Associate Director Pharmacometrics

Novartis; Dalkeith; Hybrid; GBP 100,000 - 125,000; Full time

Job summary

An established industry player is seeking an Associate Director of Pharmacometrics to lead strategic initiatives in clinical development. This pivotal role encompasses driving pharmacometric strategies, ensuring alignment across global project teams, and influencing drug development decisions. With a commitment to innovation and collaboration, this position offers the opportunity to impact patient outcomes significantly. Join a community dedicated to reimagining medicine and improving lives through cutting-edge science and teamwork. If you are passionate about making a difference and possess a strong background in pharmacometrics, this is the perfect opportunity for you.

Qualifications

• 6+ years of experience in model-based drug development.
• Ph.D. in a relevant field with significant modeling content.

Responsibilities

• Drive pharmacometrics strategy for clinical programs across multiple indications.
• Lead pharmacometrics contributions to regulatory submissions.

Skills

Pharmacometric methodologies

Model-based methods

Scientific leadership

Data analysis

Education

Ph.D. in pharmacology, biology, engineering, mathematics, or statistics

Job description

This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Summary

Leads the execution and delivery of pharmacometrics tasks on assigned projects within (early/full) clinical development. Together with the leadership, s/he is responsible for the discussion and implementation of pharmacometric methodologies that optimally address the research and development objectives on assigned projects.

About the Role

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together!

The Role

As an Associate Director Pharmacometrics you will drive the pharmacometrics strategy for clinical programs in multiple indications or a disease area. As well as organizing the strategy for addressing pharmacometrics issues in regulatory submissions and integrated evidence generation directly influencing drug development and adoption decisions with internal and external partners.

This role offers hybrid working, requiring 3 days per week or 12 days per month in our London Office.

Key Accountabilities:

• You will provide global strategic pharmacometrics leadership for clinical development programs of medium to high complexity, based on relevant technical and disease area knowledge.
• You will represent the Global Project Teams internally and externally as the pharmacometrics expert.
• You will develop, write, and execute pharmacometrics analysis plans, and deliver reports on results.
• You will define and drive pharmacometrics contributions to regulatory/submission strategy and related documents (e.g., briefing books, summaries of clinical pharmacology/efficacy/safety, responses to Health Authority questions).
• You will represent PMX on all pharmacometrics aspects of the programs at global regulatory hearings/advisory committee meetings and other global regulatory interfaces.
• You will drive and coordinate the synthesis and integration of pharmacometrics information to support transition of drug development milestones / decision boards. As well as identify alternative strategic options to mitigate risk on clinical programs.
• You will lead and contribute to Integrated Evidence generation by leveraging disease progression and PKPD modeling techniques using varied data sources, including Real World Data.
• You will contribute to various internal and external initiatives on use of PMX techniques in support of Evidence Generation.
• You will ensure that the Analytics team (biometrician, data management, database programming, programming, medical and scientific writing) are aligned on the pharmacometrics strategy, execution, and delivery of assigned projects.

Your Experience

• Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a field with significant modeling-related content (or equivalent).
• More than 6 years' experience in applying model-based methods in pre-clinical and clinical drug development.
• Track record of contributions to external whitepapers/ policy shaping best practice in pharmacometrics. Internally and externally established track record of developing/establishing pharmacometrics excellence.
• Experience in contributing to global scientific improvement/change initiatives.
• 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: 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?

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally.