Novartis Group Companies
Principal Scientist/Sr. Principal Scientist PK Sciences - DAx DARe TA
Novartis Group Companies, Cambridge, Massachusetts, us, 02140
Job Description SummaryAbout 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.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.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.Benefits and Rewards:Read our handbook to learn about all the ways we'll help you thrive personally and professionally: Novartis Life HandbookCommitment 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.EEO Statement: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.Accessibility and reasonable accommodations:The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information.Salary Range:$130,400.00 - $195,600.00Skills Desired:Chemistry, Clinical Pharmacology, Clinical Research, Drug Discovery, Initiative, Medical Research, Patient Care, Physiology, Quality Control, R&D (Research And Development), Simulation Software, Translational Medicine
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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.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.Benefits and Rewards:Read our handbook to learn about all the ways we'll help you thrive personally and professionally: Novartis Life HandbookCommitment 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.EEO Statement: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.Accessibility and reasonable accommodations:The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information.Salary Range:$130,400.00 - $195,600.00Skills Desired:Chemistry, Clinical Pharmacology, Clinical Research, Drug Discovery, Initiative, Medical Research, Patient Care, Physiology, Quality Control, R&D (Research And Development), Simulation Software, Translational Medicine
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