We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs, and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
POSITION OVERVIEW:
Regulatory Affairs Advertising and Promotion (RA Ad/Promo) is a core function within Kite's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Kite's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead/Kite policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Kite's commercial activities to U.S. regulatory agencies.
You will manage the commercial regulatory strategy and execution of such for multiple high-volume and/or otherwise complex CAR T-cell therapy brands or oncology therapeutic areas. You will represent the commercial regulatory perspective at high-volume Promotional Review Committee (PRC) meetings for complex brand(s). You may lead local or global cross-functional process improvements or other special projects. You will provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to promotional materials with regulatory agencies. You will communicate relevant updates or changes to cross-functional leaders and teams. You may assume a leadership role in advising cross-functional stakeholders on regulations, policies, and enforcement, which may impact Kite's promotional activities.
EXAMPLE RESPONSIBILITIES:
Serves as the commercial regulatory lead for one or more high-volume and complex brands or therapeutic areas without managerial oversight, as appropriate.
Review of promotional, corporate, and other non-promotional materials to assess for compliance with applicable regulations, guidances, and internal policies/best practices.
Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.
Serves as regulatory liaison to FDA/CBER/APLB for assigned product(s) and ensure materials are submitted to FDA in a timely manner.
May lead local or global cross-functional process improvements or other special projects.
Provides regulatory guidance on new marketing concepts, messaging, and campaigns.
May be required to assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling, providing strategic regulatory guidance on corporate communications and appropriate pre-approval communications, and/or updating and advising cross-functional stakeholders on regulations, policies, and enforcement, which may impact the company’s promotional activities.
Represents RA Ad/Promo at Regulatory Project Team/Labeling meetings and provides strategic regulatory guidance.
Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Education & Experience
PharmD/PhD 6+ years’ relevant experience.
MA/MS/MBA with 10+ years’ relevant experience.
BA/BS with 12+ years’ relevant experience.
For external candidates, 4+ years’ experience in regulatory review of promotional materials for prescription drug or biologic products.
Significant experience leading development and execution of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products.
Proven track record in effectively directing the commercial regulatory or related strategy to successful conclusion for multiple products.
Experience chairing/leading promotional review committees or other relevant regulatory governance committees.
Experience working and negotiating with regulatory authorities is preferred.
Line management (direct reports) experience is preferred.
Proven track record of matrix leadership or effective people leadership and management, as evidenced through past effectiveness with employee engagement, development, and retention of matrix team members or direct reports.
Experience working with external contractors supporting the work of regulatory affairs is a plus.
Experience authoring and implementing processes.
Extensive experience participating in cross-functional projects and teams.
Proven track record of successfully managing large scale, complex, time-sensitive projects.
Knowledge & Other Requirements
Expert knowledge of U.S. regulatory requirements for prescription drug and biologic products.
Expert knowledge of all key functions involved in the various stages of marketed medicinal products.
Demonstrates in-depth knowledge of current trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects.
Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.
Working knowledge of relevant regulatory or related systems is preferred.
Demonstrates ability to rapidly learn new therapeutic areas.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
Strong interpersonal skills and understanding of team dynamics.
Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees.
Strong negotiation and conflict resolution skills.
Strong coaching capabilities to mentor/develop direct reports or other team members.
When needed, ability to travel.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Please apply via the Internal Career Opportunities portal in Workday.