Day One Biopharmaceuticals is hiring a
Director Regulatory Science

Summary

The Director, Regulatory Science will be responsible for developing and implementing the global regulatory strategy for one or more oncology development programs. The role requires at least 10 years of regulatory experience in pharma/biotech industry, with antibody-drug conjugate and/or biologics experience strongly preferred. The position offers a salary range of $215,000 - $230,000 and competitive benefits.

Requirements

• At a minimum, a BA/BS degree; Master’s/PhD/PharmD in life sciences preferred
• At least 10 years of regulatory experience in pharma/biotech industry
• Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions
• Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others
• Excellent verbal, written, negotiation, influence and interpersonal communication skills are required
• Ability to work independently, establish priorities, and execute with minimal guidance

Responsibilities

• Deliver sound regulatory strategy to Project Team(s) as the Regulatory Science subject matter expert
• Identify and propose risk mitigation strategies, and influence project teams and sub-teams
• Ensure regulatory strategy takes account of competitive developments, regulatory precedent, expert feedback, and that advice is aligned with company goals and objectives
• Serve as regulatory liaison to FDA
• Motivate, mentor, and develop direct report(s)
• Establish highly collaborative and effective relationships with cross-functional colleagues
• Serve as an expert resource for regulatory advice across departments
• Contribute to process improvements

Preferred Qualifications

• Antibody-Drug Conjugate and/or biologics experience strongly preferred
• Direct experience with oncology drug development strongly preferred

Benefits

• The salary range for this position is $215,000 - $230,000
• Day One Biopharmaceuticals offers competitive benefits. Please visit https://www.dayonebio.com/benefits to see the details