Executive Regulatory Science & Strategy Director, Oncology

Role Summary

The Executive Regulatory Science Director provides global strategic regulatory expertise and oversight to support the research, development and commercialization of products across small molecules and biologics. This role is within the Oncology therapy area, leading the Hematology group.

Responsibilities

• Coach and mentor regional (US and EU regulatory leads) and global regulatory leads, including identification of skill development opportunities for regulatory professionals at different experience levels.
• Partner with Regulatory Affairs Directors aligning on global innovative regulatory strategies for products.
• Lead resource planning and recruitment of staff.
• Provide critical review and input on disease area and portfolio regulatory strategies, risk planning and mitigations.
• Effectively represent the Global Regulatory Affairs function in senior-level interactions at governance technical review committees, key global health authority meetings and with external partners.
• Collaborate with regional policy and intelligence groups to analyze emerging science, data and regulatory changes, advising senior management on project risks and mitigation activities.
• Define and drive disease area global regulatory policies and priorities.
• Review and approve high-level documents for global regulatory submissions and core prescribing information.
• Ensure submission excellence framework is timely and consistently applied across projects, sharing best submission practices and utilizing existing tools.
• Sponsor key non-drug project workstreams, business initiatives, external activities and meetings as a subject matter expert.

Qualifications

• Required: Bachelor’s degree in life sciences or related field and/or equivalent knowledge/experience.
• Required: More than 10 years of drug development experience.
• Required: Oncology therapy area knowledge/experience, ideally with Hematology assets.
• Required: Deep knowledge of global regulatory strategy across all phases of oncology drug development, including early development and involvement in marketing applications progressed to registration.
• Required: Significant experience leading major health Authority interactions.
• Required: Proven experience growing high-performance teams, attracting top talent, and developing capabilities of regional and global regulatory leads; experience leading in a matrixed environment.
• Required: Ability to think strategically and critically to evaluate risks to regulatory product development, approval, market entry and license maintenance.
• Required: Ability to travel domestically and internationally.
• Preferred: Advanced degree in a scientific subject area (e.g., MSc, PhD, PharmD, MD).

Skills

• Strategic regulatory thinking and risk assessment
• Leadership and people development in a matrixed organization
• Regulatory policy interpretation and long-range planning
• Excellent stakeholder management and communication at senior levels
• Strong collaboration with policy and intelligence groups

Education

• Bachelor’s degree in life sciences or related field
• Preferred: Advanced degree (MSc, PhD, PharmD, MD)

Additional Requirements

• Ability to travel domestically and internationally