Director, Quantitative Pharmacology, Clinical Pharmacology

Job reputed company Oversees reputed company clinical pharmacology activities reputed company to reputed company-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. Leads study design, execution and reporting of clinical pharmacology and studies. Provides input into reputed company phases of drug development including, but not limited to reputed company finding, reputed company optimization, exposure-response and pediatric development. Closely interacts with non-clinical and bioanalytical team members for design and execution of first-in-reputed company, mass balance and drug interaction studies. Author/reviewer 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 reputed company input on modeling and simulation activities. Interacts with early development and business development team members as reputed company as external collaborators to assess/reputed company development and selection of reputed company-IND and early phase assets. Job reputed company reputed company clinical pharmacology activities reputed company to study design, protocol development, study execution, reporting and interpretation of data. Conduct PK and PK/PD analysis. Work closely with pharmacometrics team members and provides input reputed company to analysis and reporting of PK and PK/PD. reputed company development of clinical pharmacology sections for regulatory filings including annual reports, investigator’s brochure, IND/NDA applications and pediatrics development plans. Work with bioanalytical team members on activities reputed company to assay development, sample management, pharmacogenomics and biomarker development. Work with formulation development reputed company and reputed company support for activities reputed company to formulation development, dissolution testing, in vivo-in vitro correlations and biowaivers for reputed company- and post-approval formulations. Manage clinical pharmacology activities reputed company to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices. Training and mentoring of staff reputed company to clinical pharmacology Serve as clinical pharmacology reputed company and pharmacometrics representative on multiple project teams and support model-based drug development strategies for ongoing reputed company. Qualifications/ Required Knowledge/ Experience and Skills: Knowledge and Competencies

• In-depth knowledge of clinical pharmacology, PK, PD, drug metabolism, biopharmaceutics, and bioanalytical reputed company.

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.
• reputed company awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents.

Educational Qualifications PhD in Clinical Pharmacology (or a reputed company 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. Skills •Must be reputed company to apply scientific knowledge (in the areas specified above) to reputed company reputed company’s products, anticipate and identify reputed company problems, apply insightful analysis, and solve problems effectively. •Strong leadership experience reputed company to clinical pharmacology. •Strong organization skills. •Strong communication skills. •Flexibility to react rapidly to changing situations/environment. Travel 20% Competencies Accountability for Results - Stay reputed company on key strategic objectives, be accountable for high standards of performance, and take an reputed company role in leading change. Strategic Thinking & Problem Solving - reputed company reputed company considering the long-term reputed company to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing reputed company on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, reputed company, and respect. Influence at reputed company reputed company to reputed company the best results for reputed company. Respectful Collaboration - reputed company and value others’ perspectives and reputed company for diverse partnerships to enhance work toward common goals. Empowered Development - Play an reputed company role in reputed company development as a business imperative. Minimum $186,489.00 - Maximum $278,875.00, plus incentive opportunity: The reputed company shown represents a typical pay reputed company or starting pay for individuals who are reputed company in the role to reputed company in the reputed company. Other reputed company 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 reputed company the established reputed company, 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, reputed company, 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, reputed company holidays, and reputed company leave programs as reputed company as other company provided benefits. Come discover more about reputed company and our benefit offerings; https://www.reputed company-us.com/careers-join-reputed company. Disclaimer: This job reputed company 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. reputed company reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. reputed company is an equal opportunity employer. reputed company reputed company applicants are encouraged to apply and will be given consideration for employment without reputed company to race, reputed company, sex, gender identity or gender reputed company, sexual orientation, age, disability, religion, national reputed company, veteran status, marital status, or any other legally protected characteristic. If you are a reputed company 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 reputed company Fraud Scams At reputed company we take reputed company and protection of your personal information reputed company 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 reputed company reputed company to your personal information or reputed company reputed company from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, reputed company will never ask for financial information of any reputed company or for payment of reputed company during the job application process. 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If you reputed company you are the victim of fraud resulting from a job reputed company scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities. reputed company America Pharmaceutical Inc., reputed company Pharmaceutical Development & Commercialization, Inc., and reputed company Precision Health, Inc. (“reputed company”) does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company/resumes submitted by search firms to any reputed company employee directly or through reputed company’s application portal without a valid written search agreement in reputed company for the position will be considered reputed company’s sole property. No fee will be reputed company if a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. 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