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, Clinical Pharmacology, you will oversee all clinical pharmacology activities related to pre-IND, IND, phase1-3, Pharmacokinetics (PK) , Pharmacokinetics-Pharmacodynamics (PK/PD) and regulatory submissions. You will lead study design, execution and reporting of clinical pharmacology and studies. You will contribute to all phases of drug development including dose finding, dose optimization, exposure-response and pediatric development. You will interact with non-clinical, translational medicine, and biomarker/bioanalytical team members for design and execution of first-in-human, proof of concept (PoC), mass balance and drug interaction studies. The Director will author/review clinical pharmacology submission documents and representative of the department at different product development team meetings. You will participate in pharmacometrics and simulation and modeling plans and provide input on modeling and simulation activities. You will 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
Serve as clinical pharmacology lead on multiple cross-functional project teams, plan and optimize clinical pharmacology strategies and integrate them into clinical development plans to support drug development and regulatory packages .
Lead clinical pharmacology activities related to study design, protocol development, study execution, data interpretation and study reporting.Conduct or oversee PK and PK/PD analysis using professional software, e.g., WinNonLin Phoenix. Responsible for ensuring appropriate PK-PD analysis is planned, performed and presented. Author PK reports that are integrated into clinical and regulatory documents.
Lead development of clinical pharmacology sections for regulatory filings, including annual reports, investigator's brochure, IND/NDA/BLA applications and pediatrics development plans in compliance with relevant guidelines and standards.
Work with pharmacometricians, support model-based drug development (MIDD) strategies, and provide input to PK and PK/PD modeling analysis to support dose selection, efficacy and safety assessments.
Responsible for use of innovative analytical methods to integrate knowledge of PK , PD , patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics, biomarker, statistics and clinical development functions (as relevant).
Interact cross-functionally across other key disciplines involved in drug development including nonclinical pharmacology/toxicology, ADME, clinical, regulatory, and CMC. Work with formulation, biomarker and bioanalytical team members on activities related to formulation, development, assay development, sample management, Pharmacogenomics (PGx) and biomarker strategy development.
Train and mentor junior team members in Quantitative Pharmacology team
Qualifications/ Required Knowledge/ Experience and Skills:
Knowledge and Competencies
In-depth knowledge of clinical pharmacology , PK, PD, drug metabolism, biopharmaceutics , and bioanalytica l chemistry.
Hands-on experiences in PK and PK/PD analysis and using professional software, Phoenix NLME, etc.
Excellent working knowledge of phase I study design, clinical trial operations, multi-region regulatory requirements and PK/PD analysis.
Practical working experience in a multi-discipline project team, familiar with cross-functional collaboration.
Great working knowledge of formulation development, clinical drug development and regulatory process.
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 10 years of experience in these areas. Experience in population PK and PK/PD modeling and statistical models a plus.
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 $183,335.00 - Maximum $274,160.00, 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, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, 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 ([email protected]) .
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