Director or Senior Director, Clinical Pharmacology

Location: Northern

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Director or Senior Director, Clinical Pharmacology

Director or Senior Director, Clinical Pharmacology
Fully Remote
• Nationwide
• Clinical Pharmacology

Full-time
Description About Bridge Bio Oncology Therapeutics

BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit
Who You Are

We are seeking a Director or Senior Director, Clinical Pharmacology to provide scientific and strategic leadership across BBOT’s oncology pipeline. Reporting to senior leadership, the Director/Senior Director will own the clinical pharmacology strategy for one or more programs, drive model-informed drug development approaches, plan and oversee clinical pharmacology clinical trials, and serve as a subject matter expert in regulatory interactions. The successful candidate will work closely with cross-functional teams including clinical operations, biostatistics, and regulatory affairs to advance BBOT’s small molecule oncology programs.

Level of appointment will be commensurate with experience.
Responsibilities
• 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 Education and Qualifications – Director, Clinical Pharmacology
• 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…