Senior Director, Clinical Pharmacology – Pharmacometrics

This is a fully remote position, open to applicants in California.

📋 Description

• Take charge of the clinical pharmacology strategy and development plan for each program from IND to NDA/MAA.

• Spearhead first-in-human dose selection and escalation utilizing nonclinical PK/PD, toxicology, and translational data.

• Conduct and supervise translational and mechanistically based PK/PD modeling.

• Direct pharmacometrics strategies including population PK, PK/PD, exposure-response modeling and simulation, meta-analysis, and disease modeling.

• Assist with nonclinical PK/PD, ADME, and DMPK evaluations.

• Design and analyze clinical pharmacology studies, including renal/hepatic impairment, immunogenicity effects, and concentration-QTc strategy.

• Develop and implement pediatric dosing and extrapolation strategies for rare disease populations.

• Create and review clinical pharmacology content for regulatory documents, such as IND/CTA, Investigator’s Brochure, protocols, briefing packages, CSRs, and Module 2.7.2 summaries.

• Act as the representative for the functional area in interactions with the FDA, EMA, and other health authorities.

• Provide rationale for starting doses, design dose-escalation strategies, and integrate nonclinical and translational data from IND to NDA/BLA.

• Publish research papers and offer scientific leadership at external conferences and within the scientific community.

• Report directly to the Chief Development Officer.

⛳️ Requirements

• PhD in Pharmacometrics, Quantitative & Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline.

• Over 10 years of clinical pharmacology and/or pharmacometrics experience in the industry, demonstrating increasing leadership roles.

• Practical clinical pharmacology experience supporting programs from first-in-human through later-stage clinical development, preferably including novel modalities.

• Proven expertise in modeling and simulation, including tools like NONMEM, R, and Phoenix.

• Documented experience in authoring clinical pharmacology sections of regulatory submissions and engaging with health authorities.

• Background in a small or fast-paced biotech setting.

• Preferred experience in clinical pharmacology related to oligonucleotide therapeutics.

• Familiarity with intrathecal ASO and CNS/CSF pharmacokinetics.

• Experience in neurology, neuromuscular disorders, or rare diseases.

• Knowledge of pediatric development and extrapolation methods.

• Experience with registration (NDA/MAA) and involvement in late-stage regulatory meetings.

• Proficiency in PBPK, QSP, and disease progression modeling.

• Strong communication skills, with a collaborative approach and the ability to convey quantitative findings to clinical and executive audiences.

🏝️ Benefits

• Annual bonus.

• Equity.

• Comprehensive benefits package.

• Patient Days.

• Access to learning and development resources.

• Flexible PTO.

• Decentralized model with decision-making authority close to the science.

• Collaborative, fast-paced, data-driven environment.

• Opportunities for career ownership and development.