Senior Specialist, Infectious Disease and Vaccines, Quantitative Pharmacology and Pharmacometrics (Hybrid)
USA - Pennsylvania - West Point
Job Description
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. Senior
Senior 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 candidates
Developing 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 decisions
Severs as a QP2 representative while being mentored by QP2 senior staff on drug and vaccine development teams to manage functional deliverables for assigned programs
On 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 academia
An 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 language
Proficiency in written and verbal communication
Preferred experience and skills:
Knowledge of infectious diseases
Experience in performing population PK and PK/PD analyses
Experience with standard pharmacometric software (e.g. NONMEM, Monolix, Phoenix, etc.)
Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
Scientific understanding of ADME and biopharmaceutic properties of biologics, small molecules, or non-traditional therapeutics
NOTICE FOR INTERNAL APPLICANTS
In 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.
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U.S. Hybrid Work Model
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”.
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 candidate’s relevant skills, experience, and education.
Expected US salary range:
$122,800.00 - $193,300.00Available 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.
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Employee Status:
RegularRelocation:
Domestic/InternationalVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid 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 Project ManagementPreferred Skills:
Job Posting End Date:
10/14/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
ApplyJob Profile
Hybrid Hybrid work Hybrid work model On-site
Benefits/PerksBonus eligibility Collaborative work environment Diverse workplace Equal opportunity employer Flexible work Flexible work arrangements Hybrid work Hybrid work model Inclusion Inclusive environment Insurance Meetings Mentoring Mentorship opportunities Paid holidays Professional development Retirement benefits Separation benefits package Sick Days Vacation
Tasks- Apply quantitative approaches
- Business intelligence
- Collaboration
- Communication
- Data Analysis
- Database design
- Data modeling
- Data visualization
- Develop pharmacokinetics and pharmacodynamics models
- Innovation
- Leadership
- Machine Learning
- Mentoring
- Perform clinical trial simulations
- Problem solving
- Project management
- Relationship Management
- Software development
Access ADME Analysis Biologics Biology Biomedical Engineering Biopharmaceutical Biopharmaceutic properties Biostatistics Business Intelligence Business Operations Chemistry Clinical Clinical Pharmacokinetics Clinical Pharmacology Clinical Trial Design Clinical trial simulations Collaboration Commercial Communication Computational Computational Biology Data Data analysis Database Database design Data engineering Data Modeling Data Science Data Visualization Design Development Drug Development Education Engineering Experimental Experimental Design Exposure-response Inclusion Independence Innovation Law Leadership Learning Machine Learning Management Manufacturing Mathematical problem solving Mathematics Matlab Mentoring Model-based meta-analysis Modeling Monolix Nonmem Operations Pharmaceutical Pharmaceutical Sciences Pharmacodynamics Pharmacokinetics Pharmacology Pharmacometrics Phoenix PK/PD Population Pharmacokinetics Programming Project Management Python Quantitative Pharmacology Quantitative system pharmacology R Regulatory Relationship Management Research Science Small Molecules Software Development Statistics Talent Acquisition Teams Therapeutics Vaccine Development Vaccines Verbal communication Viral dynamics modeling Visualization Waterfall
Experience2-4 years
EducationAS Biology Biomedical Engineering Biostatistics Business Chemistry Computational Biology Data Science Engineering Equivalent Equivalent degree Management Mathematics MS Pharmaceutical Sciences Pharmacology Pharmacometrics Pharm.D Ph.D. Science Statistics
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9