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1+ months

Remote Associate Director Pharmacometrics

Kelly Services
South Plainfield, NJ 07080 Work Remotely
**Kelly Services is seeking an Associate Director (title may vary depending on experience) for a REMOTE opportunity.**


The Associate Director, Pharmacometrics is responsible for the development of pharmacometrics through population PK, PK/PD, exposure-response analysis, and the development and application of other models as appropriate.


The Associate Director, Pharmacometrics is specifically responsible for performing modeling and simulations, PK & PK/PD assessments in patients, interpreting data and providing timely pharmacometrics support to clinical development and regulatory registration.


The incumbent works cross-functionally with internal departments and external resources, including but not limited to, clinical, biostatistics, regulatory, medical writing, and discovery research functions, as well as external Contract Research Organizations (CROs).


The Associate Director, Pharmacometrics supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.


**Job Description:**


_Primary duties/responsibilities:_


+ Contributes to pharmacometrics strategies in support of drug development, which align with team goals and meet regulatory requirements (IND and NDA etc.).

+ As assigned, works with external CRO/consultants on outsourced modeling projects and addresses regulatory queries related to pharmacometrics.

+ Performs hands on modeling to support drug development, preclinical PK/PD model and exploratory analysis.

+ Represents clinical pharmacology & DMPK on multidisciplinary projects and provides scientific leadership and strategic direction to clinical programs.

+ Develops and writes relevant documents, specifically clinical pharmacology sections.

+ Collaborates closely with the functional groups within clinical pharmacology & DMPK and other stakeholders.

+ Effectively communicates pharmacometrics data and the relevance of this data to multidisciplinary project teams, management, and regulatory authorities as appropriate.

+ Ensures the scientific quality of pharmacometrics data in support of development program(s).

+ Performs other tasks and assignments as needed and specified by management.


**KNOWLEDGE/SKILLS/ABILITIES REQUIRED**


_* Minimum level of education and years of relevant work experience._


+ Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences, engineering, computer sciences or related disciplines and a minimum of 7 yrs of progressively responsible experience in pharmacometrics and model-informed drug development in a pharmaceutical, biotechnology or related environment OR a Masters degree in these same disciplines and a minimum of 10 years of progressively responsible experience in pharmacometrics and model-informed drug development in these same environments.


_* Special knowledge or skills needed and/or licenses or certificates required._


+ Applied understanding and experience in pharmacometrics, clinical pharmacology, and pharmacokinetics.

+ Proficiency in modeling software, such as WinNonlin, NLME, NONMEM, R, etc.

+ Demonstrated ability to perform PK/PD, popPK, dose-response, exposure-response, PBPK and other modeling as may be required.

+ Experience leading projects.

+ Demonstrated ability to write study reports and contribute to the writing of regulatory documents.

+ Demonstrated ability to independently lead projects.

+ Ability to influence without direct authority.

+ Excellent verbal and written communication and skills.

+ Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

+ Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

+ A strong understanding of regulatory guidelines for pharmacometrics to support drug development.

+ Ability to effectively and efficiently navigate conflicting priorities to adhere to project and team timelines.


**APPLY NOW!**

**For immediate consideration, please send your resume in a WORD document to gaut985@kellyservices.com, with job ID 8349525**


**\#** P1


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-06-24 Expires: 2022-09-01

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Remote Associate Director Pharmacometrics

Kelly Services
South Plainfield, NJ 07080

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