Description
Director, Medical Evidence Generation Program & Operations Leader
The Evidence Generation team, part of Global Medical Affairs, is responsible for developing, generating, and delivering evidence that supports the lifecycle, regulatory, and payer strategies for Kite’s products. The function leads the implementation of the integrated evidence‑generation strategy across interventional and non‑interventional programs, including Investigator‑Initiated Research, collaborative clinical research, real-world evidence (RWE), health economics and outcomes research (HEOR), and strategic partnerships.
The Director, Evidence Generation Program & Operations Lead within Kite’s Medical Affairs Evidence Generation (EG) function provides leadership, operational strategy, and delivery excellence for global collaborative clinical trials and non-clinical studies (e.g., External Comparator Arm Studies, Phase IV studies, non-interventional and pre-clinical studies.). This role is central to delivering high-quality, high-impact evidence across phases and therapeutic areas, supporting Kite’s mission to bring transformative cell therapies to patients.
The role sets the framework for successful study execution, ensuring alignment with business objectives, regulatory expectations, and quality standards. As a leader, the role drives critical decision-making, risk management, operational innovation, and continuous improvement.
The role leads a team comprised of Program managers and oversees relationships with external vendors to ensure high-quality, on-time delivery of collaborative clinical and Real-World Evidence (RWE) programs. The Director collaborates broadly within Medical Affairs and with other key stakeholders to drive operational efficiencies and consistency.
The role is accountable for establishing and maintaining fit-for-purpose operational frameworks, including standard operating procedures (SOPs), work instructions, and operational models, to support compliant, inspection-ready execution of collaborative clinical trials and Evidence Generation studies. This includes ensuring operational readiness for regulatory inspection and audit through strong partnership with Quality, Regulatory, and Safety functions, while embedding quality-by-design principles across program execution.
Key Responsibilities
Project & Operation Management
1. Provide operational leadership and oversight for multiple collaborative clinical trials and RWE programs (External Control Arms, etc), ensuring delivery of high-quality data and adherence to regulatory and compliance standards.
2. Establish, implement, and maintain operational SOPs, procedures, and guidance documents governing collaborative clinical trials and Evidence Generation activities, ensuring alignment with GCP/GxP requirements and internal quality standards.
3. Partner with Quality, Regulatory Affairs, and Safety to ensure Evidence Generation programs are inspection-ready, including support for audits, inspections, CAPAs, and health authority interactions as needed.
4. Ensure consistent application of SOPs and procedural controls across internal teams, CROs, and external collaborators.
5. Embed quality-by-design and risk-based approaches into study planning, execution, and oversight for collaborative clinical trials.
6. Lead collaboration with internal teams and external vendors to ensure delivery against timelines, budgets, and quality benchmarks.
7. Provide strategic input into feasibility assessments and oversee operational execution across internal Evidence Generation teams and CRO partners.
8. Proactively identify and manage operational risks; evaluate trade-offs between quality, cost, scope, and timelines.
9. Manage study-level budgets, including contracts, scopes of work (SOWs), accruals, forecasts, and invoice reconciliation for a portfolio or programs.
10. Participate in vendor selection, evaluation, and ongoing governance, ensuring alignment with contractual and Kite standards.
11. Establish and monitor operational performance metrics, drive issue resolution and optimization strategies.
12. Maintain accurate data and documentation within study management systems (e.g., GILDA).
13. Develop and maintain core project management tools such as action logs, decision trackers, and risk mitigation plans.
14. Champion operational excellence and innovation; build scalable processes aligned with Evidence Generation strategy.
Program & Study Oversight
15. Lead strategic planning and execution of collaborative clinical and non-clinical Evidence Generation activities.
16. Provide end-to-end lifecycle oversight from start-up through close-out.
17. Lead cross-functional Study Teams, ensuring strong partnership with Clinical logistics, Regulatory, Safety, and other stakeholders.
18. Identify procedural, compliance, or organizational gaps; develop and implement SOPs, governance models, or process improvements; and drive continuous improvement to ensure regulatory-ready execution of collaborative clinical trials.
19. Build and maintain strong relationships with internal partners, external collaborators, and CROs to maximize program success.
Risk & Quality Management
20. Demonstrates advanced ability to identify, mitigate, and resolve risks that impact trial continuity or data quality.
21. Maintains GCP/GxP compliance; ensures audit readiness and fosters a strong culture of quality.
22. Demonstrated experience developing or operationalizing SOPs and procedural frameworks in regulated clinical research environments.
23. Proven ability to operationalize inspection readiness and quality systems within complex, matrixed, and externally partnered study models.
Basic Qualifications:
24. Bachelor's Degree or Masters' Degree or PhD/ PharmD in life science
Preferred Qualifications:
25. Oncology, Cell Therapy experience
26. Complete knowledge of full cycle study management, from start-up to close-out.
27. Advanced knowledge of clinical study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
28. Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
29. Strong self-management and organizational skills; ability to manage workload, set priorities and adjust as needed.
30. Demonstrated effectiveness coaching, guiding and directing the work of others, effectively managing performance of others, and developing team capabilities.
31. Ability to establish and maintain strong long-term relationships with internal and external key stakeholders.
32. Demonstrates advanced ability to identify, mitigate, and resolve risks that impact trial continuity or data quality.
People Leader Accountabilities:
33. Create Inclusion - knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way they manage their teams.
34. 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.
35. 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.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.