Clinical Pharmacology II

Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: September 17, 2020

Job Description:

Clinical Pharmacologist II will perform highly scientific functions in support of the companys Clinical Pharmacology area with some guidance and mentoring on complex clinical pharmacology issues. He/She will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed. The candidate will have a good knowledge of related disciplines which interact with the Clinical Pharmacology activities.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS

* Representation for clinical pharmacology on clinical subteams and study teams * General responsibilities: refer to the Key Responsibilities section below * Required skills:

* Critical thinking skills, with keen scientific and development judgment * Skill to supervise or conduct clinical studies such as drug-drug interaction, special population or bioavailability, working with Vertex teams * Skill to conduct non-compartmental pharmacokinetic (PK) and PK/pharmacodynamic analyses * Skill to provide support for other studies such as first-in-human, proof-of-concept or registrational studies * Skill to understand cross-functional needs, develop critical rationale, communicate clearly, collaborate with peers and drive innovation * Skill to ensure close collaboration of Clinical Pharmacology with Modeling and Simulation and Biomarkers within the Translational Medical Sciences Division

KEY RESPONSIBILITIES:

* Guide metabolic, co-dosing and drug-drug interaction issues, collaborating closely with cross functional colleagues * Create protocol concepts and guide protocol start-up including site initiations and investigator meetings

* Participate in study teams, oversee study progression including protocol conduct, data analyses, internal decision points and final reporting * Assist in contract research organization management * Collaborate with other functions to guide program deliverables * Contribute to clinical pharmacology summary documents * Perform PK analyses * Perform PK/PD or exploratory analyses or guide such analyses as appropriate * Guide and/or assist with PK/PD modeling or simulations * Prepare analytical reports including clinical study reports * Collaborate and/or co-direct modeling plans * Interface with external partners * Collaborate internally to ensure appropriate program representation and timely data analysis work streams * Maintain a high standard for good clinical practice, compliance and ethics * Oversee publications and abstracts

PREFERRED EDUCATION AND EXPERIENCE:

* Minimum education and experience requirements: PharmD, Ph.D., 2-3 years of industry or regulatory agency experience

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Keywords: Vertex Pharmaceuticals Inc (US), Boston , Clinical Pharmacology II, Healthcare , Boston, Massachusetts