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 :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

Experience / The Ideal for Successful Entry into Job :

Knowledge / Skills :

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.

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

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $258,000 - $366,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

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.