Associate Director, Clinical Data Management

Kite Pharma • Santa Monica, CA

1d

About The Position

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 Associate Director, CDM will be responsible for overseeing all aspects of clinical data management for Kite’s clinical development programs with guidance from the Executive Director, CDM. This position will be responsible for managing Data Managers (DM), CDM vendors, project timelines, working with Programming to create data quality reports, clinical data collection, working with the Standards function to develop and ensure compliance with eCRF standards, and data review. The Associate Director, CDM will also work with Clinical Operations, Safety and Regulatory as necessary.

Requirements

• Bachelor’s degree and 10 years of experience
• Master’s degree and 8 years of experience
• PhD degree and 5 years of experience
• Knowledge and understanding of Good Manufacturing Practices (GMP) and regulatory policies
• Experience in clinical trial database build, case report form design and familiar with CDISC and regulatory requirements
• Excellent oral and written communication skills, Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, Biostatistics, and data management
• Experience with CDISC standards (e.g., CDASH, SDTM)
• Experience managing clinical data management deliverables for regulatory filings
• Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
• Experience with Medidata RAVE including database build, edit check programming, and data extraction
• 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.

Nice To Haves

• Preferred 3-5 of years of experience in oncology therapeutic area
• Cellular therapy in oncology experience a plus
• Proficiency with MS Office Suite
• Ability to identify issues and seek solutions
• Ability to work both independently and collaboratively
• Ability in cross functional teams in fast pace, dynamic team setting
• Efficient, organized, and able to handle short timelines in a fast-paced environment
• Experience and/or interest in the Biotechnology, Pharmaceutical or health-care industry
• Experience with Reporting tools (e.g., Spotfire, Jreview)
• Experience managing vendors (e.g., external, CRO)

Responsibilities

• Project level coordination and day to day oversight of Data Management tasks in the study lifecycle and estimating resourcing needs
• Mentor and provide guidance to Data Managers under their leadership
• Provide CDM expertise for database set up, CRF design, and data cleaning to efficiently ensure high quality data
• Manage vendors, and ensure appropriate resources are available to meet the demands of the assigned clinical trials
• Effectively represent Data Management departments at study team meetings and other leadership meetings
• Manage CDM deliverables in coordination with internal and external cross functional teams.
• Collaborate with Standards on the development of Standards (e.g., eCRF, reporting) and ensure data management compliance
• Collaborate with Programming to create internal data quality checks in support of Data Review on an ongoing basis to ensure quality data
• Lead Data Management process and technology improvement projects
• Provide guidance to study teams and external vendors regarding the technical aspects of clinical database structure
• Work closely with Quality and Compliance to ensure quality and continuous process improvement in clinical trial data management
• Represents data management activities for regulatory audits
• Project and personnel management skills and organizational skills

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level