Clinical Pharmacologist

Clinical Pharmacologist

Location: Multiple US Locations Reference: JR163685 Categories: Medical & Scientific Affairs ICON Strategic Solutions (FSP) Remote

About the role

Clinical Pharmacologist

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

The CP is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, CPMP, etc.), Good Clinical Practices (GCPs), company standards, policies and procedures, and the Principles of Medical Research and are aligned with the medical vision.

The CP may be called upon to participate on additional items including but not limited to internal executive and governance presentations, external key opinion leader interactions, medical outreach/advocacy, and industry conferences.

What You Will Do:

Your role will involve delivering clinical pharmacology and pharmacokinetics work to a high standard, working closely with your team and stakeholders.

Key responsibilities include:

• Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision or regulatory submission
• Support preparation of high-level plan for phase 2 and 3 studies for early phase and/or detailed biopharm plan to support submission
• Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies
• Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug disease response models
• Contribute, as an integral member of the Clinical Pharmacology team, to global Phase I and II clinical studies as well as submission planning activities
• Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and preclinical development
• Work with Brand Team/Business Unit colleagues to provide appropriate market differentiation and regulatory support in the biopharm submission plan
• Design and oversee implementation of all clinical pharmacology studies. Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and patient groups/special populations
• Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research
• Design and oversee implementation methods for development and biomarker qualification studies
• Design, create, and provide oversight for protocol development
• Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements
• Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements
• Participate in investigator identification and selection, in conjunction with the clinical pharmacology sourcing group

Your Profile:

Required qualifications and experience:

• Life science degree (MD, PhD, PharmD) with requisite experience in Clinical Pharmacology
• PhD preferrable but not required
• Experience in Pharmaceutics and Product Design preferrable
• Knowledge of and experience in Clinical Pharmacology and drug development process preferred
• Fluent in English; both written and verbal communications
• Interpersonal, organizational and negotiation skills
• Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
• Excellent teamwork skills
• Willing to engage in domestic and international travel to the degree appropriate to support the business of the 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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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

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.

Are you a current ICON Employee? Please click here to apply

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Location

Multiple US Locations

Reference: JR163685

Categories Medical & Scientific Affairs

ICON Strategic Solutions (FSP)

Remote

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