Associate Director PBPK M&S

Job content

Job Description

750 million+. That’s the number of lives our products touch. While we’re proud of that fact, in this world of digital and technological transformation, we must continue to improve and extend even more people’s lives. We believe we can achieve the goal when curious, courageous and collaborative people like you are brought together in an inspiring environment, empowering you to take calculated risks, and teaming you with people who share your determination, to tackle the world’s toughest medical challenges.

The Modeling and Simulation group in PK Sciences (PKS) at Novartis is searching for an Associate Director in the Clinical PBPK (physiologically-based pharmacokinetics) group.

The candidate’s role will involve the development of PBPK models to understand the interrelationships of physico-chemical properties of the drug, the dosage form, and the route of administration on the rate and extent of systemic availability. This rational biopharmaceutics-based formulation design will impact clinical service form and final market image formulation selection and influence subsequent process changes during development. In addition, the candidate will integrate in vitro and in vivo data for drug-drug interaction and specific population (pediatric, organ impairment) pharmacokinetic predictions. The goal is to use modelling and simulation to achieve biowaivers, to set clinically relevant specifications, to predict food and other drug effects, to optimize clinical trial designs and to inform the need for them- ultimately, to get our medicines to patients faster.

What will you be doing?
In this role you will:

• Conduct of PBBM (physiologically-based biopharmaceutics modeling) and virtual bioequivalence PBPK to support formulation selection and biopredictivity for drug candidates from IND Stage through Phase IV across adult and pediatric populations.
• Develop and implement strategies to support the rational biopharmaceutics based formulation design for clinical service form and final market image formulation selection and subsequent process changes during development and for biopredictive dissolution testing. The goal is to achieve biowaivers, to set clinically relevant specifications, to predict food and pH effects.
• Provide matrix leadership to collaborate, align and influence across cross-functional teams to identify and mitigate key project issues related to biopharmaceutics, pharmacokinetics of specific populations (e.g. organ impairment, pediatrics, etc.), drug-drug interactions, in which PBPK or PBBM modeling can be leveraged.
• Integrate, interpret and report data to project teams and other customers. Author scientific documents within agreed timelines and which meet regulatory requirements as well as prepare appropriate responses to Health Authority questions (globally).
• Promote the use of innovative approaches within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings.
  

Minimum Requirements

• Ph.D. in pharmaceutical sciences or relevant discipline with experience in biopharmaceutics, pharmacokinetics, and modeling and simulation. At least 5-10 years in pharmaceutical industry including demonstrated knowledge and experienced with physiologically-based pharmacokinetic (PBPK) modeling.
• Hands on experience with PBPK modeling tools such as PK-Sim, Simcyp, or GastroPlus is required. In addition, experience with modeling software such as Monolix, R, Phoenix, or Nonmem is desired.
• Extensive and in-depth knowledge of pharmacokinetics including, absorption, distribution, metabolism, and excretion (ADME) science, experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences.
• Proactive, self- motivated and independent working style. Used to work in a global, multidisciplinary team and an ability to understand the needs and goals of the broader organization
• Ability to drive for results with a sense of urgency, courage and innovative thinking.
• Excited to work in a highly matrixed, highly supportive organization as a servant leader; enjoys being a mentor
  

WHY NOVARTIS?

769 million lives were touched by Novartis medicines in 2020, 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!

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network :If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Division
NIBR

Business Unit
Translational Medicine

Country
Switzerland

Work Location
Basel

Company/Legal Entity

Novartis Pharma AG

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Early Talent
No