Director, Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (Remote)

Hispanic Alliance for Career Enhancement; Rahway (NJ); Remote; USD 187,000 - 295,000; Full time

Job summary

An established industry player is seeking a Director for their Quantitative Pharmacology and Pharmacometrics team focused on oncology drug development. This role involves leading model-based analyses, collaborating with cross-functional teams, and ensuring compliance with global regulatory standards. The ideal candidate will possess a Ph.D. with extensive experience in pharmacometrics and a strong record of driving drug development decisions. Join a dynamic team that values innovation and collaboration, and contribute to the development of novel therapies that can impact patient lives. This position offers flexibility and a competitive salary package.

Benefits

Bonus eligibility

Health care benefits

Retirement benefits

Paid holidays

Vacation days

Sick days

Long term incentive

Qualifications

• Ph.D. with 7+ years in pharmaceutical drug development or Masters/PharmD with 9+ years.
• Expertise in pharmacometrics, regulatory submissions, and model-based analyses.

Responsibilities

• Lead model-based analyses for oncology drug development.
• Mentor junior staff and ensure regulatory compliance.

Skills

Pharmacometric methods

Experimental design

Mathematical problem solving

Data analysis and interpretation

Statistics

Model-based approaches

Written communication

Verbal communication

Education

Ph.D. in related field

Masters or PharmD

Tools

R

NONMEM

MATLAB

Monolix

Job description

Job Description

Director QP2-IO

We are seeking an experienced talented scientist to join theQuantitative Pharmacology and Pharmacometrics –Immune/Oncology(QP2-IO)team in the role of Director. QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. Directors demonstrate outstanding leadership and communication skills. They collaborate within QP2-IO and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams.

Primary Responsibilities:

• Serving as an expert representative for QP2-IO on Oncology development teams.

• Framing critical questions and strategy for optimizing model-based analyses on programs.

• Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, and comparator modeling.

• Strategizing and executing modeling of tumor size and survival.

• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs), and representing QP2-IO at regulatory meetings.

• Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities.

Minimum education required:

• Ph.D. with at least seven years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.

• Masters or PharmD, with at least nine years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.

Required Experience:

• Demonstrated impact with applications of pharmacometrics methods.

• Experience in IND, NDA and other submissions to global regulatory agencies.

• Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.

• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches.

• Proficiency in R, NONMEM, MATLAB, Monolix or other modeling software.

• Professional working proficiency in written and verbal communication.

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Expected US salary range:

$187,000.00 - $294,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.