Director, Regulatory Science

Duties and Responsibilities

• Deliver a sound regulatory strategy to program teams.
• Motivate, mentor, and develop direct reports.
• Ensure drug development programs are fully resourced for applicable stages of development.
• Anticipate upcoming work; ensure robust and effective regulatory strategy support.
• Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectives.
• Ensure regulatory advice, policy, and decision-making are consistent across programs and that learnings from one program are fully considered in all other programs.
• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality, and other functions to ensure cross-functional alignment and team effectiveness.

Requirements and Qualifications

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs, including regulatory strategy and leadership roles.
• Demonstrated success in leading regulatory submissions globally.
• Direct experience with oncology drug development.
• Experienced in representing Regulatory on cross-functional teams and presenting to senior management.
• Excellent communicator.
• Excellent planning and organizational skills, and the ability to work simultaneously on multiple projects with tight timelines.

Preferred Qualifications

• An advanced degree is desirable.
• Experience with combination studies, multiple expansion cohorts, basket or umbrella, and master protocols is highly preferred.
• Prior NDA experience is highly preferred.

Desired Skills and Experience

• Regulatory strategy, Regulatory Science, Regulatory Affairs, global regulatory submissions, oncology drug development, drug development programs, clinical-stage regulatory strategy, cross-functional leadership, program team support, regulatory policy, regulatory decision-making, competitive landscape assessment, expert feedback integration, senior management presentations, Clinical Research collaboration, Clinical Operations collaboration, Medical Writing collaboration, Quality collaboration, regulatory resourcing, team leadership, mentoring and development, multiple project planning, tight timeline management, combination studies, expansion cohorts, basket trials, umbrella trials, master protocols, NDA experience, pharmaceutical industry, biotechnology industry