Director, Regulatory Science

September 10

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Day One Biopharmaceuticals

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Cancer drug development comes of age.

Oncology • Cancer • Drug Development • Biotechnology • Pediatric Oncology

11 - 50

Description

• The Director, Regulatory Science will be the regulatory lead for one or more oncology development programs and work closely with cross-functional teams and development partners to execute the global regulatory strategy in line with the Project Team’s goals, Health authority expectations, and ICH requirements. • Support the integrated development plan for a Phase 1 Antibody-Drug Conjugate, and be responsible for developing and implementing the global regulatory strategy. • 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.

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. • Antibody-Drug Conjugate and/or biologics experience strongly preferred. • Direct experience with oncology drug development strongly preferred. • 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 may at times require working outside of “normal” work hours in order to meet business demands and/or health authority timelines.

Benefits

• Competitive benefits