Manager, Clinical Logistics Change Management
Job Description
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.
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 world’s 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 Manager of Clinical Logistics Change Management provides end‑to‑end coordination and oversight of clinical logistics change management to support study startup, product lifecycle activities, and operational readiness. It ensures alignment across cross‑functional teams (e.g., IT, ClinOps, ClinDev, CMC Reg, PQ, KCC, RDQ) to enable timely execution of new product introductions and study readiness. Key responsibilities include leading Investigational Product Manual (IPM) development, managing document change controls and revisions, and triaging broader change impacts across clinical logistics. The role ensures system readiness, and adherence to change timelines. Additionally, it drives transparency by tracking and communicating all change management activities impacting clinical logistics, ensuring stakeholders have clear visibility to progress, risks, and readiness milestones.
Responsibilities:
Study Startup Activities
· Engages with GSC EXPAND, IT, and clinical logistics managers in Demand Planning and Systems (amongst others) to enable New Product Introduction (NPI) and Product Variation Management (PVM) Expansion
· Determines impact of study startup activities to clinical logistics by conferring with clinical logistics management
· Coordinates timely execution of change management tasks with impacted clinical logistics owners to ensure timely completion in line with established change control effective dates, and forecasted clinical trial readiness dates
· Works with IT to ensure ERP configuration and readiness to enable clinical logistics activities
· Works with Clinical Logistics Systems manager to ensure Salesforce cell journey orchestration platform configuration and readiness to enable clinical logistics activities
General Change Management
· Receives and triages clinical logistics impact assessments (IA) from across the org unrelated to study startup readiness
o Facilitates review with impacted subfunction/s within ClinLog to ensure timely and accurate IA submission and task completion
· Travel required for stakeholder engagement and conferences
Investigational Product Manual (IPM) Development
· Leads and manages IPM (pharmacy guide) development across all products
· Owns IPM related procedures and Center of Excellence (CoE) charter and meetings
· Engages key cross-functional IPM members and contributors in PD, CMC Reg, PQ, ClinOps, and ClinDev to ensure accuracy and compliance with study and product design
Document Revision Oversight
· Initiates document change controls in Kite’s DCS and coordinates document revisions with process owners in clinical logistics
· Ensures timely revision of documents by process owners in line with change management timelines and clinical trial readiness dates
· Engages RDQ and KCC to ensure adherence to document writing best practice, and compliance.
· Owns and maintains SOPs for change management (not inclusive of other clinical logistics functions)
· Owns internal training material for change management
Reporting
· Tracks and provides visibility to all change management tasks impacting clinical logistics to management and department stakeholders via report and dashboard creation and maintenance
Basic qualifications:
Bachelor's Degree and Six Years' Experience
OR
Masters' Degree and Four Years' Experience
Preferred Qualifications:
Bachelor’s degree in Life Sciences, Supply Chain, Business, or related field preferred
Experience in clinical logistics, clinical operations, or clinical supply chain within the biopharmaceutical industry.
Experience executing and participating in cross functional change control management from inception to effectivity in the biopharmaceutical industry
Strong understanding of end-to-end clinical trial operations, including patient specific logistics, global trial execution, and their impact on operations.
Experience with ERP systems (EBS, SAP, etc.)
Experience with DCS and QMS systems (Veeva, Agile, etc.)
Experience with CRM software (Salesforce, Veeva, etc.)
Experience with clinical trial tools and systems (CTMS, EDC, eTMF, IRT, IXRS, etc.)
Knowledge of GCP, GMP, GxP, ICH principles and regulatory requirements.
Excellent communication, collaboration, and stakeholder management skills.
Strong planning and the ability to create structured, actionable, and adaptable roadmaps while anticipating obstacles
Ability to collaborate across multiple functions.
Ability to manage complexity and multiple priorities in a fast-paced environment.
Proficiency with Microsoft Office, SharePoint, Smartsheet, Salesforce, ThoughtSpot, Spotfire, and other business systems
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:
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.
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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 [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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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.