Manager, DMPK and PK/PD Modelling
Meet Recruitment
Lille
Full-time
Manager, DMPK and PK/PD Modelling – Global Pharma – Hybrid – Lille
Incredibly excited to be collaborating with our new client, a Global Biopharmaceutical, to support their search for a new Manager of DMPK and PK/PK Modelling to join their team in Lille, France.
The Client
Our client is a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases characterized by high unmet medical needs and is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades. Its capacity to develop high potential assets, from early-stages to late development and pre-commercialization stages, is illustrated through the successful 52-week readout of its Phase 3 trial (ELATIVE®) evaluating elafibranor in Primary Biliary Cholangitis (PBC).
They have a diversified R&D pipeline covering several therapeutic areas: five programs in acute on chronic liver failure (ACLF) are in clinical stages (Phase 2) and pre-clinical stages, including hepatic encephalopathy (HE), one of the main complications of ACLF; a Phase 2 clinical program targeting cholangiocarcinoma; and a preclinical program targeting urea cycle disorders (UCD) and organic acidemias (OA). The pipeline also includes a diagnostic franchise focused on Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis or NASH) and ammonia.
The Role
As Manager, DMPK and PK/PD Modelling, you will lead the Drug Metabolism and Pharmacokinetics (DMPK) activities. In this role you will have the opportunity to develop scientific strategies, leveraging your knowledge in ADME concepts, pharmacokinetics (PK), pharmacodynamics (PD), PK/PD modeling and bioanalytical principles to further advance the non-clinical and clinical development stage programs. Together with your team, you will drive the quality and performance of all DMPK activities. You will work cross-functionally with translational and clinical research to meet regulatory requirements as molecules in early development progress to later phases of clinical trials.
MISSIONS:
Your responsibilities include, but are not limited to:
- Design and lead the execution of Drug Metabolism and Pharmacokinetic (DMPK) studies to evaluate the ADME and Pharmacokinetic (PK) properties supporting the progression of drug candidates into the clinical phase;
- Oversee the analysis, interpretation, and reporting of DMPK studies (including Drug-Drug Interactions) throughout preclinical and clinical drug development;
- Conduct hands-on PK and PK/PD analysis based on compartmental, non-compartmental and population PK approaches using non-clinical and clinical data;
- Use modelling and simulation to predict human exposure/efficacious dose that will inform decision making for formulation design/optimization, First in Human dose selection, target patient population, disease state, Drug-Drug Interaction (DDI) predictions and clinical study designs, and regulatory strategy;
- Manage bioanalytical teams to implement and validate bioanalytical methods, to manage sample analysis and interpret data, and to develop data transfer plans;
- Work closely with other departments, such as research, toxicology and clinical, regulatory to ensure a coordinated approach to drug development;
- Contribute to the preparation of regulatory documents including Investigator’s Brochure, INDs, CTAs, and NDA filings;
- Manage internal and external collaborations and resources including interactions with CROs and internal projects stakeholders;
- Ensure compliance with industry regulations and standards in all DMPK activities;
- Define and assign resources and budget to all DMPK projects;
- Initiate and lead collaborations with academic sites and participate in the preparation of abstracts and manuscripts for publication.
This a truly unique role with a strong focus on PK/PD Modelling, a strong background in this area is a must.
If you feel like making a change into a diverse and innovative organisation where you can make a significant individual impact to their current and future success as well being pivotal in the commercialisation of life changing medicines, please do not hesitate to get in touch!!
Brendan Mulvaney
+44 203 019 3985
[email protected]