Director, Clinical Data Management
Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
DIRECTOR, CLINICAL DATA MANAGEMENT
The Director of Clinical Data Management is accountable for providing strategic and tactical planning, organization and direction of clinical data management as part of the drug development organization within Ionis Pharmaceuticals, Inc.
- Leads and oversees Clinical Data Management function and EDC programming (through external vendors)
- Provides leadership within Clinical Data Management by collaborating with internal and external stakeholders to optimize data management technology, processes and standards and to enable successful execution of corporate objectives
- Identifies ways to continuously improve all aspects of data management and implements solutions; strengthens and enhances the data management service, operations, and execution
- Coaches, develops and provides continuous feedback to a team of direct reports; provide guidance and direction to ensure departmental and client/project goals are met
- Responsible for hiring, training, development and management of staff; ensures effective resource allocation
- Serves as the lead liaison to internal and external clients
- Develops and tracks metrics on productivity and quality and creates strategies and best practices to increase efficiency and quality
- Responsible for overseeing all data management activities leading up to and including interim and/or final database locks inclusive of interacting with the appropriate cross-functional staff: Clinical Operations, Biostatistics and programming to meet Company’s objectives
- Develops departmental policy, standard operating procedures, and work instructions
- Ensures that standards are applied across studies (EDC Builds, CRFs, CRF Completion Manuals, Edit Checks, etc.)
- Oversee the development and validation EDC study builds and the associated data listings, reports, data transfers and detailed timelines
- Monitors data management workflow and tracks project metrics
- Defines CRF standards, oversees individual study CRF design and production
- Develops department goals and objectives and implements plans to meet the them
- Manages department budget development to forecast
- Identifies need for external support; negotiates agreements to secure contract staff and/or vendors
- Oversees selection and management of study vendors
- Leads strategic planning and execution of the department’s objectives including timeline and budget projections, risk mitigation strategies, and data management governance
- Effectively interfaces with Senior Management and other functional areas to assure coordinated expectations and deliverables from Clinical Data Management
- Ensures that the clinical programs are executed in compliance with ICH Guidelines, GCP and CRF Part 11, and any other local requirements
COMPETENCIES IDENTIFIED FOR SUCCESS:
- Proven track record in providing successful leadership in data management
- Demonstrated ability to identify and execute staff development strategies
- Solid analytical and proactive problems solving skills
- Strong interpersonal skills
- Demonstrated skills in continuous improvement, project management, change management, and risk management
- Effective written and verbal communication skills
- Outstanding organizational skills with the ability to multi-task and prioritize
EDUCATION, EXPERIENCE, AND OTHER REQUIREMENTS:
- Bachelor’s Degree; advanced degree in related field preferred
- Minimum of fifteen (15) years of relevant data management experience, including five (5) years in a supervisory role, either as a functional/line manager or co-accountable for performance management within a team matrix, or combination of equivalent experience
- Comprehensive knowledge of GCP, ICH, CFR Part 11 and computer systems validation; sufficient knowledge of Competent Authority regulations in regions outside the US
- Proficiency with web-based EDC systems
- Experience with medical coding preferred
- Experience with SAS programing preferred
- Demonstrated knowledge in several relevant therapeutic areas
- Advanced computer skills in Word, Excel, PowerPoint, and MS Project
- Travel may be required
Excellent salary and benefits package offered.
For more information about Ionis and to apply for this position, please visit our website, www.ionispharma.com. Reference Requisition #18-0086
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.