Associate Director – Clinical Pharmacology

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🏄 California – Remote

🏄 California – Remote

💵 $164k - $245k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 1%

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Iambic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 Series B on 2024-04

Healthcare • Consulting • Manufacturing

Iambic Therapeutics is a pioneering biotechnology company that leverages advanced AI algorithms for drug discovery. Their innovative, high-throughput experimental platform aims to address unmet patient needs by optimizing molecules for various therapeutic targets. The company's AI-driven approach allows it to rapidly explore chemical spaces, revealing novel drug mechanisms and delivering high-quality leads at an accelerated pace compared to traditional methods.

📋 Description

• Design and execute clinical pharmacology strategy for oncology small-molecule programs • Design PK/PD studies and support dose selection and optimization • Apply modeling and simulation approaches, including PBPK and population PK, to inform program decisions • Partner with Clinical Development, DMPK, Biostatistics, Regulatory Affairs, and other multidisciplinary teams • Author and review protocols and clinical pharmacology sections of regulatory submissions, including IND/IMPD, briefing documents, and CTD modules • Prepare responses to health authority queries • Contribute to drug-drug interaction, organ impairment, and cardiac safety/QT assessment strategies • Represent the Clinical Pharmacology line function on oncology small-molecule program teams from late-stage discovery and IND-enabling activities through Phase 1 and beyond • Analyze, interpret, and report clinical PK, PK/PD, and exposure-response data • Design clinical pharmacology components of first-in-human, drug-drug interaction, hepatic/renal impairment, food-effect, cardiac safety, and combination-therapy studies • Write and review Clinical Study Protocols, IBs, SOPs, Statistical Analysis Plans, and Clinical Study Reports • Maintain knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics • Review and author scientific publications, abstracts, and posters • Mentor junior scientists within the function

🎯 Requirements

• PhD or equivalent in Pharmacology, Biomedicine, Biochemistry, or related scientific discipline • Minimum 5 years of relevant experience within pharmaceutical industry, contract research, or clinical research • Experience with clinical development of oncology small-molecule therapeutics is highly desirable • Familiarity with dose-escalation/expansion trial designs and combination-therapy regimens is highly desirable • Proficiency using Phoenix WinNonlin for non-compartmental analysis • Working knowledge of PBPK modeling and current DDI regulatory frameworks, including ICH M12 and FDA guidance, is highly desirable • Hands-on clinical pharmacology experience writing regulatory and scientific documentation, including Clinical Study Protocols, SOPs, Statistical Analysis Plans, Clinical Study Reports, and regulatory documents • Familiarity with PK bioanalytical methods development and validation is an asset • Ability to manage multiple projects, prioritize work effectively, meet deadlines, anticipate potential problems, and communicate alternatives • Strong communication skills and ability to work collaboratively on a cross-functional team • Current authorization to work in the United States • Must answer whether visa sponsorship will be required now or in the future

🏖️ Benefits

• Company-paid healthcare • Flexible spending accounts • Voluntary life insurance • 401K matching • Uncapped vacation • Onsite gym • Dining at the facility • Brand-new state-of-the-art facility • Easy access to great places to live and play