Hybrid Senior Director DMPK – Nonclinical Consulting

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About the role

  • Senior Director managing DMPK consultancy projects at ICON plc. Providing expertise in drug metabolism and pharmacokinetics for client regulatory submissions and business development.

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

  • Bachelor 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.
  • Ideally experience and a desire to take on a leadership role within the group.
  • Some domestic and international travel is required from time to time, so a valid Driver's license and Passport is required.

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Job title

Senior Director DMPK – Nonclinical Consulting

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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