Apr 15, 2022

Job Description

PK Sciences (PKS) offers you this opportunity to make an impact, where 450 projects are straddling discovery through development. PKS is a global organization of about 300 associates, situated within Translational Medicine (TM), in Novartis Institutes of Biomedical Research (NIBR). It is an enterprise organization, unique within pharmaceutical industry, where one can work across both NIBR (Research) and the Global Drug Development (GDD) organizations to apply the scientific knowledge of pharmacokinetics, pharmacodynamics, metabolism and clinical pharmacology in advancing the drug candidates from discovery and clinical development through approval and beyond. Novartis portfolio consists of projects using several therapeutic modalities including small molecules, biologics, gene therapy and cell-based therapies. We are active in multiple therapy areas like Oncology, Autoimmune Diseases, Neuroscience, Musculoskeletal Diseases, Ophthalmology, Respiratory, Cardio-metabolic and Infectious diseases. We collaborate across scientific and organizational boundaries, with a focus on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.

In the role of Associate Director/Director PK/PD, you will collaborate with business partners in a cross-functional team to select and characterize new chemical entities, large molecules and cell/gene therapies from research and advance promising entities into the clinic. This unique role will provide matrix leadership to collaborate, align and influence across the cross-functional teams of medical experts, study leaders, pharmacokineticists, statisticians, pharmacometricians and outsourcing experts to identify and mitigate key project issues across therapy areas and implement strategies related to the pharmacokinetic sciences [PKS] discipline (PK, PK/PD, metabolism and clinical pharmacology).

Your major accountabilities will include:
• Representing the PK/PD/ADME and Clinical Pharmacology discipline, and serving as the primary source of scientific expertise on global cross-functional project teams, leading the design, execution and analysis of PKS preclinical and clinical studies, with focus on moving candidates from the discovery phase to clinics.
• Working with subject matter experts in PKS and partner groups, supporting the efficient application and integration of modeling and simulation tools to advance lead optimization and clinical candidate selection.
• Making use of PKS resources across NIBR organizations to drive project efforts; ensuring an aligned position on research strategy and in particular human PK/PD and dose projections as candidates transition into the clinic.
• Supporting PKS components of preclinical and clinical study protocol designs, preclinical and clinical study reports and investigator brochures, regulatory submission documents, etc.
• Preparing for Health Authority calls/meetings/discussions and acting as responsible PKS representative in these settings.
• Collaborating with other NIBR and GDD functions, bringing innovative ideas and approaches, and a leadership, enterprise mindset that informs and influences the overall drug discovery and development process.
• Representing PK Sciences as a discipline expert (Assoc. Dir.) or senior discipline expert (Director) to internal and external scientific communities.
• Authoring of key position papers or presentations to internal and external scientific meetings, consortia, regulatory agencies as appropriate (senior expert authoring at Director level).

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 the role:

Minimum requirements:
• PhD, PharmD or MD in pharmacology/physiology, biochemistry, chemistry, pharmacokinetics/pharmaceutical sciences, or related sciences
• Extensive and in-depth knowledge of the drug discovery and/or development process, with a minimum of 5 years’ (Assoc. Director) or 10 years’ (Director) industry experience in a drug discovery and/or development setting,
• Demonstrated success of working in a global matrix environment and with cross functional project teams
• Extensive and in-depth knowledge of pharmacokinetics, clinical pharmacology 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
• Familiarity with standard ADME/PK modelling tools such as Phoenix, GastroPlus, etc.
• Experience in authoring regulatory documents with knowledge of global regulatory requirements and guidance is advantageous
• Hands-on project experience with low molecular weight and biologics modalities
• Experience in authoring regulatory documents with knowledge of global regulatory requirements and guidances is advantageous
• Strong coaching, mentoring or people management skills are desired
• Ability to evaluate in-licensing opportunities and carry out Due Diligence activities as required.
• Excellent written and oral (English) communication and negotiation skills

Desirable skills:
• Hands-on project experience with cell-based and/or gene-based therapies is highly desirable
• Hands-on project experience with ophthalmic therapies is highly desirable

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

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Translational Medicine
Cambridge, MA
Research & Development
Full Time
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Associate Director/Director PK Sciences Ophthalmology

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