Senior Principal Scientist/Associate Director - Oncology PKS

Job Description Summary

The position is located in Cambridge, MA or East Hanover, NJ and requires the ability to be on site for team meetings and department interactions.

About the role:

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, translational phase or clinical areas are valued. The scope of the role potentially includes small molecules, biologics/therapeutic proteins, radioligand therapies.

Job Description

Key responsibilities:

1. Represent the PK Sciences function in project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriate.
2. Develop the PK translational strategy and provide expertise to the design of First in Human studies, oversee execution of the clinical study to characterize PK and PKPD properties.
3. Work with teams to elucidate the understanding of PK/PD relationships and develop dosing strategies and predictions.
4. 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.
5. Oversee the 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. PK Science is an enterprise-wide organization, working across both Biomedical Research and the Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology. Particularly, in radioligand therapies, Novartis has become the industry leader and is now developing a wide range of targeted radioligand therapies, and precision radioligand imaging agents, targeting multiple tumor types through a phenotypic precision medicine approach.

Essential requirements:

1. Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background.
2. A minimum of 10 years of experience in pharmaceutical industry or relevant environment (e.g. academia, biotech or CRO) in a field related to PK and/or clinical pharmacology (e.g. Drug Metabolism and Pharmacokinetics).
3. A minimum of 10 plus years of experience required to be considered for Associate Director level including 5 plus years of experience in a lead role overseeing ADME/DMPK project strategy, either in discovery, translational phase or clinical development.
4. 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.
5. Demonstrated success in working in a cross-functional, matrixed, project-team environment.
6. Strong oral and written communication skills.

Preferred requirements:

1. Experience with Radiopharmaceuticals.
2. Experience with translational or/and clinical development.

This is a dual level posting. The final level and title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered.

Commitment to Diversity and Inclusion / EEO: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.