Quantitative Clinical Pharmacology/PK-PD Lead

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Date: Jul 10, 2019

Location: Slough, GB

At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting with patients and their families around the world living with the physical and social burdens of severe disease of the immune system and the central nervous system. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help to transform lives.

 

Help us transform patients’ lives.

At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

To strengthen our Global Exploratory Department, based in our Slough hub in Slough, United Kingdom, we are looking to fill the position of: Quantitative Clinical Pharmacology/PK-PD Lead.

 

Role overview

In collaboration with other disciplines, he/she will be accountable and responsible for leading and driving, for the assigned project(s), an integrated PK-PD strategy (safety and efficacy) from clinical candidate selection (pre-FIH) to proof of concept, driving translational PK-PD knowledge to support the quantitative clinical pharmacology plans including go-no-go decisions, dose/regimen rationale.

Specific aspects include translational PK-PD understanding and modeling, effective integration and use of in silico, in vitro and in vivo preclinical data with mechanism-based models to anticipate the effects of new drugs in humans and transitional components.  Development of clear quantitative go-no-go decisions as the molecule passes through key stages of development. 

 

In particular, he/she will ensure high quality input to project teams as well as safeguarding that the quantitative clinical pharmacology component of the assigned global clinical development programs/projects are of high quality, meet regulatory standards and are delivered according to agreed timings.

 

Main accountabilities

  • Act as a QCP/PK-PD lead on assigned program/project and clinical teams ensuring a clear Quantitative Clinical Pharmacology Strategic planning. In particular, ensure that clear strategic QCP/PK-PD direction and input is provided to study level plans, designs, dose selections, PK/PD measures, strategy, and where appropriate operational expertise.  Responsible for design, analysis, interpretation and reporting of human pharmacology and PK-PD results.  
  • Drives, along with statistical colleagues the implementation of Model Based Drug Development (MBDD) using quantitative approaches to address complex questions arising during drug development. In particular, integrating PK-PD knowledge on an ongoing project basis, from pre-FIH and evaluating outcomes with competitor data through approaches such as meta-analyses. Accountable and responsible for assigned protocol synopsis and study report content.
  • Providing recommendations for clinical doses and dosing algorithms to the clinical and Development teams and, for the project of competence, leading the quantitative clinical pharmacology contributions to all regulatory documents, leads and contributes to the writing and reviewing responses to regulatory queries.
  • May provide quantitative clinical pharmacology/pk-pd expertise to discovery and due diligence activities
  • Expanding and maintaining key networks of external thought/opinion/academic leaders, as well as alliances with partners from the pharmaceutical industry, ensuring publication of key clinical pharmacology studies in international, peer reviewed journals, and presentations at international scientific meetings of relevance.

 

Essential Requirements

The candidates should have demonstrated experience (through examples) of participating and contributing to the development and execution of the clinical plan, with specific input and expertise in the clinical pharmacology components, including regulatory aspects (e.g briefing documents, MHRA meetings, pediatric plans, INDs, regulatory responses for labelling activities), and is able to attend regulatory meetings representing function and UCB with minimal coaching.  A strong understanding of pharmacodynamic and translational methods, experimental medicine tools, regulatory requirements, PK/PD, DMPK, population pharmacokinetic-pharmacodynamic modelling and simulation.

Education: Ideally Pharm D or PhD (or equivalent) with either relevant academic or industrial experience

 

Technical Capabilities

Essential clinical scientific skills, aligning UCB to the current edge in the field, including:

  • Knowledge of Quantitative Clinical Pharmacology and the application of Modeling & Simulation
  • Has a solid understanding of pharmacacological, physiological and biochemical effects of drugs (biologics, proteins and small molecules)
  • Knowledge of basic pharmacology in vivo/in vitro models  
  • Able to understand/Interpret safety/pharmacology/toxicology data                            
  • Experience in the assigned therapeutic area and with surrogate marker identification and application     
  • Experience in design, analysis and delivery of PBPK, PK/PD studies and modeling activities
  • Understanding of mechanism-based drug interactions/In vivo/in vitro models
  • General knowledge of Biopharmaceutics/Biostatistics/Pharmacogenomics

Other critical capabilities/skills

  • Able to communicate quantitative clinical pharmacology PK/PD core activities at a project and clinical team level in a manner that promotes productive relationships.
  • Ability effectively contribute to interdisciplinary team meetings and, able to effectively leading sub-teams (e.g. QCP) motivating others in matrix/departmental environment.
  • Able to represent function and UCB at regulatory meetings
  • Understand drug development bridging strategies
  • Ability to anticipate program needs and problem-solve, sharing critical data within the team and the line and proactively proposing solutions,
  • Working in a matrix team based environment being the initiator of the assigned part of development plans and studies
  • Scientific expertize recognized internally and externally


Job Segment: Biochemistry, Clinic, Toxicology, Physiology, Quantitative Analyst, Science, Healthcare, Data

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