Senior Principal Scientist, Clinical Pharmacology

Bridgewater, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesnt just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

The Senior Principal Scientist will lead the strategy execution and report of Clinical Pharmacology studies and Pharmacometrics deliverables for new development post-marketing and maintenance of business projects

Key technical responsibilitiesinclude the design and implementation of Clinical Pharmacology and/or Modeling & Simulation (M&S) strategies
The individual will discuss Clinical Pharmacology and Pharmacometrics information with R&D staff senior management and consultants in order to convey key concepts and facilitate understanding of results and risks
Integrate biology pharmacology toxicology biomarker and clinical information to generate data and knowledge supporting the generation and implementation of translational models
The individual will represent the clinical pharmacology function in cross-functional teams and will provide support for the planning implementation and organization of project deliverables for internal decision making as well as for regulatory submissions

Responsibilities:

Lead and support the design conduct interpretation and reporting of clinical pharmacology studies including but not limited to PK food effect drug-drug interactions TQT and hepatic/renal impairment studies
Lead pharmacokinetics (PK) and/or pharmacodynamics (PD) aspects of study plans and integrate quantitative approaches into drug development projects
Conduct exploratory PK and pharmacometrics analyses such as Physiologically-based Pharmacokinetic (PBPK) or population PK (popPK) modelingto support therapeutic decisions trial design dosing strategies and post-approval changes
Manage CRO/vendors to execute PK/PD and pharmacometrics deliverables for regulatory submissions
Represent the Clinical Pharmacology function in cross functional teams including Project Management Clinical Operations Clinical/Medical Affairs Biostatistics Regulatory Affairs and Medical Writing
Collaborate closely with the clinical project team to manage Phase I-III and post-marketing studies
Other responsibilities may include planning writing and reviewing relevant sections of clinical documents such as study protocols analysis plans reports and regulatory documents (IBs INDs NDAs etc.)
Maintain awareness of emerging literature and science in computational approaches and applications as well as relevant regulatory guidances

Qualifications:

Ph.D. in Pharmacokinetics/Pharmacodynamics Clinical Pharmacology Pharmacometrics Pharmacology or related field or Pharm.D. with demonstrated clinical pharmacology and pharmacokinetic training and experience required. M.S. degrees with significant applicable experience will also be considered
PhD with minimum of 5 years of experience in clinical pharmacology and drug development in the pharmaceutical industry; Masters degree with 10 years
Experience in applying clinical pharmacology PK PD and pharmacometrics principles within drug development teams
Hands-on experience with non-compartmental and compartmental PK/PD analysis using Phoenix WinNonlin
Hands-on experience with one or more pharmacometrics analysis e.g. PBPK modeling population PK (popPK) modeling exposure-response (E-R) analysis and pharmacometrics software platforms (e.g. Simcyp GastroPlus NONMEM etc.)
Familiarity with LC/MS-based bioanalysis to support in vivo PK toxicity and PK/PD studies
Previous experience in gastroenterology dermatology and/or inflammatory indications preferred
Ability to communicate effectively and with confidence and work in a matrix environment

The range of starting base pay for this role is 167K-229K. Actual starting pay will be based on a wide range of factors including but not limited to relevant skills experience qualifications education and addition to base pay this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

Benefits package includes a comprehensive Medical (includes Prescription Drug) Dental Vision Flexible Spending Accounts 401(k) with matching company contribution discretionary time off paid sick time stock purchase plan tuition reimbursement parental leave short-term and long-term disability life insurance accidental death & dismemberment insurance paid holidays employee referral bonuses and employee discounts.

#LI-hybrid

We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates collaboration.

Required Experience:

Staff IC

Key technical responsibilitiesinclude the design and implementation of Clinical Pharmacology and/or Modeling & Simulation (M&S) strategies
The individual will discuss Clinical Pharmacology and Pharmacometrics information with R&D staff senior management and consultants in order to convey key concepts and facilitate understanding of results and risks
Integrate biology pharmacology toxicology biomarker and clinical information to generate data and knowledge supporting the generation and implementation of translational models
The individual will represent the clinical pharmacology function in cross-functional teams and will provide support for the planning implementation and organization of project deliverables for internal decision making as well as for regulatory submissions

Responsibilities:

Lead and support the design conduct interpretation and reporting of clinical pharmacology studies including but not limited to PK food effect drug-drug interactions TQT and hepatic/renal impairment studies
Lead pharmacokinetics (PK) and/or pharmacodynamics (PD) aspects of study plans and integrate quantitative approaches into drug development projects
Conduct exploratory PK and pharmacometrics analyses such as Physiologically-based Pharmacokinetic (PBPK) or population PK (popPK) modelingto support therapeutic decisions trial design dosing strategies and post-approval changes
Manage CRO/vendors to execute PK/PD and pharmacometrics deliverables for regulatory submissions
Represent the Clinical Pharmacology function in cross functional teams including Project Management Clinical Operations Clinical/Medical Affairs Biostatistics Regulatory Affairs and Medical Writing
Collaborate closely with the clinical project team to manage Phase I-III and post-marketing studies
Other responsibilities may include planning writing and reviewing relevant sections of clinical documents such as study protocols analysis plans reports and regulatory documents (IBs INDs NDAs etc.)
Maintain awareness of emerging literature and science in computational approaches and applications as well as relevant regulatory guidances

Qualifications:

Ph.D. in Pharmacokinetics/Pharmacodynamics Clinical Pharmacology Pharmacometrics Pharmacology or related field or Pharm.D. with demonstrated clinical pharmacology and pharmacokinetic training and experience required. M.S. degrees with significant applicable experience will also be considered
PhD with minimum of 5 years of experience in clinical pharmacology and drug development in the pharmaceutical industry; Masters degree with 10 years
Experience in applying clinical pharmacology PK PD and pharmacometrics principles within drug development teams
Hands-on experience with non-compartmental and compartmental PK/PD analysis using Phoenix WinNonlin
Hands-on experience with one or more pharmacometrics analysis e.g. PBPK modeling population PK (popPK) modeling exposure-response (E-R) analysis and pharmacometrics software platforms (e.g. Simcyp GastroPlus NONMEM etc.)
Familiarity with LC/MS-based bioanalysis to support in vivo PK toxicity and PK/PD studies
Previous experience in gastroenterology dermatology and/or inflammatory indications preferred
Ability to communicate effectively and with confidence and work in a matrix environment

#LI-hybrid

Required Experience:

Staff IC