Director, Clinical Pharmacology

🕒 July 3

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BBOT

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

BBOT is a biotechnology company developing targeted therapies for cancers driven by RAS signaling and PI3Kα. The company focuses on rational drug design to inhibit the active ON state of RAS and to selectively block RAS-driven PI3K activation, aiming at multiple KRAS mutants and novel approaches to maximize target inhibition. BBOT translates decades of RAS biology research into therapeutic candidates intended to improve outcomes for patients with RAS- and PI3Kα-driven tumors.

📋 Description

• Lead the clinical pharmacology strategy for one or more oncology programs, ensuring alignment with regulatory requirements and scientific standards • Design and oversee clinical pharmacology studies to support assigned oncology programs’ clinical development plans • Collaborate with cross-functional teams, including clinical development and operations, biostatistics, and regulatory affairs, to drive the advancement of drug development programs • Drive application of model-informed drug development (MIDD) approaches, including population PK/PD and exposure–response analyses • Author relevant sections/modules of regulatory documents (including INDs, IBs, CTAs, IMPDs, NDAs, briefing packages, or other regulatory dossiers) and serve as subject matter expert in regulatory interactions with FDA and other global health authorities • Interpret and communicate clinical pharmacology data and results to internal teams, health authorities, and external stakeholders • Partner with biostatistics and data management to establish analysis datasets, statistical analysis plans, and reporting standards for PK/PD endpoints • Contribute to dose selection and dosing regimen optimization across programs, leveraging exposure–response relationships and emerging clinical data • Provide clinical pharmacology input into study protocols, informed consent forms, and clinical study reports • Stay abreast of industry trends and advancements in clinical pharmacology and oncology, contributing to the scientific community through presentations and publications • Participate in cross-functional team meetings, providing clinical pharmacology insights and updates to internal stakeholders

🎯 Requirements

• Ph.D. or equivalent in pharmacokinetics (PK)/pharmacodynamics (PD), Pharmacology, Chemistry, or a related field • Minimum 8 years of experience in clinical pharmacology, particularly with small molecule modalities within the oncology therapeutic area • Proven track record of successfully managing clinical pharmacology studies and developing regulatory submissions • Strong understanding of oncology drug development processes and regulatory guidelines, including FDA and global health authority requirements • Quantitative pharmacology skillset preferred, e.g., PBPK, PK/PD modeling, population PK, and exposure–response analyses • Experience authoring clinical pharmacology sections of regulatory dossiers (INDs, NDAs, CTAs, briefing packages) • Excellent communication and interpersonal skills, with the ability to work collaboratively in a cross-functional team environment • Prior experience in a lean or startup environment is highly desirable.

🏖️ Benefits

• annual bonus • stock-based long-term incentives • medical, dental, and vision benefits • retirement • wellness stipend • flexible time off