Commercial Regulatory Affairs Senior Director at Exelixis, Inc. in Alameda, California

Job Description:

Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Position Description:

Responsible for primary regulatory review of promotional materials. Provides regulatory strategic and operational leadership in the areas of advertising and promotion. This role demonstrates proficiency in understanding and interpreting clinical trial data to support Regulatory and cross-functional activities for Exelixis compounds. This role recognizes the different requirements and restrictions for external data communication and presentation and represents the Regulatory considerations and point of view. This role demonstrates cross-functional leadership, recognizing opportunities for multi-disciplinary collaboration and challenges regarding communication strategies and initiatives that cross multiple channels. A suitable candidate for this role will have had Regulatory responsibilities in Promotional Review Committees and/or Scientific Exchange Materials Review committees.

Position Requirements:

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provides strategic and forward-looking guidance regarding processes and systems surrounding review committees.
• Provides leadership within the Regulatory department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations.
• Provides regulatory guidance for the development, review, implementation, and maintenance of promotional materials and other related activities with a high level of independence.
• Chairs promotional review committee meetings and effectively collaborates with cross-functional internal groups.
• Responsibility and oversight of promotional material submissions under Form FDA 2253.
• Manages the development of relevant correspondence with health authorities and interpretation of health authority comments, as well as serving as the primary liaison with relevant personnel in FDA's Office of Prescription Drug Promotion.
• Maintains current awareness of evolving health authority interpretations, including advisory letters, enforcement letters and policy issues. Communicates significant changes or other relevant matters to internal partners and stakeholders.
• Reviews and evaluates industry environment; performs competitive intelligence on promotional materials and activities.
• Manages, maintains, and continuously improves processes and systems (including a web-based platform) for review and approval of promotional materials. Oversees and manages training on processes and systems.
• Leads creation and maintenance of SOPs and work instructions for review, approval, and maintenance of promotional materials.
• Mentors and provides oversight to junior department members supporting Commercial Regulatory Affairs activities.
• Oversight for the regulatory review and approval of scientific exchange materials, including Medical Information requests, materials for the Medical Affairs field staff, and clinical trial support materials (e.g., external patient recruitment materials).
• Oversight of clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters.
• Liaises cross-functionally with partners in Commercial, Medical Affairs, Regulatory, Legal, Public Relations, and others to develop holistic strategies around communication initiatives, working within the regulatory framework and boundaries.

SUPERVISORY RESPONSIBILITIES:
• Directly supervise employees.
• Indirectly supervise employee(s) through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
• Bachelor's degree in related discipline and a minimum of fifteen years of related experience; or,
• Master's degree in related discipline and a minimum of thirteen years of related experience; or,
• PhD degree in related discipline and a minimum of twelve years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal Candidate will have:
• 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 OPDP and/or review divisions at FDA required.
• Experience in oncology preferred.

Knowledge/Skills:
• Demonstrated knowledge of US and international regulatory requirements pertinent to this role.
• 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.
• Trains staff.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to departmental and team colleagues
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Collaborates and communicates effectively through all levels of management across multiple departments and functions.
• Consistently meets deadlines without compromise to work with a high level of independence
• Effective cross-functional collaborator and communicator with demonstrated ability to inspire others around a common goal
• Uses broad expertise and knowledge 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.

WORKING CONDITIONS:
G&A and Development/Alameda:
• Environment: primarily working indoors, performing clerical work

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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.