Director Quantitative Pharmacology and Pharmacometrics ImmuneOncology Remote
Director Quantitative Pharmacology and Pharmacometrics ImmuneOncology Remote
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$ 187000 - 294400
1 Vacancy
Job Description
Job Description
Job Description
Director QP2IO
We are seeking an experienced talented scientist to join theQuantitative Pharmacology and Pharmacometrics Immune/Oncology(QP2IO)team in the role of Director. QP2IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology 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 an expert representative for QP2 IO on Oncology development teams.
Framing critical questions and strategy for optimizing modelbased analyses on programs.
Developing and executing modelbased analyses including translational PK/PD approaches population pharmacokinetic models exposureresponse 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 /INDs clinical study reports (CSRs) clinical trial applications (CTDs) and representing QP2IO 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/interpretationand statistics.
An exemplary record of increasing responsibility independence and demonstrated impact in driving drug development decisions through application of modelbased approaches.
Proficiency in R NONMEMMATLAB 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. Please note that standard commute is (less than) <50 miles.
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.
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US and Puerto Rico Residents Only:
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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
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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:
Domestic/InternationalVISA Sponsorship:
YesTravel Requirements:
10Flexible Work Arrangements:
RemoteShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/ARequired 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:
04/30/2025*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
