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28 Oct 2020

Full-Time Clinical Pharmacology Lead

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

Job Description

Ra Pharmaceuticals, now part of UCB, is a clinical-stage biopharmaceutical company based in Cambridge MA focused on the discovery, development and commercialization of novel therapeutics based on its proprietary peptide chemistry platform. Ra is developing therapeutics to treat serious diseases that are caused by excessive or uncontrolled activation of the complement system, a critical component of the immune system. Ra Pharmaceuticals is assembling a team of highly motivated and experienced professionals who are committed to improving the lives of patients and building a world class biotechnology company.

 

We are currently seeking a Clinical Pharmacology Lead to support the development and execution of clinical pharmacology plans that characterize the pharmacokinetic (PK) and pharmacodynamics (PD) properties and drug-exposure relationships of candidate molecules. By integrating PK, PD, pharmacogentic, demographic and disease knowledge, the individual will be critical in optimizing and driving insightful drug development plans in support of UCB/Ra’s novel small molecule and peptide therapies.

 

You like to work in an environment where you can:

  • Develop program-specific clinical pharmacology strategy, analysis and interpretation of PK/PD data, and modeling and simulation in support of a rapidly growing portfolio.
  • 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.
  • Interact with regulatory authorities with in-depth knowledge on subject matter area, regulatory requirements and guidelines related to clinical pharmacology and drug development
  • Utilize your self-motivation and professional experience in a highly collaborative cross-functional environment.

You will contribute by:

  • Provide expertise and know-how in designing and implementing clinical pharmacology strategy in clinical trials during all clinical phases
  • Proactively address and resolve scientific issues arising in drug discovery/development programs.

Interested? For this position you’ll need the following education, experience and skills:

Minimum Qualifications:

  • Ph.D., PharmD, or M.D. in pharmacokinetics, biopharmaceutics, pharmacology, or a related discipline and a minimum of 5-7 years of industry experience.
  • The successful applicant must 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.
  • Extensive knowledge of the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation and reporting is a prerequisite.

 

Preferred Qualifications:

  • Must be a flexible and detailed-oriented eager to work in a collaborative environment

 

 

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-Clinical-Pharmacology-Lead-Mass/614507301/?locale=en_US

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

Job expires in 60 days.

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