Clinical Pharmacology Consultant

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

This role is a project-based consulting opportunity.

Responsibilities: 

• Strong understanding of technical aspects and standard methodologies in Clinical Pharmacokinetics and Pharmacology (PK/PD), experience in designing and executing Clinical Pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical data.
• Experience leading Clinical Pharmacology aspects of programs at all stages of development and experience with writing and defending the Clinical Pharmacology sections of regulatory submissions (pre-IND through late-stage-development).
• Capable of designing Clinical Pharmacology plans, experience in First-in-Human (FIH) dose determination, dosing schedule and clinical trial design, bioequivalence and bioavailability studies.
• Maintains a strong understanding of regulatory considerations in execution of clinical PK/PD studies in different patient population
• Capable of designing of appropriate modeling plans.
• Strong data analysis skills and an in-depth knowledge of population PK/PD principles, including their interpretation and integration with safety and efficacy data to ensure appropriate dosing regimen decisions are made.
• Understands clinical biomarkers and pharmacogenomics applications to clinical trial design and patient outcomes.
• Understands the ethical aspects of clinical trial research, clinical regulatory requirements and is knowledgeable in ICH and GCP guidelines.
• Interacts with global regulatory authorities, attends meetings with regulatory authorities and provides input on clinical PK/DP questions received from regulatory authorities (e.g., End of Phase 2, pre-IND, pre-NDA / MAA, Advisory Committee meetings).
• Applies appropriate regulatory (e.g., FDA, EMA, ICH, etc.) guidelines and defines regulatory strategy for clinical PK/PD and prepares clinical PK/PD contributions to regulatory documents including IBs, IND’s, briefing books, submission packages, responses to health authority questions, and other regulatory documents.
• Experience in gap assessment review.
• Good written and verbal communication skills.

Requirements:

• 10+ years of experience in Clinical Pharmacology within the CRO, Pharma, or Biotech industry
• Advanced degree in a scientific, medical or clinical discipline
• Expert knowledge of scientific principles and concepts
• Proficiency with MS Office applications
• Hands-on experience with clinical trial and pharmaceutical development preferred              
• Good communication skills and willingness to work with others to clearly understand needs and solve problems
• Excellent problem-solving skills
• Good organizational and communication skills
• Familiarity with current ISO 9001 and ISO 27001 standards preferred
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements
• Basic understanding of CROs and scientific and clinical data/ terminology, and the drug development process

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