Associate Director Biostatistics - PMX

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Summary
We are 100 quantitative scientists supporting more than 80 clinical development projects in 10 therapeutic areas every day. As the Associate Director Pharmacometrics, you will drive the pharmacometric strategy for programs in multiple indications or a disease area. You will define the quantitative strategy that will be part of the Integrated Development Plans (IDP) for projects in Research and Early Development. In this role, you will perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches. You may manage a portfolio of projects at the disease area or indication level. You will set the strategy for informed decision making at early-stage project milestones, directly influencing drug development decisions with internal and external partners.

Summary
We are 100 quantitative scientists supporting more than 80 clinical development projects in 10 therapeutic areas every day. As the Associate Director Pharmacometrics, you will drive the pharmacometric strategy for programs in multiple indications or a disease area. You will define the quantitative strategy that will be part of the Integrated Development Plans (IDP) for projects in Research and Early Development. In this role, you will perform or supervise execution of the pharmacometrics strategy in those programs with focus on implementing model-informed drug development (MIDD) approaches. You may manage a portfolio of projects at the disease area or indication level. You will set the strategy for informed decision making at early-stage project milestones, directly influencing drug development decisions with internal and external partners.
About The Role
Your Key Responsibilities:

• Provide global strategic pharmacometrics leadership for integrated development plans of medium to high complexity, based on relevant technical and disease area knowledge
• Lead and drive PMX contributions to integrate relevant technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies
• Drive and coordinate the synthesis and integration of pharmacometrics information to support transition of drug development milestones / decision boards; identify alternative strategic options to mitigate risk on clinical programs
• Act as the PMX representative on early project teams and contribute to interactions with Health Authorities (e.g., responsible for PMX contributions to Briefing books, Investigator brochures, etc.)
• Proactively interact with partner line functions (pharmacologists, clinicians, statisticians, preclinical modelers, biomarker experts) on quantitative pharmacology aspects
• Plan, develop, execute and document PMX analyses
• Contribute to Integrated Evidence generation by leveraging disease progression and PKPD modeling techniques using various data sources (e.g., literature or Real-World Data); use historical data and knowledge for early benchmarking of assets
• Represent PMX in due-diligence teams to evaluate in-licensing opportunities

Essential Requirements

• Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent) with 6+ years’ experience in clinical drug development applying model-based methods using NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation in academia and/or industry
• Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas
• Diverse experience in pharma industry on incorporation of MIDD strategies into drug development plans across all phases and answering challenging questions on dose and regimen justification, study design, safety analysis among others
• Track record of contributions to external whitepapers/ policy shaping best practice in pharmacometrics. Internally and externally established track record of developing/establishing pharmacometrics excellence
• Scientific leadership skills demonstrated in facilitating and optimizing the clinical development strategy. Track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies

Why Novartis
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: Receive
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Pharmaceutical Manufacturing

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