Associate Director, Quantitative Pharmacology, Clinical Pharmacology
Role Overview
Supports all clinical pharmacology activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions.
Supports study design, execution and reporting of clinical pharmacology and studies.
Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development.
Closely interacts 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. participates in pharmacometrics and simulation and modeling plans 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.
Key Skills for This Role
Full Job Posting
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.
Qualifications
- 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
- 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 $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
- Application Deadline: This will be posted for a minimum of 5 business days.
- 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://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.
- Join Our Talent Community: Stay connected with Otsuka by joining our Talent Community. Tell us about your interests, and we’ll notify you about future opportunities that align with your background. https://community.hireez.com/cielo-otsuka/82cb3591
Preferred 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.
About Otsuka Pharmaceutical
Develops and manufactures innovative pharmaceutical and nutritional products.
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