Translational PK Scientist I

Novartis; Cambridge (MA); On-site; USD 109,000 - 222,000; Full time

Job summary

Novartis in Cambridge, MA, seeks an enthusiastic PK Sciences project team representative to develop and implement translational or clinical pharmacology strategies across late clinical development, spanning small molecules, biologics, and cell therapies.

You will lead PK/PD understanding, design studies, author PK sections of regulatory documents, and collaborate with ADME, Modeling & Simulation, and clinical teams to integrate PK insights into project plans.

Qualifications

• Ph.D. / Pharm.D. required with relevant clinical pharmacology experience.
• Extensive knowledge of PK/PD, drug metabolism, and regulatory sciences is preferred.
• Experience in cross-functional, matrixed project teams and communication skills are essential.

Responsibilities

• Represent PK Sciences in project teams and regulatory interactions.
• Develop and execute clinical pharmacology strategies from discovery through late development.
• Elucidate PK/PD relationships and develop dosing strategies.
• Author PK/clinical pharmacology sections of regulatory documents (IND/IMPDs, NDAs/BLAs).
• Collaborate with ADME, BA/PK, Modeling & Simulation, and clinical teams to integrate PK insights.
• Utilize AI/ML approaches to enhance model-guided design and data automation.

Skills

Pharmacokinetics

Drug metabolism

Clinical pharmacology

Regulatory science

Cross-functional teamwork

AI/ML familiarity

Education

Ph.D. or Pharm.D.

Job description

Novartis in Cambridge, MA, seeks an enthusiastic PK Sciences project team representative to develop and implement translational or clinical pharmacology strategies across late clinical development, spanning small molecules, biologics, and cell therapies.

You will lead PK/PD understanding, design studies, author PK sections of regulatory documents, and collaborate with ADME, Modeling & Simulation, and clinical teams to integrate PK insights into project plans.