Sr Director, Regulatory Strategy

SUMMARY/JOB PURPOSE:

Manages all regulatory activities for new development programs, pre-IND through BLA/NDA and post approval, with a particular focus on biologics (ADCs, bispecifics, and etc.). Responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines, as well as companion diagnostics, as appropriate. Provides expertise in translating regulatory requirements into practical, workable plans.

Essential Duties And Responsibilities:

• Lead and oversee development plans incorporating regulatory strategies designed to maximize chances of successful and expedient registration.

• Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early through late stage development programs. Manage clinical development program planning to anticipate changes in regulatory environment and approval requirements.

• Conduct effective and timely regulatory intelligence and research. Monitor current and proposed regulatory issues. Provide risk assessments and recommendations for various regulatory scenarios.

• Work with external vendors to plan, prepare, submit, and maintain CTAs in Europe, Asia, and other regions

• Critically review nonclinical, chemistry, manufacturing and controls, and clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance. Provides regulatory strategic guidance on documents and submission plans to align with study and company objectives.

• Interact directly with regulatory agencies; manages agency interactions.

• Ensure submissions to regulatory health authorities are complete, organized, of high quality, and compliant with applicable regional regulations.

• May assist with due diligence to support business development opportunities.

• Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimization and efficiency commensurate with departmental growth.

• Provide leadership within the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations.

• Liaise internally with members of Exelixis’ functional departments.

• Liaise externally with vendors, licensors and joint development collaborators.

Supervisory Responsibilities:

• Directly supervise employees.

• Indirectly supervise employee(s) through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of fifteen years of related experience; or,

• MS/MA degree in related discipline and a minimum of thirteen years of related experience; or,

• PhD in related discipline and a minimum of twelve years of related experience; or,

• Equivalent combination of education and experience.

• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Minimum sixteen years pharmaceutical industry and/or regulatory agency experience or the equivalent combination of experience and education/training

• Minimum nine years regulatory experience in a position of substantial responsibility.

• Prior experience working with the relevant review divisions at FDA. Experience working with CDRH is preferred.

• Experience in oncology drug development required.

• Prior regulatory leadership role in the development program for a biologic (preferably in oncology) is required.

Knowledge/Skills:

• Demonstrated knowledge of US and international regulatory requirements.

• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.

• Develops technical and/or business solutions to complex problems.

• Exercises problem solving, strategic thinking skills with ability to impact and influence

• Guides the successful completion of major programs, projects and/or functions.

• Interprets, executes and recommends modifications to departmental and cross-functional processes and standards.

• Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.