Associate Director, Quantitative Pharmacology, Clinical Pharmacology Job at Otsuka Pharmaceutical Co.
Job Summary
Support all clinical pharmacology activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Support study design, execution and reporting of clinical pharmacology and studies. Provide input into all phases of drug development including dose finding, dose optimization, exposure-response and pediatric development. interact with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. Author of clinical pharmacology submission documents and representative of the department at different product development team meetings. Participate in pharmacometrics and simulation and modeling plans and contribute to modeling and simulation activities. Interact with early development and business development team members and external collaborators to assess/lead development and selection of pre-IND and early phase assets.
Job Description
Support clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data.
Conduct PK and PK/PD analysis.
Work with pharmacometrics team members and provide input related to analysis of PK and PK/PD.
Author development of clinical pharmacology sections for regulatory filings including annual reports, investigator's brochure, IND/NDA applications and pediatrics development plans.
Work with bioanalytical team members on activities related to assay development, sample management, pharmacogenomics and biomarker development.
Work with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations.
Manage clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.
Mentor staff related to clinical pharmacology
Serve as clinical pharmacology lead and pharmacometrics representative on multiple project teams and support model-based drug development strategies for ongoing projects.
Qualifications/ Required
Knowledge/ Experience:
In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry, Hands PK and PK/PD analysis and, Phoenix NLME.
Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis.
Great working knowledge of formulation development, drug development and clinical development.
Current awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents.
Skills
Will apply scientific knowledge (in the areas specified above) to further our products, identify core problems, and apply analysis.
Experience related to clinical pharmacology.
Educational Qualifications
PhD, PharmD, MS in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) with a minimum of 5 years of experience in these areas.
Experience in population PK and PK/PD modeling and statistical models a plus.
#MS1
Annual Salary :
Minimum $0.00 - Maximum $0.00, plus annual incentive: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Company benefits: Comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.
Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Statement Regarding Job Recruiting Fraud Scams :
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
Please Note :
bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
Support all clinical pharmacology activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Support study design, execution and reporting of clinical pharmacology and studies. Provide input into all phases of drug development including dose finding, dose optimization, exposure-response and pediatric development. interact with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. Author of clinical pharmacology submission documents and representative of the department at different product development team meetings. Participate in pharmacometrics and simulation and modeling plans and contribute to modeling and simulation activities. Interact with early development and business development team members and external collaborators to assess/lead development and selection of pre-IND and early phase assets.
Job Description
Support clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data.
Conduct PK and PK/PD analysis.
Work with pharmacometrics team members and provide input related to analysis of PK and PK/PD.
Author development of clinical pharmacology sections for regulatory filings including annual reports, investigator's brochure, IND/NDA applications and pediatrics development plans.
Work with bioanalytical team members on activities related to assay development, sample management, pharmacogenomics and biomarker development.
Work with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations.
Manage clinical pharmacology activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.
Mentor staff related to clinical pharmacology
Serve as clinical pharmacology lead and pharmacometrics representative on multiple project teams and support model-based drug development strategies for ongoing projects.
Qualifications/ Required
Knowledge/ Experience:
In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry, Hands PK and PK/PD analysis and, Phoenix NLME.
Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements and PK/PD analysis.
Great working knowledge of formulation development, drug development and clinical development.
Current awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents.
Skills
Will apply scientific knowledge (in the areas specified above) to further our products, identify core problems, and apply analysis.
Experience related to clinical pharmacology.
Educational Qualifications
PhD, PharmD, MS in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) with a minimum of 5 years of experience in these areas.
Experience in population PK and PK/PD modeling and statistical models a plus.
#MS1
Annual Salary :
Minimum $0.00 - Maximum $0.00, plus annual incentive: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Company benefits: Comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.
Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
Statement Regarding Job Recruiting Fraud Scams :
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
Please Note :
bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.