Director, Quantitative Pharmacology and Pharmacometrics – Oncology (Remote)

Job title: Director, Quantitative Pharmacology and Pharmacometrics – Oncology (Remote) in Rahway, NJ at MSD Company: MSD Job description: Job DescriptionRole and Responsibilities:We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Director, Quantitative Systems Pharmacology (QSP). QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology, mechanistic PK-PD modeling 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 a QSP expert for QP2 -IO for developing and executing model-based analyses including QSP models and mechanistic PK/PD models into programs thereby strengthening our quantitative capabilities on a continuous basis in decision making and driving pipeline impact.
• Assisting asset development teams in bringing forward combination drug approaches by leveraging QSP models to design and prioritize combination clinical trials
• Broad understanding of population pharmacokinetic models and exposure-response models for application in clinical development
• Work in close collaboration with biologists, clinicians, clinical pharmacologists, pharmacometricians and other line functions to improve our understanding of disease mechanisms and modalities
• Framing critical questions and strategy for optimizing model-based analyses on programs.
• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics (monoclonal antibodies, antibody drug conjugates, T-cell engagers, bispecifics) in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.

Minimum education required:

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

• Experience in developing mechanistic PK-PD models and QSP models for decision making in early and/or late-stage clinical development
• Experience with mechanistic modeling for antibody drug conjugates (ADCs) and/ or T-cell engagers will be preferred
• Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
• Experience with modeling and simulation packages or programming languages (e.g., MATLAB, R, SimBiology, C/C++)
• Experience working with external QSP vendors
• Familiarity with R, NONMEM, WINNONLIN or other similar programing language
• Professional working proficiency in written and verbal communication.
• Experience in IND, NDA and other submissions to global regulatory agencies.
• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches.

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 "#R345560”. Please note that standard commute is (less than) 50 miles."#EligibleforERP#QP2Current Employees applyCurrent Contingent Workers applyUS 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 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.U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.Expected US salary range: $187,000.00 - $294,400.00Available 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. A summary of benefits is listed .San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation: DomesticVISA Sponsorship: YesTravel Requirements: 25%Flexible Work Arrangements: RemoteShift: Not IndicatedValid Driving License: NoHazardous Material(s): n/aRequired Skills: Antibody Drug Conjugates (ADC), Clinical Pharmacology, Data Modeling, Data Modeling Software, Data Modeling Tools, Data Visualization, Drug Development, Pharmacology Research, Pharmacometrics, Regulatory DocumentsPreferred Skills: C (Programming Language), Clinical Trials, MathWorks SimBiology, MATLAB, Nonlinear Mixed Effects Modeling (NONMEM), NONMEM, Oncology, Pharmaceutical Development, PKPD Modeling, Programming Languages, Regulatory Submissions, R Programming, T CellsJob Posting End Date: 06/11/2025*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. Expected salary: Location: Rahway, NJ Apply for the job now! Apply for this job