regulatory standards

🎯 Requirements

• PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline • 10+ years of experience in clinical pharmacology within biopharma, with demonstrated impact in translational science in drug development • Strong expertise in PK, PD, PK/PD integration, exposure–response analyses, and drug–drug interaction assessment • Extensive experience developing and executing clinical pharmacology strategies for early- through late-stage programs, including registrational support • Demonstrated experience applying quantitative clinical pharmacology and translational approaches, such as population PK and mechanistic PK/PD modeling, to inform CNS dose selection and optimization • Proficiency with clinical pharmacology tools and platforms such as NONMEM, R, Phoenix WinNonlin, SimCyp, or equivalent • Experience authoring and delivering clinical pharmacology components of regulatory submissions, including INDs, CTAs, and NDAs, and interacting with global health authorities • Strong understanding of translational PK, CNS exposure considerations, and biomarker integration in neuroscience drug development • Excellent communication, collaboration, and leadership skills with the ability to operate effectively in a fast-paced, matrixed environment

🏖️ Benefits

• Company bonus eligibility based partly on company and individual performance • Pension plan eligibility • Vacation benefits • Healthcare benefits eligibility • Flexible benefits • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities