Merck

We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate 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.. Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.. Ph. D. with 1-3 years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.. Masters or PharmD with 3-5 years of experience, where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.. Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management, Software Development, Stakeholder Relationship Management

associate director

Job Description 
Role 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 Associate 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.
Associate Directors are emerging leaders in the field of quantitative drug development, with a developing understanding of the strategic elements of drug development and effective communication skills. As a subject matter expert, the Associate 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. 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 on drug development teams.
Primary Responsibilities: 
<ul>
<li>
Serving as an expert representative for QP2-IO on Oncology clinical development teams.
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Framing critical questions for optimizing model-based analyses on programs.
</li>
<li>
Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.
</li>
<li>
Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models.
</li>
<li>
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. 
</li>
</ul>
Minimum education required: 
<ul>
<li>
Ph.D. with 1-3 years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.
</li>
<li>
Masters or PharmD with 3-5 years of experience, where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.
</li>
</ul>
Required Experience: 
<ul>
<li>
Demonstrated impactful experience with applications of pharmacometrics methods.
</li>
<li>
Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
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<li>
Proficiency in R, NONMEM or other similar programing language.
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<li>
Professional working proficiency in written and verbal communication.
</li>
</ul>
"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 "#R277874". Please note that standard commute is (less than) <50 miles." 
#EBRG 
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Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) 
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Effective 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, generally Tuesday, Wednesday and either Monday or 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".
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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. 
<h3>Expected salary range</h3>
$149,400.00 - $235,100.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .
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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 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: 
Remote
Shift: 
1st - Day
Valid Driving License: 
No
Hazardous Material(s): 
N/A
Required Skills: 
Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management, Software Development, Stakeholder Relationship Management
Preferred Skills: 
Requisition ID: R277871 
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