Band
Level 5
Job Description Summary
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 Tcell therapies including CART cell modalities and Tcell 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:
Your responsibilities include but are not limited to:
Independently represents PK Sciences as a core member of discovery translational and global project teams and leads a PKS subteam 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.
Job Description
What youll bring to the role:
Ability to work in and adopt to a changing scientific & regulatory environment
A strong team player demonstrating excellent communication skills and with experience in leading crossfunctional 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 indepth expertise in clinical pharmacology with significant 5 years) drug development experience with the focus on biological drug candidates (all modalities)
Uptodate background on stateoftheart scientific and regulatory aspects of biologics drug development
Experience with standard PK analysis software (Phoenix) and understanding of applications of M&S techniques
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