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DMPK Director - Cambridge, United States - Fraser Dove International
Description
DMPK Project Lead (Director Level)Do you have experience leading projects from early development to early clinical development?
Do you have a proven track record in DMPK?
Do you have expertise with modelling and simulation?
Fraser Dove International is partnering exclusively with a global biopharmaceutical organisation. Operating worldwide, they are committed to transforming patients' lives by pushing the boundaries of what is possible.
Our client is seeking a leader to hold project responsibility for early discovery towards candidate selection and into the clinical phases of the development.
Discover more about our DMPK Project Lead opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
What you will do:
As the DMPK Project Lead, your duties and responsibilities will include:
Designing appropriate experimental studies and liaising with other areas of the R&D organization to deliver data and interpretations to support the project towards candidate selection and beyond.
Having an expert understanding of the different approaches related to preclinical pharmacokinetics, as well as a good understanding of related disciplines ( e.g., toxicokinetics, nonclinical safety, PKPD, PK modelling, drug design, clinical DMPK, bioanalytics and biomarkers).Applying their understanding of physical properties, DMPK and enzymology to input into the design of new compounds.
Working with the project and Development Sciences colleagues to resolve or risk-mitigate project-related ADME challenges.Working with other areas in the DMPK organization to champion new, innovative approaches to project support and ensure UCB stays at the forefront of DMPK science.
Preparing the DMPK sections of internal and regulatory documents (e.g. IND, IMPD, IB, NDA).Participating in research aligned to DMPK and UCB's portfolio to publish research papers in internationally recognized journals.Providing scientific mentorship to support junior staff in their personal development.
What you will bring:
These are the skills and experience you will need to succeed as the DMPK
Project Lead:
PhD, or equivalent, in Pharmaceutics, Pharmacology, Drug metabolism or Pharmacokinetics, with 7+ years of Post-Doctoral Industrial experience; or a related degree with 10+ years industrial experience in DMPK science.
Deep understanding of discovery and development DMPK including modelling and simulation and a proven ability to delineate the impact of chemical structure on measured properties.
Broad experience in pharmaceutical R&D including a knowledge of the regulatory requirements and experience working with regulatory agencies to fulfil the DMPK contribution to new drug submissions.
Demonstrated track record of experience in DMPK/ADME and excellent knowledge in ADME/Enzymology/Drug Transporters and knowledge of how to couple data to optimization/selection of NCE, both in discovery and development.
A demonstrable track record of leading, understanding and hands-on experience of drug metabolism and pharmacokinetics, both in vitro and in vivo studies, human PK prediction, DDI prediction and mechanistic understanding to support late-stage programs.
Knowledge of PKPD and preferably an understanding of PBPK modelling.Demonstrable skills for in depth mechanistic understanding of DMPK related issues and of the impact and value of translation to humans.
Understanding of the drug development processes in the Pharma Industry environment.Got what it takes?
To apply for the DMPK Project Lead, click the 'Apply' button below
Please Note:
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position.
Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.
We use the information in your application to support your job search, contact you with relevant opportunities and to improve our services.
For more information on how we process your personal data, please view our Privacy Policy available on our website:Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.
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