Associate Director, External Research Program

Descripción del trabajo

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.

Kite’s External Research Program (ERP) advances our enterprise portfolio through external innovation and data generation. This role will oversee investigator-sponsored and collaborative studies and relationships with strategic alliance partners for a select portfolio and contribute to operational best practices as the portfolio scales.

In your role, you will:

• Manage day-to-day administration and operations for ISRs, collaborative and non-interventional studies from concept approval to study closure:

  • Lead global, regional, and local Medical Affairs teams, Translational Medicine, Safety to review protocols and research plans

  • Work with Kite & Gilead partners to carry out budget analyses, regulatory submission support and contract negotiations

  • Ensure clinical demand accuracy, clinical logistics preparation and Tech Ops readiness efforts by tracking institutional start up activities and ensuring timely progress (e.g., GANTT charts, reports, etc.)

  • Monitor study milestones (e.g., deliverables, enrollment status, publications) and process monthly invoicing to support financial forecast accuracy

  • Communicate frequently with external institutions to assure compliance with research activities and provides direction for those institutions regarding research, contractual, and milestone compliance, recruitment, and reporting

• Act as Relationship Manager with key strategic collaboration partners to align on strategic objectives, administer governance activities and support partner-of-choice delivery

As a member of the team you will:

• Contribute process improvements and new project management approaches, methods, resources, and capabilities and lead development of process and policy documentation to support evolution of ways of working

• Ensure data compliance and adherence to ERP processes, business conduct policies and SOPs

• Ensure effective, accurate, and timely communication to meet the needs of internal stakeholders

• Demonstrate a partner of choice mindset with external researchers and reinforce standards and expectations for all Kite teams to present externally

• Exhibit Gilead’s core values: integrity, teamwork, accountability, excellence, and inclusion

Preferred Qualifications

• 7+ years of relevant biopharmaceutical experience, including experience working on strategic initiatives, project planning and/or project management

• Strong understanding/experience in clinical and/or pre-clinical research, or experience in Clinical Research/Development, Medical Affairs

• Demonstrated skills and success in relationship building, negotiation and influencing

• Proficient at synthesizing information to support leadership presentations and stakeholder communications

• Excellent communication, project management, problem solving, and organizational skills, including management of multiple priorities and resources while maintaining attention to detail

• Proactive, self-motivated, and resourceful – able to cultivate path forward in ambiguous circumstances and know when to ask for support or escalation

• Experience of working in an international environment and distributed workforce an advantage

• Knowledge and skill with Smartsheet, Microsoft Excel, Word, PowerPoint, Outlook, and other reporting and tracking tools

Basic Qualifications

Doctorate and 2+ years of project management experience

OR

Master’s and 8+ years of project management experience

OR

Bachelor’s and 10+ years of project management experience

OR

Associate and 12+ years of project management experience

OR

High School Diploma/GED and 14+ years of project management experience

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.

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.