Senior Principal Pharmacometrics

Novartis Farmacéutica; London; On-site; GBP 70,000 - 90,000; Full time

Job summary

A global pharmaceutical company in London seeks a Senior Principal Pharmacometrics Scientist to lead pharmacometric methodologies for drug development projects. Responsibilities include driving strategic contributions to regulatory submissions and collaborating with internal teams. Ideal candidates will hold a Ph.D. and have experience in clinical drug development, fostering a collaborative team culture aimed at improving patient lives.

Qualifications

• Experience in pre-clinical and clinical drug development applying model-based methods.
• Clinical, pharmacological, and therapeutic knowledge of at least one disease area.
• Experience in shaping best practices in pharmacometrics.

Responsibilities

• Provide global strategic pharmacometrics leadership.
• Represent Global Project Teams, including regulatory interactions.
• Drive pharmacometrics contributions to regulatory/submission strategy.

Skills

Pharmacometric methodologies

Regulatory submissions support

Clinical drug development

Pharmacokinetic-Pharmacodynamic modeling

Education

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

Job description

-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 a Senior Principal Pharmacometrics Scientist you will be responsible for the discussion and implementation of pharmacometrics methodologies as well as providing pharmacometrics support for regulatory submissions and integrated evidence generation contributing to drug development and adoption decisions with internal and external partners.

Key Accountabilities:

• You will provide global strategic pharmacometrics leadership and support to clinical development programs of low to mid complexity, based on relevant technical and disease area knowledge.
• You will represent the Global Project Teams internally and externally, including in regulatory interactions.
• You will provide technical pharmacometrics expertise and identify opportunities for influencing internal discussions on white papers/regulatory policy.
• You will drive the pharmacometrics contributions to regulatory/submission strategy and related documents (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, responses to Health Authority questions) with oversights.
• You will assess pharmacometrics requirements insuring the integration of pharmacometrics information into transition of drug development milestones / decision boards.
• You will contribute to Integrated Evidence generation by leveraging disease progression and Pharmacokinetic-Pharmacodynamic modeling techniques using varied data sources, including Real World Data.
• You will align with the Analytics team (biometrician, data management, database programming, programming, medical and scientific writing) 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).
• Experience in pre-clinical and clinical drug development applying model-based methods.
• Clinical, pharmacological, and therapeutic knowledge of at least one disease area.
• Experience in shaping best practices in pharmacometrics contributing to external white papers/policy and developing/establishing pharmacometrics excellence.

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? : https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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? https://www.novartis.com/about/strategy/people-and-culture

Join 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: https://talentnetwork.novartis.com/network

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.