Chief Science Officer

About Us

Project Insulin is a non-profit pharmaceutical company committed to making insulin affordable and accessible for all. By producing and distributing generic insulin at cost, we are challenging the status quo of high drug prices. Our streamlined, patient-first approach eliminates unnecessary middlemen, ensuring that those who rely on insulin can access it without financial hardship.

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Role Overview

We are seeking a Fractional Chief Science Officer (CSO) to provide high-level scientific and regulatory leadership as we develop biosimilar insulin. This role is ideal for an experienced biosimilar expert with a strong background in regulatory strategy, clinical development, and contract research organization (CRO) management. As a key member of our leadership team, you will help shape our scientific direction, ensure regulatory compliance, and build strategic partnerships that accelerate our mission.

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Who We’re Looking For

Beyond scientific expertise, we’re looking for a mission-driven leader who shares our values and commitment to healthcare equity. The ideal candidate is passionate about expanding access to affordable medications, believes in the power of non-profit pharmaceutical models, and is motivated by the opportunity to create systemic change.

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Responsibilities

CRO Relationships & External Partnerships:

• Manage relationships with Contract Research Organizations (CROs), ensuring alignment with project goals, timelines, and compliance requirements.
• Identify and evaluate potential research partners that align with Project Insulin’s scientific and operational needs.
• Support fundraising and grant proposals by contributing scientific and technical expertise.

Mentorship & Leadership:

• Provide guidance and mentorship to Project Insulin’s regulatory and scientific teams.
• Support the professional development of internal staff by sharing scientific, regulatory, and industry expertise.
• Engage in high-level strategic discussions to help shape the future of Project Insulin’s drug development.

Regulatory Oversight:

• Advise on regulatory strategy for biosimilar insulin development, ensuring compliance with FDA and global biosimilar regulations.
• Oversee preclinical and clinical study design and assist in regulatory submissions.
• Engage with regulatory agencies and key stakeholders to ensure smooth approval pathways.

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Qualifications

• PhD, MD, or equivalent in biopharmaceutical sciences, bioengineering, pharmacology, or a related field.
• 10+ years of experience in biosimilar drug development, including regulatory strategy and clinical development.
• Proven experience managing CRO relationships and external partnerships.
• Expertise in FDA and global biosimilar approval processes.
• Strong strategic thinking with a passion for advancing healthcare accessibility.

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Why Join Us?

This is a unique opportunity to apply your expertise in biosimilars to drive real change in the insulin market. By joining Project Insulin, you’ll play a key role in building a sustainable, nonprofit model for affordable insulin.

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How to Apply

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