CRP Lead (Pharmaceuticals)

TL;DR

CRP Lead (Pharmaceuticals): Providing scientific and clinical strategy leadership for insulin assets with an accent on clinical trial design, regulatory compliance, and asset development. Focus on overseeing worldwide regulatory submissions, interpreting efficacy and safety data, and managing interactions with health authorities like FDA and EMEA.

Company

hirify.global is a company focused on the development and leadership of insulin assets and clinical science.

What you will do

• Oversee the design, execution, and reporting of clinical trials ensuring ethical standards and regulatory compliance.
• Provide medical and scientific input for core project documents, including target product profiles (TPP) and protocols.
• Lead the preparation and oversight of worldwide regulatory submissions in partnership with regulatory leadership.
• Manage the dissemination of clinical data through publications, conference presentations, and symposia.
• Act as the primary clinical spokesperson for interactions with government agencies, health authorities (FDA, EMEA), and strategic advisory boards.
• Interpret efficacy and safety data to provide scientific guidance for the organization's asset portfolio.

Requirements

• MD, PhD, or PharmD degree.
• At least 10 years of experience in all phases of clinical development within pharma, biotech, or CRO environments.
• Deep expertise in designing clinical protocols, reports, and preparing INDs, NDAs, and BLAs.
• Strong proficiency in statistics, data analysis, and data interpretation.
• Excellent written and oral communication skills with a command of the English language.

Nice to have

• Specialty therapeutic credentials in a relevant therapeutic domain.
• Experience in Metabolism and Endocrinology (e.g., diabetes, obesity, NASH, CKD).
• Specific experience with insulin/GLP-1.