Leads all clinical pharmacology activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Leads study design, execution and reporting of clinical pharmacology and studies. Sets strategy and provides input into strategy and activities related all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. Oversees interactions of clinical pharmacology team including direct reports with non-clinical, bioanalytical, genomics and translational sciences team members for design and execution of first-in-human, mass balance and drug interaction studies. Approver/reviewer of clinical pharmacology submission documents and representative of the department at different executive and product development team meetings. Participates in pharmacometrics and simulation and modeling strategy meetings and provide input on modeling and simulation activities. Interacts with early development and business development team members as well as external collaborators to assess/lead development and selection of pre-IND and early phase assets. Works with VP to set department strategy, growth and cross functional alignment.
- Leads all clinical pharmacology activities related to study design, protocol development, study execution, reporting and interpretation of data.
Review PK and PK/PD analysis.
- Work closely with pharmacometrics team members to set strategy and provides input related to analysis and reporting of PK and PK/PD.
- Oversees development of clinical pharmacology sections for regulatory filings including annual reports, investigator's brochure, IND/NDA applications and pediatrics development plans.
- Oversees interactions of clinical pharmacology with bioanalytical team members on activities related to assay development, sample management, pharmacogenomics and biomarker development.
- Oversees interactions 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 direct reports for clinical pharmacology (Sr Scientist- Director) related to project activities and deliverables, budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.
- Training and mentoring of direct reports in clinical pharmacology
- Serve as clinical pharmacology lead and pharmacometrics representative on multiple project teams and support model-based drug development strategies for ongoing projects.
Knowledge/ Experience and Skills:Knowledge and Competencies
• In-depth knowledge of clinical pharmacology
, PK, PD, drug metabolism, biopharmaceutics
, and bioanalytica
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
• Must be able to apply scientific knowledge (in the areas specified above) to further the company's products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.
• Strong leadership experience related to clinical pharmacology
• Strong organization skills.
• Strong communication skills.
• Flexibility to react rapidly to changing situations/environment.
PhD in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) with a minimum of 15
years of experience in these areas. Experience in population PK and PK/PD modeling and statistical models a plus.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.Equal Opportunity Employer
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.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.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.Valid Proof of COVID-19 Vaccination or Accommodation
The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.Statement Regarding Job Recruiting Fraud Scams
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