Sr Director, Regulatory Affairs CMC

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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.

Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

The Senior Director Regulatory CMC CAR T Cell Therapy provides global leadership and strategic direction for CMC regulatory activities across early and late stage development through commercialization of autologous CAR T cell therapy products. This role is accountable for setting and executing global CMC regulatory strategies leading complex submissions managing lifecycle changes and serving as a senior regulatory authority and advisor to cross functional leaders.

The role partners closely with Technical Operations Manufacturing MSAT Process & Analytical Development Quality Global Regulatory Affairs and external partners to enable compliant efficient development and supply of CAR T products across regions.

Key Responsibilities

Global CMC Regulatory Strategy & Leadership

• Define and lead global CMC regulatory strategy for CART programs across early and late clinical development and postapproval lifecycle management.

• Anticipate evolving global expectations for ATMPs/CART and proactively assess regulatory risks opportunities and mitigation strategies.

• Represent Regulatory CMC as a senior leader on crossfunctional governance and core teams.

Regulatory Submissions & Agency Engagements

• Provide executive oversight and critical review of Module 3 / Quality content for clinical and commercial applications.

• Ensure endtoend consistency scientific rigor and regulatory defensibility of CMC dossiers including incontext review of compiled applications and healthauthority responses (e.g. RTQs IRs).

• Serve as a senior CMC subjectmatter expert for health authority interactions including briefing documents and participation in agency meetings.

Change Management & Lifecycle Strategy

• Lead global CMC regulatory assessments for manufacturing and control changes including process evolution site transfers comparability strategies analytical changes and shelflife updates.

• Drive lifecycle strategies that balance regulatory compliance technical feasibility supply continuity and business objectives.

• Oversee complex global LCM planning including sequencing regional differences and submission pathways.

Technical & CrossFunctional Partnership

• Provide strategic regulatory guidance to technical teams throughout product development scaleup validation and commercialization.

• Partner closely with Manufacturing MSAT Quality and external CDMOs to ensure regulatorycompliant execution.

• Review and provide oversight of CMC components supporting labeling product information and related regulatory documents.

Leadership Talent & Operational Excellence

• Lead develop and mentor a team of Regulatory CMC leaders and/or provide strong matrix leadership across programs.

• Set priorities and oversee resources and timelines for a complex portfolio of submissions and lifecycle activities.

• Contribute to the advancement of Regulatory CMC capabilities processes and best practices globally.

• Senior influencer internally and externally on CMC regulatory topics for advanced therapies

Education & Experience

• 14 years of biopharmaceutical industry experience including extensive Regulatory CMC leadership with a bachelors degree or 12 years with a masters degree.

• Advanced degree preferred (PhD PharmD MS or equivalent) in a scientific discipline.

• Deep experience with cell therapy and/or gene therapy products; CART experience strongly preferred.

• Demonstrated success leading global CMC strategies and major submissions (e.g. latestage clinical BLA/MAA postapproval supplements).

• Strong knowledge of ICH guidelines ATMP regulations and global CMC expectations (FDA EMA and key international markets).

Key Competencies

• Strategic and systems thinking with strong regulatory risk assessment skills

• Executivelevel written and verbal communication

• Ability to influence senior leaders and crossfunctional stakeholders

• Sound judgment in complex ambiguous regulatory environments

• Proven people leadership and talent development

People Leader Accountabilities:

Create Inclusion - knowing the business value of diverse teams modeling inclusion and embedding the value of diversity in the

way they manage their teams.

Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current

performance and future potential. They ensure employees are receiving the feedback and insight needed to grow develop and

realize their purpose.

Empower Teams - connect the team to the organization by aligning goals purpose and organizational objectives and holding

them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

For additional benefits information visit:

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

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 disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow 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.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.