Clinical Pharmacology Director - Home-Based (US)

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.

• Provide clinical pharmacology support for programs through the worldwide marketing application filing, including supportive registration documents and presentations.
• Review and prepare documents for regulatory submission, including clinical development plans, Investigator’s Brochure, and the Clinical Pharmacology section of INDs, CTAs, and/or NDAs.
• Contribute to the clinical pharmacology sections of regulatory documents, including Investigator Brochures, documents for regulatory meetings, NDA/BLA/MAA.
• Participate in designing the overall clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the Company.
• Write and review scientific documents, such as Clinical Study Protocols, Standard Operating Procedures (SOPs), Statistical Analysis Plans, and Clinical Study Reports
• Collaborate with cross-functional teams, including clinical, clinical operations, regulatory affairs, and biostatistics, to ensure the successful execution of clinical trials
• Ensure the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology.
• Development and execution of clinical pharmacology strategies for late-stage development programs from Proof-of-Concept (Phase 2a) through worldwide marketing application.
• Oversee population PK, ER, c-QTc analyses conducted by the vendors and perform PK NCA analysis/fit-for-purpose PK/PD simulation if needed.
• Provide expert PK/PD advice to cross-function project teams.

• Advanced degree (PhD, PharmD, MSc) in Pharmacology, Pharmaceutical Sciences, or related field.
• Minimum of 5 years of experience in clinical pharmacology in the pharmaceutical industry.
• Strong knowledge of PK/PD principles and their application to clinical pharmacology.
• Familiarity with PK/PD software (e.g. WinNonlin, NONMEM, Monolix, R, etc) and working knowledge of MIDD concepts.
• Experience in oncology small molecule development is preferred.
• Experience in regulatory submissions and interactions with regulatory agencies.
• Experience in clinical pharmacology study design and interpretation.
• Experience in clinical pharmacology data analysis and reporting.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.