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

MSD; Rahway (NJ); Remote; USD 187,000 - 295,000; Full time

Job summary

An established industry player is seeking a talented Director for their Quantitative Pharmacology and Pharmacometrics team. This role involves leading innovative drug development strategies, optimizing model-based analyses, and collaborating with cross-functional teams to drive impactful decisions. The ideal candidate will possess a Ph.D. and extensive experience in pharmacometrics, with a proven track record in regulatory submissions and drug development. Join a dynamic environment where your expertise will shape the future of oncology treatments and contribute to groundbreaking advancements in healthcare.

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 required.
• Experience with IND, NDA submissions and pharmacometrics methods.

Responsibilities

• Lead quantitative analyses for oncology drug development.
• Collaborate with teams to optimize model-based strategies.

Skills

Pharmacokinetics/Pharmacodynamics (PKPD)

Pharmacometrics

Mathematics

Statistics/Biostatistics

Experimental Design

Critical Data Analysis

Modeling Software Proficiency (R, NONMEM, MATLAB, Monolix)

Education

Ph.D. in relevant 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 the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Director. The 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 the 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.

This (remote) position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable, please see requisition "#R332890”.

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.

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.

Employee Status: Regular

Relocation: Domestic/International

VISA Sponsorship: Yes

Travel Requirements: 10%

Flexible Work Arrangements: Remote