Associate Director – Clinical Pharmacology

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

📋 Description

• Develop and implement clinical pharmacology strategies for oncology small-molecule initiatives.

• Create pharmacokinetics/pharmacodynamics (PK/PD) studies to assist in dose selection and optimization.

• Utilize modeling and simulation techniques, such as physiologically-based pharmacokinetics (PBPK) and population pharmacokinetics (PK), to guide program decisions.

• Collaborate with Clinical Development, Drug Metabolism and Pharmacokinetics (DMPK), Biostatistics, Regulatory Affairs, and other cross-functional teams.

• Draft and evaluate protocols along with clinical pharmacology segments of regulatory submissions, including IND/IMPD, briefing documents, and Common Technical Document (CTD) modules.

• Prepare answers to inquiries from health authorities.

• Contribute to strategies for drug-drug interactions, organ impairment, and cardiac safety/QT assessments.

• Represent the Clinical Pharmacology function on oncology small-molecule program teams from late-stage discovery and IND-enabling activities through Phase 1 and beyond.

• Analyze, interpret, and present clinical pharmacokinetics, PK/PD, and exposure-response data.

• Design clinical pharmacology aspects of first-in-human studies, drug-drug interaction assessments, hepatic/renal impairment studies, food effect studies, cardiac safety evaluations, and combination therapy trials.

• Author and review Clinical Study Protocols, Investigator's Brochures (IBs), Standard Operating Procedures (SOPs), Statistical Analysis Plans, and Clinical Study Reports.

• Stay updated on pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics.

• Review and produce scientific publications, abstracts, and posters.

• Mentor junior scientists within the department.

⛳️ Requirements

• PhD or equivalent degree in Pharmacology, Biomedicine, Biochemistry, or a related scientific field.

• A minimum of 5 years of relevant experience within the pharmaceutical industry, contract research, or clinical research.

• Experience in the clinical development of oncology small-molecule therapeutics is highly preferred.

• Familiarity with dose-escalation and expansion trial designs, as well as combination therapy regimens, is highly desirable.

• Proficient in using Phoenix WinNonlin for non-compartmental analysis.

• Working knowledge of PBPK modeling and current drug-drug interaction regulatory frameworks, including ICH M12 and FDA guidance, is highly advantageous.

• Practical experience in clinical pharmacology with a focus on writing regulatory and scientific documents, including Clinical Study Protocols, SOPs, Statistical Analysis Plans, Clinical Study Reports, and regulatory submissions.

• Knowledge of PK bioanalytical methods development and validation is a plus.

• Ability to manage multiple projects, prioritize tasks effectively, meet deadlines, foresee potential issues, and communicate alternative solutions.

• Strong communication abilities and capacity to work collaboratively within a cross-functional team.

• Current authorization to work in the United States.

• Must indicate whether visa sponsorship will be needed now or in the future.

🏝️ Benefits

• Company-sponsored healthcare.

• Flexible spending accounts.

• Optional life insurance.

• 401K matching.

• Unlimited vacation policy.

• Onsite gym facilities.

• Dining options at the facility.

• Brand-new, state-of-the-art facility.

• Convenient access to excellent living and recreational areas.