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Company:
Merck Sharp and Dohme MSD
Category:
Science
Posted: July 1, 2024
Senior Specialists in the Infectious Disease and Vaccines group in the department of Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to enable drug-development decision-making from post-Preclinical Candidate (PCC) to worldwide registration.
SeniorSenior Specialists in QP2-IDVAX will work in collaborative teams with more experienced scientists across disciplines, and are expected to have or develop expertise in one or more areas necessary to perform the primary responsibilities of the role including:
Applying quantitative approaches to develop and implement translational clinical pharmacokinetics and pharmacodynamics of new drug and vaccine candidatesDeveloping and executing pharmacokinetics and pharmacodynamics modelling approaches, such as noncompartmental analysis, population pharmacokinetic, exposure-response, quantitative system pharmacology, viral dynamics modeling, model-based meta-analysis, and other model-based analyses.Perform clinical trial simulations to inform dose selection and go/no-go decisionsSevers as a QP2 representative while being mentored by QP2 senior staff on drug and vaccine development teams to manage functional deliverables for assigned programsOn the job, you will begin to develop a comprehensive understanding of global regulatory expectations of drug and vaccine development, including clinical trial design, clinical pharmacology, biomarker plans, and model-based drug development approaches.
You will also develop leadership skills in areas such as mentoring, managing a program, project, or initiative.
In addition to the responsibilities outlined above, Senior Specialists are expected to demonstrate good communication skills, collaborating within QP2-IDVAX and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact decisions of drug development teams.The ideal candidate is collaborative, eager to learn and not intimidated by tough scientific challenges.
Excellent communication skills both written and verbal are required including the ability to clearly present scientific data in cross functional group settings.
QP2 offers a unique opportunity to accelerate your professional career as a quantitative drug developer taking advantage of our end-to-end pipeline support in one of the world s most research-intensive biopharmaceutical companies.Minimum required education:
A Ph.D.
or equivalent degree - OR- a PharmD or equivalent degree with at least two years of experience - OR- a MS or equivalent degree with at least four years of experience, where experience means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academiaAn educational background in PK/PD, pharmaceutical sciences, pharmacometrics, mathematics, statistics/ biostatistics, computational biology/chemistry, or chemical/biomedical engineering.Required experience and skills:
Proficiency in R, NONMEM, Matlab, Python, or other similar programming languageProficiency in written and verbal communicationPreferred experience and skills:
Knowledge of infectious diseasesExperience in performing population PK and PK/PD analysesExperience with standard pharmacometric software (e.g.
NONMEM, Monolix, Phoenix, etc.)Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statisticsScientific understanding of ADME and biopharmaceutic properties of biologics, small molecules, or non-traditional therapeuticsNOTICEFORINTERNALAPPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERECurrent Contingent Workers apply HEREUS 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.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.
All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
For more information about personal rights under the U.S.
Equal Opportunity Employment laws, visit:
EEOC Know Your RightsEEOC GINA Supplement Pay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State ActsU.S.
Hybrid Work ModelEffective 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 b.
SeniorSenior Specialists in QP2-IDVAX will work in collaborative teams with more experienced scientists across disciplines, and are expected to have or develop expertise in one or more areas necessary to perform the primary responsibilities of the role including:
Applying quantitative approaches to develop and implement translational clinical pharmacokinetics and pharmacodynamics of new drug and vaccine candidatesDeveloping and executing pharmacokinetics and pharmacodynamics modelling approaches, such as noncompartmental analysis, population pharmacokinetic, exposure-response, quantitative system pharmacology, viral dynamics modeling, model-based meta-analysis, and other model-based analyses.Perform clinical trial simulations to inform dose selection and go/no-go decisionsSevers as a QP2 representative while being mentored by QP2 senior staff on drug and vaccine development teams to manage functional deliverables for assigned programsOn the job, you will begin to develop a comprehensive understanding of global regulatory expectations of drug and vaccine development, including clinical trial design, clinical pharmacology, biomarker plans, and model-based drug development approaches.
You will also develop leadership skills in areas such as mentoring, managing a program, project, or initiative.
In addition to the responsibilities outlined above, Senior Specialists are expected to demonstrate good communication skills, collaborating within QP2-IDVAX and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact decisions of drug development teams.The ideal candidate is collaborative, eager to learn and not intimidated by tough scientific challenges.
Excellent communication skills both written and verbal are required including the ability to clearly present scientific data in cross functional group settings.
QP2 offers a unique opportunity to accelerate your professional career as a quantitative drug developer taking advantage of our end-to-end pipeline support in one of the world s most research-intensive biopharmaceutical companies.Minimum required education:
A Ph.D.
or equivalent degree - OR- a PharmD or equivalent degree with at least two years of experience - OR- a MS or equivalent degree with at least four years of experience, where experience means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academiaAn educational background in PK/PD, pharmaceutical sciences, pharmacometrics, mathematics, statistics/ biostatistics, computational biology/chemistry, or chemical/biomedical engineering.Required experience and skills:
Proficiency in R, NONMEM, Matlab, Python, or other similar programming languageProficiency in written and verbal communicationPreferred experience and skills:
Knowledge of infectious diseasesExperience in performing population PK and PK/PD analysesExperience with standard pharmacometric software (e.g.
NONMEM, Monolix, Phoenix, etc.)Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statisticsScientific understanding of ADME and biopharmaceutic properties of biologics, small molecules, or non-traditional therapeuticsNOTICEFORINTERNALAPPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.
Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERECurrent Contingent Workers apply HEREUS 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.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.
All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
For more information about personal rights under the U.S.
Equal Opportunity Employment laws, visit:
EEOC Know Your RightsEEOC GINA Supplement Pay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State ActsU.S.
Hybrid Work ModelEffective 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 b.
Read the full job description and apply online on the recuiter's web-site
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