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Global drug and device development services

Clinical Pharmacologist

Clinical Research OperationsPosted on Nov 11
Full-timeRemote in USA

About the Job

Requirements

  • A life science degree (MD, PhD, or PharmD) and requisite experience in Clinical Pharmacology.
  • Fluency in written and spoken English.
  • Interpersonal, organizational, and negotiation skills.
  • Ability to influence others cross-functionally and within the function to create a positive working environment.
  • Teamwork skills.
  • Willingness to travel domestically and internationally as appropriate to support the team's business.

Responsibilities

  • Ensure medical team activities comply with applicable local and international regulations, laws, guidance, Good Clinical Practices, company standards, policies and procedures, and the Principles of Medical Research, and align with the medical vision.
  • Participate as needed in internal executive and governance presentations, external key opinion leader interactions, medical outreach and advocacy, and industry conferences.
  • Contribute to the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decisions or regulatory submissions.
  • Support preparation of high-level plans for Phase 2 and 3 studies for early-phase development and/or detailed biopharm plans to support submissions.
  • Collaborate with Global Patient Safety, PK/PD, ADME, Statistics, and Tailored Therapeutics organization on methods for assessing special clinical safety pharmacology studies.
  • Collaborate with quantitative scientists, including PK/PD, statistics, molecular epidemiology, ADME, and modeling and simulations, to integrate study development and conduct with disease-progression and drug-disease response models.
  • Contribute to global Phase I and II clinical studies and submission-planning activities as an integral member of the Clinical Pharmacology team.
  • Work with discovery research scientists on basic research strategies, clinical candidate compound selection, and preclinical development.
  • Work with Brand Team and Business Unit colleagues to provide market differentiation and regulatory support in the biopharm submission plan.
  • Design clinical pharmacology studies and oversee their implementation, accounting for the specific considerations of studies in healthy volunteers and patient groups or special populations.
  • Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research.
  • Design and oversee methods for development and biomarker qualification studies.
  • Design, create, and provide oversight for protocol development.
  • Support development of study-conduct documents with functional and operations staff and affiliates in accordance with Good Clinical Practice and local requirements.
  • Collaborate with local clinical research staff, statisticians, health outcomes research scientists, consultants, and investigators to develop protocols and data-collection requirements.
  • Participate in investigator identification and selection with the clinical pharmacology sourcing group.

Desired Qualifications

  • A PhD is preferred but not required.
  • Experience in Pharmaceutics and Product Design is preferred.
  • Knowledge of and experience in Clinical Pharmacology and the drug development process is preferred.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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