Clinical Pharmacologist

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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.