Director, Quantitative Pharmacology and Pharmacometrics – Oncology
Rahway, New Jersey, United States · Hybrid
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Senior+Visa sponsorship
Job Description We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Director. QP2-IO team is part of the Global Clinic…
Skills: Clinical Pharmacology, Pharmacometrics, Oncology, Drug Development, Data Modeling
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Director, Quantitative Pharmacology and Pharmacometrics – Oncology
The Director will serve as a subject matter expert for quantitative pharmacology and pharmacometrics on oncology development teams. They are responsible for developing model-based analysis strategies, authoring regulatory documents, and mentoring junior staff.
Requirements
Candidates must hold a Ph.D. with at least seven years of pharmaceutical drug development experience or a Master's/PharmD with nine years of experience. Proficiency in modeling software such as R, NONMEM, or MATLAB and experience with global regulatory submissions are required.
Full job description
Job Description
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. A
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.
The remote position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable, the position will be hybrid. Please note that standard commute is (less than) <50 miles."
#QP2
#EligibleforERP
Required Skills:
Clinical Pharmacology, Communication, Data Modeling, Data Visualization, Drug Development, Modeling Software, Pharmacology, Pharmacometrics, Program Leadership, Stakeholder Relationship Management
Preferred Skills:
Antibody Drug Conjugates (ADC), Biologics, Oncology, Small Molecule Drugs, T Cells
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.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
08/15/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
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