Director, Quantitative Pharmacology and Pharmacometrics, Immune/Oncology
Director, Quantitative Pharmacology and Pharmacometrics, Immune/Oncology
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 187000 - 294400
1 Vacancy
Job Description
Job Description
Role and Responsibilities:
We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics Immune/Oncology (QP2IO) team in the role of Director Quantitative Systems Pharmacology (QSP). QP2IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology mechanistic PKPD modeling and pharmacometrics of oncology drugs from postPCC 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 QP2IO Group will work closely with teams of highly collaborative crossfunctional 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 QP2IO 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 modelbased 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 exposureresponse 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 modelbased analyses on programs.
Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics (monoclonal antibodies antibody drug conjugates Tcell engagers bispecifics) in Oncology authoring regulatory documents (investigational new drugs/INDs clinical study reports (CSRs) clinical trial applications (CTDs)) and representing QP2IO 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 PKPD models and QSP models for decision making in early and/or latestage clinical development
Experience with mechanistic modeling for antibody drug conjugates (ADCs) and/ or Tcell 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 modelbased approaches.
Current Employees apply HERE
Current Contingent Workers apply HERE
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.
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 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 anothers thinking and approach problems collectively.
Learn more about your rights including under California Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 candidates relevant skills experience and education.
Expected US salary range:
$187000.00 $294400.00Available 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 here.
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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Business Intelligence (BI) Database Design Data Engineering Data Modeling Data Science Data Visualization Machine Learning Software Development Stakeholder Relationship Management Waterfall ModelPreferred Skills:
Job Posting End Date:
05/30/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
