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Lead Scientist

2 months ago

Cambridge, Massachusetts, United States Novartis Farmacutica Full time
About the Role

We are seeking a highly skilled and experienced Senior Research Scientist to join our team at Novartis Farmacutica. As a key member of our Pharmacokinetics and Pharmacodynamics team, you will be responsible for developing and implementing discovery DMPK and/or translational strategies to support the pursuit of transformative new medicines from early discovery through early clinical development.

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 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.

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.

What We Offer:

  • A competitive salary and benefits package.
  • The opportunity to work with a talented team of scientists and professionals.
  • The chance to contribute to the development of innovative new medicines.
  • A dynamic and supportive work environment.