Senior Manager, Clinical Pharmacology and Quantitative Pharmacology (CPQP)

AstraZeneca • Mississauga, ON

12d • Hybrid

About The Position

The Senior Manager CPQP position with a focus on PK-PD Modeling and Pharmacometrics (PMX) is responsible for developing and executing Modeling & Simulation (M&S) plans and strategies, and exposure response analyses for compounds from early-stage (first-in-human up to proof-of-concept) to late-stage clinical development (proof-of-concept up to post-market). This role operates within cross-functional drug discovery and development project teams, in close collaboration with colleagues in Clinical Pharmacology and Safety Sciences (CPSS), Translational Medicine, Clinical Development, Biostatistics, Research, and other colleagues within the Alexion R&D organization. This position will play a key role in strengthening the PMX and Modeling capability within Alexion by contributing to the continuous improvement of pharmacometrics technical skillset, computational infrastructure, and the strategic use of M&S methodologies across projects and disease areas. It will also optimize the utilization of external PMX resources. The role is responsible for project-related M&S assignments, either executed independently or in collaboration with external PMX CROs. The incumbent will be responsible for the preparation of population PK/PD reports and corresponding regulatory submission documents. They will manage multiple development projects simultaneously and participate in discussions and presentations to senior management.

Requirements

• A PhD, degree or equivalent in quantitative sciences.
• 2+ years pharmaceutical industrial and/or postdoctoral experiences in the related disciplines of clinical pharmacology, PKPD, and QSP.
• Excellent hands-on knowledge in R and/or SAS, NONMEM.
• Excellent knowledge in Matlab, Mathematica, or other QSP related software or computing platform.
• Under manager’s guidance, to become well-versed at analyzing, summarizing, plotting complex data to identify trends important for drug development.
• Track record of applying quantitative system pharmacology methodologies in a drug R&D context.
• Track record of publishing M&S work.
• Excellent written and verbal communication skills.

Nice To Haves

• Experience from PMX approaches in hematology, nephrology, transplant, neurology, ophthalmology, and/or gene therapy rare diseases preferred.
• Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacology/cell biology/immunology, or relevant discipline.
• Background in clinical pharmacology or bioengineering is desired.

Responsibilities

• Develop and execute population PK, PKPD, exposure response, dose selections for phase 3 strategies/plans and corresponding models for the pharmacometrics function from early clinical studies to Phase IV studies.
• Develop quantitative system pharmacology strategies/plans and corresponding models for target identification, and compound design/characterization, translation from preclinical to FIH dose selection.
• As M&S project lead in one or more cross functional development teams, develop and execute M&S strategies/plans fully integrated with the overall preclinical and clinical development plans.
• Using state-of-the-art M&S methodologies, strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with CPSS, Biostats, Translational Medicine, Clinical Development, Research, and other quantitative disciplines.
• Lead an internal matrix team(s) in building quantitative systems biology/pharmacology (QSP) models to support activities from early discovery to FIH and beyond, in collaboration with leading external QSP service providers.
• Perform population PK, PKPD-analyses, clinical trial simulations and other model-based analyses when appropriate.
• Initiate and coordinate outsourced M&S activities on a regular basis.
• Prepare population PK/PD reports and corresponding regulatory submission documents.

Benefits

• Annual base salary for this position ranges from 110,999.20 to 145,686.45.
• Annual Variable Pay Bonus/Short Term Incentive opportunity.
• Eligibility to participate in our equity-based long-term incentive program (if applicable to role).
• Competitive Flex Benefits & Retirement Savings Program.
• 4 weeks’ paid vacation.
• Annual Personal Days.
• Contract Benefits Program (for Fixed Term Contract/Temporary positions excluding students).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees