Senior Director, Clinical Pharmacology
Otsuka Pharmaceutical

Princeton, New Jersey

Posted in Pharmaceuticals


This job has expired.

Job Info


Job Summary

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.

Job Description

  • 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.


Qualifications/ Required

Knowledge/ Experience and Skills:

Knowledge and Competencies
• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical chemistry.

Hands PK and PK/PD analysis and, Phoenix NLME, etc.

• 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.

Travel 20%

Educational Qualifications

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.

#JB1

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

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.


This job has expired.

More Pharmaceuticals jobs


Akorn 2
Amityville, New York
Posted about 2 hours ago

Akorn 2
Amityville, New York
Posted about 2 hours ago

Akorn 2
Amityville, New York
Posted about 2 hours ago

Improve Job Search

Subscribe to job alerts and add your resume to our resume database for employers!


Sign up now