Associate Director/Director PK Sciences – Oncology

SummaryThe position is located in Cambridge, MA and requires the ability to be on site for team meetings and department interactions.About The RoleWe 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.Minimum RequirementsPh.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background.A minimum of 5 years of experience in drug discovery and/or development in a relevant environment (academia, CRO, biotech or Pharma).A minimum of 8 plus years of experience required to be considered for Director level including 5 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.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 InclusionNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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