Senior Director DMPK - Nonclinical Consulting

Senior Director DMPK - Nonclinical Consulting

ICON

Reading, United Kingdom

We are currently seeking a Senior Director, with extensive expertise in Drug Metabolism and Pharmacokinetics (DMPK), to join our nonclinical consultancy team. As a Senior Director at ICON, you will work closely with other team members to provide expert scientific and strategic advice to our customers.

What you will be doing

• Providing expert knowledge of DMPK requirements on a variety of different projects, including small molecules and biopharmaceuticals, such as ADCs.
• Conducting in-depth review of nonclinical programmes to identify any gaps in the data package ahead of regulatory submission.
• Troubleshooting specific issues related to DMPK and strategising solutions.
• Preparing written sections of regulatory submission documents pertaining to DMPK, including IBs and eCTD Modules.
• Identification of appropriate nonclinical CROs and placement/monitoring of DMPK studies on behalf of ICON’s customers.
• Engaging and driving business development initiatives.

Your profile

• Batchelor of Science (BSc) or above with minimum of 20 years experience in pharmaceutical development, including at least 10 years’ experience working as a DMPK subject matter expert (SME), with in depth knowledge of in vitro and in vivo assays, bioanalytical techniques and pharmacokinetic interpretation/modelling.
• Proven track record of decision making, planning and organising.
• A sound understanding of current regulatory guidelines and expectations for nonclinical ADME requirements across all phases of clinical development.
• Excellent communication and interpersonal skills, with the ability to represent the nonclinical team effectively both internally and externally.
• Self-motivated and confident to work independently with minimal supervision, but also an excellent team player. Depending on experience, there may be the opportunity to advance into a leadership role.
• Some domestic and international travel is required from time to time, so a valid Driver's license and Passport is required.

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