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.
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