Executive Director, Regulatory Science Communications

SUMMARY/JOB PURPOSE:

The Executive Director Regulatory Science Communications is responsible for the functional areas of Scientific/Regulatory Writing, Regulatory Editing, and Regulatory Document Quality Control to ensure the timely preparation and submission of critical regulatory documents such as IND/CTA, NDA/BLA/MAA, regulatory responses, briefing documents, clinical protocols, clinical study reports, investigator brochures, and others across all stages of development.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provides expert leadership for each functional area to ensure the timely preparation, completion, and submission of critical regulatory documents.
• Builds and maintains an effective team by recruiting and hiring appropriate personnel to execute tasks related to regulatory document development, publishing, and submission.
• Oversees teams to organize, manage, and execute tasks related to the development of documents, ensuring that timelines and quality standards are met.
• Helps teams negotiate timelines with key stakeholders for documents intended for regulatory submission.
• Oversees the identification, hiring, and managing of consultants for peak workload and specialized projects.
• Actively manages departmental resources and budget to meet strategic goals.
• Oversees development of standards, procedures, and optimized processes for regulatory document development.
• Reviews and contributes to content development and critically assesses, interprets, and summarizes data to produce highquality communications.
• Ensures consistency in documents within and across programs by overseeing the management of messages and developing and maintaining document standards, models, and templates.
• Oversees the development of appropriate SOPs and work instructions for each functional area within the Regulatory Science Communications group.
• Identifies continuous improvement opportunities and acts to improve processes.
• Other duties as needed.

SUPERVISORY RESPONSIBILITIES:

• Directly supervises heads of each functional area: Scientific/Regulatory Writing, Regulatory Editing, and Regulatory Document Quality Control.
• Supervises staff, including hiring, reviewing performance, and recommending salary increases, promotions, transfers, demotions, or terminations.
• May support and direct work of contract scientific specialists.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of 18 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 16 years of related experience; or,
• PhD degree in related discipline and a minimum of 15 years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• PhD degree preferred.
• At least seven years of experience of specific leadership and management experience including managing a team of regulatory and scientific professionals and management of multiple independent and interdependent functions or equivalent preferred.
• Experience and significant participation in preparation of complex documents for regulatory submissions, particularly IND, NDA/BLA/MAA.
• Certification (eg, AMWA, BELS) is preferred.
• Indepth experience with electronic systems including submissions.

Knowledge/Skills:

• Familiarity with the therapeutic area of oncology is essential.
• Good/general knowledge of the AMA Manual of Style, ICH guidelines, Regulatory Affairs and Clinical Development.
• Demonstrates high standards of performance. Manages and effectively communicates priorities. Mobilizes and inspires people and teams to achieve business objectives and deliver individual and team results for areas of responsibility. Resourceful and persistent in overcoming obstacles, even when confronted with ambiguity or barriers, to focus on businesscritical activities. Takes pride in delivering high quality work.
• Applies extensive knowledge of regulatory requirements, industry drivers, and practices to develop innovative and effective working methods. Anticipates potential changes and challenges the status quo to drive continuous improvement.
• Demonstrates the highest standards of written and oral communication. Demonstrates flexibility in selecting communication methods and media appropriate to the message and the audience. Speaks clearly and confidently in all situations and effectively presents to large audiences within and outside Exelixis, inspiring audience engagement.
• Excellent interpersonal skills and ability to incorporate differing views to resolve challenges by influencing agreed upon resolutions. Identifies potential for conflict and takes preventive action.
• Effective builder of high-performing teams. Creates formal and informal networks to foster collaboration among internal and external groups and stakeholders.
• Establishes goals and objectives and manages resources within areas of responsibility to plan for successful outcomes, consistent with Regulatory Affairs strategy.
• Demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve complex problems. Provides regulatory document expertise to cross-functional teams. Understands longerterm consequences of decisions and actions.
• Adaptable leader, able to balance the needs of both task and team, while acting with integrity and building trust, to achieve team objectives and departmental goals. Serves as a role model, encouraging others to behave ethically; takes accountability for self and group actions. Creates an environment where leadership and talent development are top priority, challenges inappropriate attitudes and behavior.
• Capable of strategically and proactively assessing workload, trends, tasks and priorities for cross-functional activity.
• Plans and executes multiple projects or activities, throughout the department, removing barriers and considering alternative methods and contingency plans to avoid potential issues and promote efficiency.
• Designs and implements solutions to address departmental and cross functional challenges, taking into consideration the broader impact.
• Engages, influences and collaborates with stakeholders on cross-functional projects of increased corporate importance.
• Environment: primarily working indoors
• Travel approximately 20%

Work Environment/Physical Demands:

Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.