Associate Director/ Senior Principle Scientist in PK Science

50+ projects are being supported in the Immunology Therapeutic Area within the PK Sciences department. We provide PK and PK/PD strategies from early discovery all the way through to registration and beyond. More than half of this portfolio represents biologics projects spanning from classical monoclonal antibodies to complex biologics constructs and extending to T-cell therapies, including CAR-T cell modalities and T-cell engagers. Since our portfolio is growing, our Team likes to expand by adding an experienced Team member who will drive our biologics projects.

Your Responsibilities:

• Independently represents PK Sciences as a core member of discovery, translational and global project teams and leads a PKS sub-team to define PKS strategy for compound progression and development.
• Analyze and interpret PK/PD/IG data generated during discovery, early and full development; present results to the program.
• Proactively identifies potential project hurdles, provides solutions and contributes to contingency plans.
• Independently authors and contributes to key clinical and regulatory documents including, but not limited to: clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND / IMPDs and NDAs within agreed timelines, and meeting all regulatory requirements.
• Publishes internally or externally as main contributor to enhance Novartis and PK Sciences visibility.

Please note this is a hybrid role - there is a requirement of a minimum of three days on site in the London office per week or twelve days a month. We are unable to offer permit sponsorship for this role.

What you’ll bring to the role:

• Ability to work in and adapt to a changing scientific & regulatory environment.
• A strong team player, demonstrating excellent communication skills and with experience in leading cross-functional teams.
• A curious mind and a genuine interest in collaborative interactions across disciplines.
• PhD, MD or PharmD in life sciences/healthcare with a focus on biologics therapies.
• Credible background and in-depth expertise in clinical pharmacology with significant (5+ years) drug development experience focused on biological drug candidates (all modalities).
• Up-to-date background on state-of-the-art scientific and regulatory aspects of biologics drug development.
• Experience with standard PK analysis software (Phoenix) and understanding of applications of M&S techniques.

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!

Skills Desired: Chemistry, Clinical Pharmacology, Clinical Research, Clinical Study Reports, Clinical Trials, Data Entry, Drug Discovery, Due Diligence, Electronic Components, Gene Therapy, Lifesciences, Medical Research, Microsoft Office, Modeling And Simulation, Patient Care, Physics, Translational Medicine, Waterfall Model.