About this opportunity
bbotx inc. lists this Director or Senior Director, Clinical Pharmacology opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
All Jobs > Director or Senior Director, Clinical Pharmacology
Director or Senior Director, Clinical Pharmacology
Fully Remote • Nationwide • Clinical Pharmacology
Full-time
Description
About BridgeBio 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 BBOTx.com.
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 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
Education and Qualifications – Senior Director, Clinical Pharmacology
Ph.D. or equivalent in pharmacokinetics (PK)/pharmacodynamics (PD), Pharmacology, Chemistry, or a related field
10–15 years of experience in clinical pharmacology, particularly with small molecule modalities within the oncology therapeutic area
Demonstrated ability to independently lead clinical pharmacology strategy across multiple concurrent programs, with a strong regulatory track record
Extensive experience developing and reviewing regulatory submissions and representing clinical pharmacology in health authority interactions
Deep understanding of oncology drug development processes and regulatory guidelines, with the ability to anticipate and proactively address regulatory questions
Advanced quantitative pharmacology skillset required, including PBPK, population PK, PK/PD modeling, and exposure–response analyses
Proven ability to influence cross-functional strategy and communicate complex scientific concepts to diverse audiences including senior leadership and health authorities
Excellent communication and interpersonal skills; experience mentoring junior scientists and contributing to team-building in a matrix environment
Prior experience in a lean or startup environment is highly desirable
Compensation
BBOT considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role.
Base compensation is part of a robust total rewards offering at BBOT. Additional total rewards elements include annual bonus, stock-based long-term incentives, medical, dental, and vision benefits, retirement, wellness stipend, and flexible time off.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.