Senior Advisor, Clinical Pharmacology

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

📋 Description

• Deliver clinical pharmacology and PK/PD insights to project teams, aiding in decisions regarding dosage, patient demographics, and study design.

• Execute and analyze noncompartmental and population PK assessments for Phase 1–2 trials, encompassing FIH, SAD/MAD, DDI, food effect, organ impairment, and patient studies.

• Develop and utilize exposure–response and PK/PD analyses along with PBPK models to facilitate dose selection and assess drug–drug interaction risks.

• Combine nonclinical PK/PD, in vitro ADME, and biomarker data to enhance human PK and dose estimations, interspecies scaling, and first-in-human justifications.

• Compose PK/PD sections for clinical development plans, protocols, analysis strategies, investigator brochures, study reports, and regulatory submissions including IND, CTA, and NDA/MAA.

• Collaborate with DMPK, translational sciences, clinical development, bioanalysis, biostatistics, regulatory affairs, and project leadership.

• Oversee day-to-day scientific deliverables from CROs and vendors, and engage in peer reviews of analyses and reports.

• Communicate findings to internal stakeholders and contribute to external scientific publications and presentations.

• Report directly to the Executive Director of Clinical Pharmacology.

• Construct, assess, and elucidate quantitative models while progressively taking responsibility for clinical pharmacology deliverables within project teams.

⛳️ Requirements

• PhD or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmacokinetics, Pharmaceutical Sciences, or a related field, or a graduate degree in these areas with a robust demonstrated work history.

• A minimum of 3 years of industry experience in clinical pharmacology or pharmacometrics within biotech, pharmaceutical, or drug development sectors; relevant postdoctoral experience is also considered.

• Comprehensive understanding of PK/PD theory, ADME, DDI mechanisms including in vitro-to-clinical translation, and MIDD principles.

• Proficient in using NONMEM, Phoenix WinNonlin/NLME, Monolix, R, or similar software.

• Capability to select suitable analyses, troubleshoot modeling challenges, and clearly articulate a model's assumptions and limitations.

• Familiarity with FDA, EMA, and ICH guidelines pertinent to clinical pharmacology, including ICH M12 and ICH M15.

• Interest in translational medicine, particularly in areas of target engagement, biomarkers, and the transition from nonclinical to clinical settings.

• Ability to operate efficiently in cross-functional, matrixed environments.

• Outstanding communication and stakeholder management capabilities.

• Experience with PBPK platforms such as Simcyp, GastroPlus, or PK-Sim, or QSP modeling is advantageous.

🏝️ Benefits

• Company bonus based, in part, on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• Flexible spending accounts for healthcare and/or dependent day care.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and various employee clubs and activities.