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Senior Director DMPK - Nonclinical Consulting

ICON plc

Posted 10 hours ago

Employment Type

Full Time

Location

Completely Remote

Requirements

BSc or above, 20+ years experience, 10+ years DMPK SME, Regulatory knowledge, Communication skills, Travel requirements

Required Skills

DMPK Nonclinical Consulting Regulatory Compliance

Job Description

Responsibilities

  • 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.

Requirements

  • 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)
  • Proven track record of decision making, planning and organising
  • Sound understanding of current regulatory guidelines and expectations for nonclinical ADME requirements across all phases of clinical development
  • Excellent communication and interpersonal skills
  • Self-motivated and confident to work independently with minimal supervision
  • Valid Driver's license and Passport required for travel

Benefits

  • Various annual leave entitlements
  • Health insurance offerings
  • Competitive retirement planning
  • Global Employee Assistance Programme
  • Life assurance
  • Flexible country-specific optional benefits

About the Company

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

How to Apply

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