Principal Scientist/Sr. Principal Scientist PK Sciences – DAx DARe TA

Job Description Summary

#LI-Hybrid

About the role:

The position is located in Cambridge, MA and will not have the ability to be located remotely.

This role reports to a PK Sciences (PKS) Dax (renal and liver diseases) and DARe (diseases of aging and regenerative medicine) therapeutic areas 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.

We are seeking an enthusiastic and motivated PK Sciences project team representative to develop and implement discovery DMPK and/or translational strategies to support the pursuit of transformative new medicines from early discovery through early 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.

 

Job Description

Major accountabilities:

• Represent the PK Sciences function in project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriate.
• Develop the ADME/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 early clinical development strategies, including input into nonclinical and clinical study design, and analyzing PK and PK/PD data, to support compound development from discovery through development.
• PK, PK/PD and M&S component of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections of IND/IMPDs as well as prepare appropriate responses to Health Authority questions across the globe.

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, in discovery and early 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.

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Benefits and Rewards:

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Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $130,400 – 195,600/year for Principal Scientist II and  $136,800 – 205,200/year for Senior Principal Scientist; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this positi