VP, Regulatory Affairs Strategy

SUMMARY/JOB PURPOSE: The Vice President, Regulatory Affairs provides strategic leadership and oversight to the Regulatory Affairs organization, and is responsible for developing and directing regulatory strategy, objectives, policies and programs from early stage development through marketing approval and life cycle management. Essential Duties And Responsibilities: •Identify and recommend development plans incorporating regulatory strategies designed to utilize efficient regulatory pathways and to maximize chances of successful registration. •Oversee the planning and implementation of meetings with regulatory agencies and effectively represent Exelixis at regulatory agencies. •Lead the development of strategic plans in partnership with SVP and oversee tactical implementation execution leading to the creation and submission of regulatory documents, e.g., INDs, NDAs, CTAs, MAAs, and other relevant regulatory filings, ensuring compliance with applicable regulations. •Critically evaluate documents submitted to regulatory agencies to ensure that they are complete, well organized, scientifically accurate, of high-quality, in compliance, and presented in a way that facilitates agency review and fulfills strategic goals and objectives. •Monitor current and proposed regulatory issues and trends and advise management on events of significance for Exelixis’ business interests. •Identify and implement processes, procedures, and solutions for optimization and efficiency commensurate with departmental growth •Provide Regulatory assessment to due diligence teams in terms of risks, requirements, and opportunities associated with potential in-licensed assets •Build relationships and partnerships with vendors, licensors and joint development collaborators, aligning on regulatory strategies, deliverables, and goals. •Build, develop and retain a talented and engaged team of regulatory affairs professionals, set a compelling vision, and motivate and inspire teams to work effectively both inside the regulatory area, cross-functionally, and with external partners Supervisory Responsibilities: •Directly supervises employee(s) •Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: •Bachelor’s degree in related discipline and a minimum of twenty-one years of related experience; or, •Master’s degree in related discipline and a minimum of nineteen years of related experience; or, •PhD degree in related discipline and a minimum of seventeen years of related experience; or, •Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: •Proven leader with a minimum of 15 years of pharmaceutical/biotech industry experience •Possesses a track record of success in leading regulatory affairs activities across multiple phases of development with at least 12 years of regulatory experience in development programs Knowledge/Skills: •Deep knowledge and understanding of the drug development process and regulatory requirements and environment •Minimum of 5 years recent oncology therapeutic area experience required •Experienced in the full range of regulatory submissions from IND to NDA and ex-US equivalents •Significant number of years successfully working with the FDA, utilizing novel regulatory pathways and applying creative approaches during negotiations •Demonstrated strategic thinking ability and drive for successful regulatory outcomes •Creative, analytical problem solver who acts decisively, yet communicates the risks and benefits associated with all potential solutions so that informed business decisions can be made •Strong leadership, verbal and written communication skills and a demonstrated ability to develop constructive and effective relationships with direct reports, colleagues and senior management •Proven ability to build and lead effective, well integrated, collaborative teams and empower team members •Strong interpersonal skills and the ability to skillfully and appropriately manage, develop and mentor personnel in a matrix environment •Results oriented with strong initiative and accountability JOB COMPLEXITY: Working Conditions: #LI-MB1 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 several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $313,000 - $363,000 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. 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.

Salary : $313,000 - $363,000