Director/Senior Director, Clinical Pharmacology

The Role

We are seeking a Director or Senior Director of Clinical Pharmacology to lead clinical pharmacology strategy and execution across our autoimmune pipeline. This is a key high-impact, high-visibility role that will shape how our molecules are characterized, dosed, and differentiated in the clinic. You will work at the intersection of quantitative modeling, translational medicine, regulatory strategy, and clinical development - and will have the opportunity to build out the clinical pharmacology function as the company grows.

What You'll Do

• Lead clinical pharmacology strategy and implementation across one or more programs, from first-in-human through proof-of-concept and beyond
• Develop and execute multidisciplinary clinical pharmacology plans including characterization of PK, evaluation of PK/PD and exposure-response relationships, and dose optimization strategies
• Analyze data from ongoing and completed clinical trials to identify dose- and exposure-related trends and signals in safety, efficacy, and patient subgroups to support development decisions
• Contribute to the design of clinical studies to support evidence generation and development objectives
• Integrate quantitative modeling techniques (e.g. population PK, PK/PD, PBPK, QSP) throughout development to inform dose selection, trial design, and labeling as needed
• Oversee and manage CRO clinical pharmacology and modeling vendors and contract sciences, ensuring scientific rigor and timeline adherence
• Represent the Clinical Pharmacology function on project teams with membership from clinical, regulatory, translational, CMC, and others
• Author and review regulatory documents including IND/IMPD sections, clinical pharmacology summaries, briefing documents, and NDA/BLA components
• Represent the company in interactions with FDA, EMA, and other health authorities on clinical pharmacology matters
• Contribute to lifecycle management strategies and support business development due diligence as needed
• Stay current with evolving regulatory guidance and methodological advances relevant to clinical pharmacology, pharmacometrics, and immunology and inflammation clinical development
• Help build best-in-class Clinical Pharmacology and Pharmacometrics capabilities as the organization grows

What You Bring

• D. in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences, or a closely related discipline; PharmD considered with relevant industry experience
• 10+ years (Director) or 15+ year (Senior Director) of industry experience in clinical pharmacology, with direct experience leading Clinical Pharmacology strategy and execution for clinical-stage programs through IND and beyond
• Strong foundation in the principles of PK, PK/PD, clinical pharmacology, and quantitative modeling techniques, compartmental and noncompartmental analysis, and population modeling; working knowledge of R, NONMEM, Phoenix, or equivalent platforms
• Demonstrated experience authoring regulatory documents and interacting with health authorities
• Experience in immunology, inflammation, or autoimmune disease areas strongly preferred
• Track record of operating effectively in cross-functional teams in a lean, fast-moving biotech environment
• Strong scientific communication skills, both written and oral - ability to translate complex Clinical Pharmacology concepts for clinical, regulatory, and executive audiences with a demonstrated record of meaningful impact

Base compensation for this position ranges from $230,000 - 300,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time. In addition, this position is eligible for participation in Lakefront Biotherapeutics' performance bonus plan. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.