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Purpose:
The Associate Director, Study Build Programming is accountable for leading staff in the study build programming work, driving prioritization and alignment of study deliverables and realizing improvements in study build programming activities and processes. The scope of the Associate Director role includes elements of clinical research from early clinical development to post launch clinical research activities. The Associate Director is responsible for recruiting and developing staff to enhance scientific, technical, and operational depth. This role requires an in depth understanding of study build programming, including data collection, data flow management, data quality & integrity, data standards and relevant systems and processes.
Primary Responsibilities:
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
Portfolio Delivery
▪ Lead Team Leaders/managers in delivering on the assigned Therapeutic Area portfolio
▪ Partner with other clinical leaders to deliver standardized data collection methods and innovative validation methods
▪ Provide directions to the Team Leaders/managers in project decisions related to study build programming options and resourcing
▪ Ensure strong linkages exist between study build, execution and archival
▪ Partner closely with Data and Analytics leadership and other functions to effectively plan, forecast, and manage the study build, validation resources required to deliver all sanctioned projects
▪ Drive efficiency and continuous improvement in the Data and Analytics organization
▪ Identify key functional capability gaps early enough to help ensure robust processes in place to meet team needs and/or manage expectations to avoid downstream delivery delays
▪ Contribute to building and implementing departmental strategies for portfolio delivery
Enterprise Leadership
▪ Within functional and cross-functional teams, exhibit strong business acumen, strong problem-solving skills and agility to adjust to changing business priorities and needs
▪ Represent the Data and Analytics organization at appropriate internal and external venues.
▪ Maintain awareness of regulatory requirements, particularly those related to the US, EU, Japan, and China
▪ Ensure that activities are performed according to established guidelines, best practices, and in compliance with all laws and regulations
▪ Identify continuous improvement opportunities and help drive continuous improvement of key performance metrics
▪ Drive shared learning and process expertise
▪ Proactively drive the use of data processes and tools to accelerate study build programming activities and deliverables
▪ Contribute to risk management efforts including risk identification and mitigation at the departmental level
▪ Articulate the value of data solutions in terms of reliability, time, cost, quality and scalability
People Management and Development
▪ Recruit, develop, and retain a scientific, technical, and operationally capable workforce skilled and knowledgeable in study build programming
▪ Effectively create and manage an agile organization that continuously meets the needs of a changing portfolio
▪ Develop staff who demonstrate expertise in data collection technologies, drug development, therapeutic area science and project management
▪ Develop an organizational talent base that demonstrates judgment-based decision making, and provides leadership in study build programming delivery
▪ Provide technical leadership, mentoring, coaching, and example to the community of study build programming professionals operating across the Data and Analytics organization.
▪ Build an organizational culture that fosters inclusion, innovation, promotes diversity
▪ Contribute to developing and implementing people strategies to attract and retain top talent
▪ Provide guidance and support to the team leaders in building and maintaining a high-performance culture
Minimum Qualification Requirements:
▪ Bachelor’s degree , Advanced degree is a plus but not mandatory
▪ At least 12 years of overall work experience with at least 10 years of relevant experience in a pharmaceutical, CRO or biotech
▪ Demonstrated ability to effectively partner/influence to deliver results
▪ Demonstrated ability in leading diverse teams
▪ Demonstrated ability to understand and apply study build programming skills, including data flow, data quality & integrity, data interchange, data mining, and data representation principle
Additional Preferences:
• Advanced degree (e.g. MSc, PhD) in a scientific or technical field
• Proven ability to lead development of creative data solutions to address clinical development challenges
• Proven ability to develop diverse organizational talent with next level potential
• Domestic and international travel may be required
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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