Principal Scientist, PK Sciences Oncology

Aug 10, 2021

Job Description

450 projects straddling discovery through development in PK Sciences (PKS) for you to represent the clinical pharmacology and PK/PD/ADME disciplines on discovery and development project teams. As a project team member, you will suggest and implement strategies and tactics to advance high-quality entities as part of the overall program(s).

PK Sciences (PKS) is a global organization of about 300 associates, situated within Translational Medicine (TM), the clinical research arm of NIBR. 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 organization, working across both NIBR and the Global Drug Development (GDD) organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology from discovery through approval and beyond.

In the role of Principal Scientist, PKS Oncology, you will develop and implement clinical pharmacology strategies to support small and large molecule drug development from early discovery through late clinical development. This unique role will provide matrix leadership to collaborate, align and influence across the cross-functional team to identify and mitigate key project issues related to the pharmacokinetic sciences discipline (clinical pharmacology and PK, PK/PD, metabolism).

In addition, you will be responsible for the 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 and NDA/BLAs to meet regulatory requirements as well as prepare appropriate responses to Health Authority questions across the globe. You will have the opportunity to oversee or perform PK and PK/PD analyses using a variety of tools and approaches and integrate, interpret and report data to project teams and other customers.

Diversity & 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.

Minimum Requirements

What you will bring to this role:

• Ph.D./Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related biologic background.
• A minimum of 2 years of experience in drug discovery and/or development in a relevant (academia, CRO, biotech or Pharma) environment in a lead role overseeing clinical pharmacology strategy of compound 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.
• Hands-on project experience with low molecular weight as well as biologics modalities.
• Demonstrate success in working in a cross-functional, matrixed, project-team environment.
• Strong oral and written communication skills.

Position will be filled at level commensurate with experience
Translational Medicine
Cambridge, MA
Research & Development
Full Time
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Principal Scientist, PK Sciences Oncology

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