Director of Business Information Technology at CGT, leading IT strategy and operations in manufacturing. Overseeing SAP functions, cyber security strategy, and IT team management.
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
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