Job ID: REQ-10006554
Date: May 20, 2024
Location: USA
Summary
Principal Scientist/Sr. Principal Scientist PK Sciences - Oncology
About the role:
The position is located in Cambridge, MA and will not have the ability to be located remotely.
We are seeking an enthusiastic and motivated PK Sciences project team representative to develop and implement DMPK and/or clinical pharmacology strategies to support the pursuit of transformative new medicines from early discovery through late clinical development. Our unique organizational structure enables colleagues to work seamlessly in the discovery and/or clinical space, offering opportunities for development and bench-to-bedside-to-bench translation. Equally, deep expertise in either discovery or clinical areas are valued. The scope of the role potentially includes small molecules, biologics/therapeutic proteins, antibody drug-conjugates, radioligand therapies and/or cell therapies.
Key Responsibilities
- Represent the PK Sciences function in project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriate.
- Develop the PK strategy for lead optimization and oversee the execution of nonclinical studies to identify compounds with favorable DMPK properties.
- Work with teams to elucidate the understanding of PK/PD relationships and develop dosing strategies and predictions.
- Develop and execute clinical pharmacology strategies, including input into nonclinical and clinical study design, and analyzing PK and PK/PD data, to support compound development from discovery through late development.
- PK, dosimetry (radiopharmaceuticals), PK/PD and M&S component of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections/radiation dosimetry of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses to Health Authority questions across the globe.
This role reports to a PK Sciences (PKS) Oncology group lead/unit head within Translational Medicine (TM) in Biomedical Research. PKS is a global organization of about 300 associates, situated within Translational Medicine (TM), the clinical research arm of Biomedical Research within Novartis. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, bridging drug discovery and clinical application.
Minimum Requirements
- Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background.
- A minimum of 2 years of experience in drug discovery and/or development in a relevant environment (academia, CRO, biotech or Pharma).
- 4 plus years of experience required to be considered for Senior Principal Scientist level including 2 plus years of experience in a lead role overseeing ADME/DMPK project strategy, either in discovery or clinical development.
- Extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation, experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences.
- Demonstrated success in working in a cross-functional, matrixed, project-team environment.
- Strong oral and written communication skills.
- Hands-on project experience with drug conjugates and/or radiopharmaceuticals is a plus.