Associate Director, Clinical Pharmacology - Oncology Biotech

SystImmune; Princeton (NJ); On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

SystImmune seeks a Senior Manager/Associate Director of Clinical Pharmacology to lead PK/PD and pharmacometrics strategies for ADC assets. You will collaborate with Clinical, Research, Regulatory, Biometrics, and others, managing pharmacology studies, data analyses, and regulatory filings.

The role requires expertise in dose optimization, DDI assessment, and quantitative analyses across all development phases, including regulatory interactions.

Qualifications

• Experience with first-in-human and proof-of-concept studies.
• Understanding of drug development including MIDD and the R&D process.
• ADC development experience is a plus.

Responsibilities

• Lead high-complexity oncology clinical pharmacology studies.
• Guide dose and schedule optimization; address DDI with cross-functional colleagues.
• Perform quantitative pharmacology analyses and interpret study results.
• Conduct pharmacometric analyses to support drug development.
• Lead preparation and review of clinical pharmacology sections for protocols, reports and regulatory filings.

Skills

PK/PD modeling

Exposure-Response

Quantitative pharmacology

Regulatory submissions

MIDD

Education

MS/PhD in pharmacology

Tools

NONMEM

R

Simcyp

WinNonlin

Job description

Weare seeking a high-quality Senior Manager/Associate Director of Clinical Pharmacology to lead the development and execution of clinical pharmacology strategies for ADC assets. The ideal candidate will provide expertise in pharmacokinetics, dose optimization, pharmacometrics, and drug interaction assessment, collaborate with cross-functional teams (Clinical, Research, Regulatory, Biometrics, etc.), and manage clinical pharmacology studies, data analysis, and regulatory filings.

Essential Duties and Responsibilities:

• Play a pivotal role in planning and conducting cutting-edge oncology clinical pharmacology studies that are of higher complexity both in scope and volume
• Guide dose and schedule determination, dose optimization, and drug-drug interaction issues, collaborating closely with cross functional colleagues
• Perform quantitative pharmacology analyses and contributes to the interpretation of study results through all phases of clinical development
• Perform pharmacometric analyses to support drug development and address scientific questions
• Take a lead role in preparing and meticulously reviewing clinical pharmacology sections of study protocols, reports, investigators' brochures and regulatory filings (IND’s, BLA’s, etc.), and responds to regulatory inquiries related to clinical pharmacology

Required Qualifications:

• Experience with a range of clinical studies including first-in-human, proof-of-concept and registrational studies
• Understanding of drug development, including model informed drug development (MIDD) and the overall pharmaceutical R&D process
• Advanced knowledge and understanding of pharmacokinetics (PK), pharmacodynamics (PD), PK/PD, Exposure-Response (ER), and Quantitative systems pharmacology
• Demonstration of strong quantitative skills, conceptual, technical and hands on development expertise with modelling and simulation activities (NCA, population modelling, exposure-response analyses etc)
• Familiar with analysis software (e.g., NONMEM, R, Simcyp, WinNonlin) along with PK modeling and computer skills in scientific graphing

Education And Experience:

• MS, PharmD, or PhD in biological or pharmaceutical sciences, with a focus on pharmacology and pharmacometrics
• Understanding of clinical pharmacology study design, data analysis, and regulatory requirements
• Minimum1 - 5 years of experience in clinical pharmacology and pharmacometrics, with hands-on experience in quantitative analysis
• Prior experience in the field of ADC development is a plus

The hiring pay range for this position is $150,000 - $200,000 per year based on skills, education, and experience relevant to the role.

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.