Senior Director, Clinical Pharmacology

🕒 March 27

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BBOT

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

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 multiple oncology programs, ensuring alignment with regulatory requirements and scientific standards. • Design and oversee clinical pharmacology studies to support multiple oncology program clinical development. • Collaborate with cross-functional teams, including clinical 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 dossier) and serve as subject matter expert in regulatory interactions with FDA and other global health authorities. • Stay abreast of industry trends and advancements in clinical pharmacology and oncology, contributing to the scientific community through presentations and publications.

🎯 Requirements

• Ph.D. or equivalent in pharmacokinetics (PK)/pharmacodynamics (PD), Pharmacology, Chemistry, or a related field. • Minimum of 10 years (SD) or 15 years (ED) of experience in clinical pharmacology, particularly with small molecule modality 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. • Quantitative pharmacology skillset preferred, e.g. PBPK, PK/PD modeling, population PK, and exposure-response analyses. • Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.

🏖️ Benefits

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