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Principal Scientist, Quantitative Clinical Pharmacology

3 months ago

Cambridge, United States UCB Full time

 

Make your mark for patients

 


 

POSITION DESCRIPTION

Our new Principal Scientist â Quantitative Clinical Pharmacology / PK-PD Lead will focus on quantitative clinical pharmacology activities in selected diseases/therapeutic areas and assigned project(s) to drive further Early and Late Clinical Development within UCB, working with other functional experts to create a clinical development plan. 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 through life-cycle management, driving dose and regimen selection, 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. In particular, he/she will ensure high quality input to Project Lifecycle 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.  Note: This position will be based out of UCBâs Boston R&D Hub located in Cambridge, MA.

 

MAJOR ACCOUNTABILITIES

  • Act as a QCP/PK-PD lead on assigned Clinical Team and program/project teams, delivering 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 analysis, interpretation and reporting of human pharmacology results and PK-PD results from non-human pharmacology studies. Developing/managing clinical pharmacology/M&S -related aspects of clinical trial/program budgets
  • Participate in implementing Model Based Drug Development using quantitative approaches to address complex questions arising during drug development. In particular, integrating PK-PD knowledge on an ongoing project basis. Accountable and responsible for assigned protocol synopsis and study report content.
  • As appropriate, being DevSci lead for the assigned project.
  • Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD data are generated and analyzed including population PK, PK-PD modeling and simulation, meta-analysis etc, to support the project progression.
  • 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, contributing to the writing and reviewing responses to regulatory queries.
  • 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

                                                                                    

REQUIRED EDUCATION & EXPERIENCE

  • M.D. and/or Ph.D. in relevant area of science
  • Candidates should have some experience of participating in the development of a 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).
  • A strong understanding of pharmacodynamic and translational methods, experimental medicine tools, regulatory requirements, PK/PD, DMPK, population pharmacokinetic-pharmacodynamic modelling and simulation

 

TECHNICAL CAPABILITIES

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

  • Knowledge of Clinical Pharmacology and the application of Modeling & Simulation
  • Able to understand clinical effects, pharmacological, physiological and biochemical understanding
  • 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 managing/delivering PK/PD modeling activities
  • Experience in managing/delivering PBPK, population PK and IVIVE
  • Understanding of mechanism-based drug interactions/In vivo/in vitro models
  • General knowledge of Biopharmaceutics/Biostatistics/Pharmacogenomics
  • Sufficient Knowledge of phases of Drug development  

 

Other critical Capabilities/Skills:

  • Able to communicate quantitative clinical pharmacology PK/PD core activities at a Clinical Team and sub-team level in a manner that promotes productive relationships.
  • Ability effectively contribute to interdisciplinary team meetings and, when applicable leading sub-teams motivating others in matrix/departmental environment.
  • 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 expertise recognized internally and externally

 

 

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.

 

RANDATUCB


 

Are you ready to âgo beyondâ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you 

 

About us 
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. 

 

Why work with us? 
At UCB, we donât just complete tasks, we create value. We arenât afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We âgo beyondâ to create value for our patients, and always with a human focus, whether thatâs on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. 

 

As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 
 
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.