Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. As a Director, Quantitative Pharmacology, Pharmacometrics you will play a critical role in advancing drug development by serving as the key expert on all pharmacometrics matters relating to assigned clinical projects. You will oversee all pharmacometrics activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. In this position, you will lead analysis, execution and reporting of pharmacometrics studies. You will provide input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. The Director of Quantitative Pharmacology, Pharmacometrics loosely interacts with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. This position is based in Rockville, Maryland or Princeton, New Jersey. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. Remote options will be considered for US candidates. Job Description: Author/reviewer of clinical pharmacology and pharmacometrics submission documents and representative of the department at different product development team meetings. 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. Lead pharmacometrics activities related to study design, protocol development, study execution, reporting and interpretation of data. Conduct population PK, PK/PD analysis and modeling and simulation. Leads pharmacometrics team members and participate in activities related to analysis and reporting of population PK and PK/PD analyses. Leads pharmacometrics and modeling and simulation activities to support optimizing clinical study dose, dosing regimen and design. Lead development of pharmacometrics sections of clinical pharmacology documents 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 sample management, pharmacogenomics and biomarker development and provide analysis support related to PK and PK/PD. 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 pharmacometrics activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices. Training and mentoring of staff related to population PK and PK/PD modeling. Serve as pharmacometrics lead on multiple project teams and as a team member on other key projects as needed and lead model-based drug development strategies for ongoing projects. Minimum Qualifications: PhD in pharmacometrics (or a related area such as pharmacokinetics, clinical pharmacology, pharmacology, or a related area) with a minimum of 8-10 years of industry experience in these areas. Strong technical and hands on experience in population PK and PK/PD modeling. In-depth knowledge of pharmacometrics, population PK and PK/PD modeling, clinical pharmacology, drug metabolism, biopharmaceutics, and bioanalytical chemistry. Hands PK and PK/PD analysis and statistical analysis using NonMEM, Phoenix NLME, Julia, R etc. Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements. Good working knowledge of formulation development, drug development and clinical development. Current awareness of the latest developments in clinical pharmacology and guidance documents. 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 technical and hands on experience related to pharmacometrics, population PK and PK/PD modeling. MS1 LI-Hybrid Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative. Minimum $179,721.00 - Maximum $268,755.00, plus incentive opportunity: 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. 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. 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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic . If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability . You can request reasonable accommodations by contacting Accommodation Request . 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. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.