Director, Clinical Pharmacology

Overview

Position Summary The Director, Clinical Pharmacology, plays a pivotal role in leading clinical pharmacology activities to support drug development programs. The incumbent will apply model-informed drug development (MIDD) approaches to optimize the benefit-risk profile of oncologic drugs, while increasing the probability of success and efficiency of drug development programs. This position also involves designing and executing the clinical pharmacology components of clinical studies, conducting and interpreting pharmacokinetic (PK), PK/pharmacodynamic (PD) and exposure/response (E/R) analyses, collaborating with interdisciplinary teams, and contributing to regulatory filings and interactions.

This is an onsite position in San Diego.

• Act as clinical pharmacology lead in study teams and provide clinical pharmacology expertise to study design, data analysis and interpretation, and oversee clinical pharmacology studies by working with CROs.
• Conduct non-compartmental analysis of human clinical PK data, and PK/PD analyses including population PK, PK/PD and Exposure/response modeling and simulation, and meta-analysis.
• Provide the clinical pharmacology components of Clinical Development Plans, IBs, and regulatory documents such as INDs, briefing documents, responses to regulatory queries, etc.
• Design, author and/or review clinical (pharmacology) study protocols, including PK/PD, drug-drug interaction (DDI), bioavailability, and first-in-human studies, and support the execution of clinical trials when applicable, conduct pharmacometrics analyses, and incorporate findings into study reports and regulatory documents as well as participate directly in regulatory interactions.
• Provide Clinical Pharmacology expertise to discovery teams during the pre-clinical stages of drug development and work with research colleagues to ensure quantitative mechanistic understanding of preclinical PK-PD data to inform human administration.
• Develop an MIDD strategy that integrates nonclinical data, quantitative understanding of the relationship among dose, PK, PD, efficacy and safety endpoints in the context of heterogeneous diseases (e.g., biomarkers), patient populations (e.g., intrinsic and extrinsic factors) and competitive landscape to make go/no go decisions, support dose and dosing regimen selection, and optimize preclinical and clinical study designs (sample size, duration, endpoints) throughout drug discovery and development.

• Ph.D. or Pharm
  
  D or equivalent in life sciences, pharmaceutical sciences or related field.
• 5 to 10 years of related experience.
• Strong hands-on experience with pharmacometrics software (e.g., NONMEM, Monolix, Phoenix Win Nonlin, R).
• Understanding of drug development in oncology or other therapeutic areas.
• Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies.
• Excellent interpersonal, leadership, communication and time-management skills are essential.

The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Blossom Hill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to Blossom Hills’ employees is strictly prohibited.

Unsolicited referrals and resumes sent to Blossom Hill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.