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7 Dec 2020

Full-Time Senior Clinical Pharmacology Lead

UCB Bioscience – Posted by UCBdenise Cambridge, Massachusetts, United States

Job Description

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

 

 

 

 

We are currently seeking a Senior Clinical Pharmacology Lead to head the development and execution of clinical pharmacology plans that characterize the pharmacokinetic (PK) and pharmacodynamics (PD) properties and drug-exposure relationships of therapeutic molecules. By integrating PK, PD, pharmacogenetic, demographic and disease knowledge, the individual will be critical in leading the strategy and implementation for optimizing and driving insightful drug development plans in support of UCB-Ra Pharma novel small molecule and peptide therapies.

Primary responsibilities will include leadership of program-specific clinical pharmacology strategies, analysis and interpretation of PK/PD data, and modeling and simulation in support of a rapidly growing portfolio. The individual will lead and influence globally, being part of the global Quantitative Pharmacology and DMPK and Quantitative Clinical Pharmacology Leadership Teams. Candidates should be self-motivated with experience working and leading in a highly collaborative cross-functional environment.

 

You like to work in an environment where you can:

  • Lead Clinical Pharmacology to support the development of novel therapeutic agents from early phase to late phase, regulatory submission, and beyond via characterizing PK and integrating knowledge in PK/PD/efficacy/safety to select the right dose and dose regimen for the general population and subpopulations.
  • Provide expertise and know-how in designing and implementing clinical pharmacology strategy in clinical trials during all clinical phases
  • Interact with regulatory authorities with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to clinical pharmacology and drug development

 

You will contribute by:

  • Address and resolve scientific issues arising in drug discovery/development programs
  • Opportunity to develop as a Development Science matrix leader, driving the overall integrated strategy for (QCP, Bioanalytics, non-clinical safety, DMPK and pharmacometrics) at the development team for assigned projects
  • Expected to mentor and supervise other staff locally or globally

 

Minimum Qualifications

  • Ph.D., PharmD, or M.D. in pharmacokinetics, biopharmaceutics, pharmacology, or a related discipline and a minimum of 10 years of industry experience.
  • Extensive knowledge of the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation and reporting is a prerequisite.
  • The successful applicant should have experience in providing input on clinical pharmacology plans and the preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
  • Hands-on experience with modeling and application of quantitative clinical pharmacology including pharmacometrics and other model-based approaches to guide drug development is required

Preferred Qualifications

  • Experience working on the development of small molecules, biologics and ideally gene therapies is highly desirable.
  • Able to solve technical problems with enthusiasm in a global team environment
  • Good written and oral communication skills
  • Ability to thrive and develop in a biotechnology culture

 

 

About Us

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient’s needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

How to Apply

https://careers.ucb.com/job/Cambridge-Senior-Clinical-Pharmacology-Lead-Mass/623074601/?locale=en_US

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: Not Disclosed.

Job expires in 50 days.

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