Director or Senior Director, Clinical Pharmacology

All Jobs  >  Director or Senior Director, Clinical Pharmacology Apply Director or Senior Director, Clinical Pharmacology Fully Remote • Nationwide • Clinical Pharmacology Apply Job Type Full-time Description   About BridgeBio Oncology TherapeuticsBBOT 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 BBOTx.com.Who You AreWe 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.ResponsibilitiesLead the clinical pharmacology strategy for one or more oncology programs, ensuring alignment with regulatory requirements and scientific standardsDesign and oversee clinical pharmacology studies to support assigned oncology programs’ clinical development plansCollaborate with cross-functional teams, including clinical development and operations, biostatistics, and regulatory affairs, to drive the advancement of drug development programsDrive application of model-informed drug development (MIDD) approaches, including population PK/PD and exposure–response analysesAuthor 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 authoritiesInterpret and communicate clinical pharmacology data and results to internal teams, health authorities, and external stakeholdersPartner with biostatistics and data management to establish analysis datasets, statistical analysis plans, and reporting standards for PK/PD endpointsContribute to dose selection and dosing regimen optimization across programs, leveraging exposure–response relationships and emerging clinical dataProvide clinical pharmacology input into study protocols, informed consent forms, and clinical study reportsStay abreast of industry trends and advancements in clinical pharmacology and oncology, contributing to the scientific community through presentations and publicationsParticipate 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 fieldMinimum 8 years of experience in clinical pharmacology, particularly with small molecule modalities within the oncology therapeutic areaProven track record of successfully managing clinical pharmacology studies and developing regulatory submissionsStrong understanding of oncology drug development processes and regulatory guidelines, including FDA and global health authority requirementsQuantitative pharmacology skillset preferred, e.g., PBPK, PK/PD modeling, population PK, and exposure–response analysesExperience 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 environmentPrior experience in a lean or startup...