Senior Director, Global Regulatory Lead

🕒 March 7

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Logo of Immunome, Inc.

Immunome, Inc.

51 - 200 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Immunome, Inc. is a clinical-stage oncology company dedicated to improving outcomes for cancer patients through the development of innovative therapeutic candidates. With a focus on targeted therapies, Immunome integrates rigorous scientific research to create first-in-class and best-in-class treatments. Their pipeline includes several promising drug candidates, including antibody drug conjugates and radioligand therapies aimed at addressing high unmet medical needs in oncology.

📋 Description

• Define and implement global regulatory strategies that adapt to changing regulatory and business needs. • Communicate key developments to project teams and stakeholders, ensuring alignment and sound judgment. • Lead the Global Regulatory Team, fostering a high-performance culture through coaching and mentoring. • Communicate effectively with internal and external partners, advocating for regulatory positions in governance and cross-functional committees. • Ensure timely preparation and submission of regulatory submissions while maintaining compliance with regional and global requirements. • Monitor industry trends and regulatory changes, adapting strategies to mitigate impacts on product development.

🎯 Requirements

• Bachelor’s degree in a relevant scientific discipline. • A minimum of 10 years experience in global regulatory affairs in the pharmaceutical/biotechnology industry. • Proven success in leading regulatory submissions and obtaining approvals in major markets. • Experience developing oncology therapeutics is strongly preferred

🏖️ Benefits

• Health insurance • 401(k) matching

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