Senior Director, Clinical Data Management

Description de l'emploi

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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

The Senior Director, Clinical Data Management will report to the ED, Clinical Compliance and Data Management of Kite and will lead and manage the function of Data Management. You will also mentor, instruct and manage full time employees and sponsor multiple contracting employees. This is a leadership role involves strategic and tactical capabilities, but also excellence in business processes. You will work closely with leaders in cross functions including but not limited to Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Safety, Manufacturing, Translational Science and Quality. This role will function as the company’s Global Head of Data Management, which provide database programming, data collection, data review, data processing and extractions, for planned and ad hoc data analysis for all clinical studies within the clinical development function. The scope of responsibilities includes but is not limited to leadership, policy-making, global infrastructure development, personnel development, training and oversight, vendor oversight and regulatory guidance within the function.

Job Responsibilities

• Oversee all aspects of the Data Management and Clinical Programming teams including resource planning, deliverables, staff training, staff appraisals, performance reviews, and annual salary reviews
• Develop Data Management Departmental SOPs and ensure staff adherence to company policies, SOPs, federal guidelines and GCPs
• Forecast and manage the department budget both for external and internal spend
• Work closely with Quality and Clinical Compliance to ensure quality and continuous process improvement within clinical trial data management
• Effectively represent Data Management departments at project review meetings, quality review meetings, and other stakeholder meetings
• Lead and provide oversight for the execution of data management for all programs and studies of the company and accountable for all data management and clinical programming activities
• Accountable for delivery of departmental infrastructure projects
• Responsible for managing a highly effective team of Managers and Clinical Data Associates supporting highly complex clinical data management
• Has extensive knowledge and understanding of the business beyond the functional area
• Responsible for instructing the implementation of new or advanced systems, processes and resources to increase productivity
• Guides data management activities for regulatory submissions
• Guides CDM organizational strategy and implements departmental change

Basic Qualifications

Doctorate and 10+ years of data management experience

OR

Master’s and 12+ years of data management experience

OR

Bachelor’s and 14+ years of data management experience

OR

High School Diploma/GED and 18+ years of data management experience

Preferred Qualifications

• 16 years of experience in clinical data management in pharmaceutical industry
• Scientific career background
• Experience in oncology therapeutic area; cellular therapy in oncology experience
• 12 years of managerial experience in data management function and experience in leading mid- to large group of data managers
• Experience in clinical trial database build, case report form design and familiar with CDISC and regulatory requirements
• Excellent oral and written communication skills, project and personnel management skills and organizational skills

The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply.

#LI-ML1

#IND123

The salary range for this position is: $216,070.00 - $279,620.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

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.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.

Gilead 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 log onto your Internal Career Site to apply for this job.