13 days old

Senior Scientist

Kelly Services
Cambridge, MA 02238
Kelly Services has provided outstanding employment opportunities to the most talented individuals in the marketplace. Today, we are proud to offer a full-time **Senior Scientist** position in **Cambridge, MA** !


The primary responsibility is to provide clinical pharmacology support to companys cross-TA programs, including but not limiting to utilizing pharmacometrics approaches.

The work may include:

a. Define M&S objective and write M&S analysis plan, if necessary, in collaboration with the Program Clin Pharm Leader

b. Perform hands-on population-based PK/PD model analyses for both clinical data and non-clinical data. Modeling non-clinical data is for the human translation purpose. To achieve better translational modeling purpose, appropriate communication and collaboration with non-clinical teams is expected.

c. Interpret and present M&S results to the Program Team, and to Senior Management Team, if necessary, in collaboration with Program Clin Pharm Leader

d. Document and archive the M&S codes and/or files properly and write the M&S reports if needed

e. Performing hands-on exposure-response (correlation) analyses using statistical approaches, such as logistic analysis, survival analysis, will be considered

f. Performing hands-on PBPK modeling will also be considered

2. Serve as the SME of pharmacometrics:

a. Support M&S out-outsourcing process, if needed.

b. Keep up-to-date knowledge of model-informed drug development (MIDD) with focus on Clinical pharmacology, biopharmaceutics, PKPD & other related new quantitative sciences

c. Advocate MIDD concepts to various program teams, line functions and management teams

d. Provide training to Clinical Pharmacology Department colleagues who want to develop the skills in pharmacometrics

3. Contribute to the clinical pharmacology activities of certain company programs, including:

a. Develop and execute clinical pharmacology development strategy

b. Design clinical pharmacology trials, analysis of data, report and interpret results

c. Develop a clinical pharmacology package that enables global product registration

d. Participate in the global healthy authority Interactions


Educations and background:

This position requires a masters degree or higher. Educations in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering/Bioinformatics, Biostatistics or relevant Biological Sciences are preferred. Adequate educations or trainings in pharmacometrics, PK/PD or PBPK modeling is highly preferred.

2-3 year industry experiences is required. More experiences such as 4+ years can also be considered as the Principle Scientist position.

Adequate pharmacometric skills and keen interest in drug development is required.

Key required skills:

Advanced understanding of PK, PD, PK/PD, and Translational Medicine

Proficiency in M&S analysis methods (population PK/PD, PBPK etc) and proficiency in using relevant modelling tools (e.g., NONMEM, Monolix, R, Phoenix NLME, SimCYP, Gastro-Plus, MATLAB, Winnonlin or similar software)

Have experience analyzing data describing biological, PK/PD, or disease systems, preferably in but not limited to the Oncology or Immunology or CNS therapeutic areas.

Understanding in biologics PK/ADME and how to model the related processes

Team-worker with the ability to perform M&S work with minimal guidance. Good oral and written communication skills.

Understanding of overall drug development process including MIDD and the overall drug R&D process is preferred

**To learn more, apply today!**

**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** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-19 Expires: 2022-10-20

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Senior Scientist

Kelly Services
Cambridge, MA 02238

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