Sr. Director -Trial Management Systems, Clinical Trial Foundations

BioSpace; Indianapolis (IN); On-site; USD 156,000 - 228,800; Full time

Benefits offered by this job

401(k)

Pension

Medical and dental benefits

Vacation benefits

Well-being benefits

Job summary

A leading healthcare company in Indianapolis is seeking a Sr Director for Clinical Trial Foundations to oversee clinical information management. The role involves developing and implementing strategies for clinical systems, engaging with business partners, and managing fiscal responsibilities. Candidates should have a Bachelor’s degree and extensive experience in clinical drug development along with strong networking and problem-solving skills. The anticipated salary range for this position is $156,000 - $228,800, with additional benefits.

Qualifications

• 5 years of experience in clinical drug development or information flow.
• Ability to set and implement improvement strategies for drug development.
• Demonstrated credibility to influence peers and management.

Responsibilities

• Maintain strategic alignment for clinical systems with user community needs.
• Drive development and quality of clinical systems.
• Manage fiscal responsibilities of related vendors.

Skills

Clinical drug development

Information flow expertise

Strong networking skills

Problem-solving skills

Education

Bachelor’s degree

Tools

Data Sciences

Quality/Regulatory

Job description

About Lilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Purpose

Sr Director roles in Clinical Trial Foundations (CTF) focus on capabilities related to: data capture; data delivery; site platforms, monitoring and eTMF; help desk, external focus, management of pilots, Transcelerate; and Business Process Management and OCM/Coms.

The Sr Director, CTF is a cross‑functional leader and key partner across the business and Tech@Lilly for clinical information management capabilities. They will serve as the clinical system(s) owners and be responsible for the development, implementation and maintenance of the clinical information management and process automation strategy for their area of focus while contributing to the integrated end‑to‑end clinical information automation strategy. They will actively engage with internal and external partners on new operating models, capabilities and technologies. The Sr. Director is responsible for collaborating with Process Owners and CDDA leadership in the development of information management strategies and plans, and working with Tech@Lilly leadership and Third Party Organizations (TPO) to drive plan implementation.

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 supervision regarding your actual job responsibilities and any related duties that may be required for the position.

System and Capability Ownership and Data Flow

• Gain and maintain strategic alignment for clinical systems with the needs of all user communities and related initiatives.
• Define and manage clinical system and/or capability implementation and scale‑up strategy and plan.
• Drive development, use, and quality of clinical systems.
• Serve as clinical system(s) owner.
• Develop, implement, and maintain the clinical information management and process automation strategy for their area of focus while contributing to the integrated end‑to‑end clinical information automation strategy with business and Tech@Lilly partners.
• Accountable for fiscal responsibility of vendors associated with CTF.
• Actively engages with internal and external business partners to evaluate attributes and risk associated with new operating models, capabilities, and technologies.
• Accountable for the delivery and sustainability of projects in CTF.
• Development and implement integrated communication plans across the organization.
• Maintain visibility across interdependencies across projects.
• Foster collaboration amongst stakeholders and facilitate efficient decision‑making.

Enterprise Leadership and External Focus

• Continuously seek and implement improvements to reduce cycle time and decrease work effort resulting in decreased costs that optimize clinical information flow, process and technology.
• In partnership with Tech@Lilly leadership and the business, identify TPO strategies that will enable the CDDA’s clinical information and automation strategy.
• Provide leadership in the setting of clear business requirements and expectations to enable identification of appropriate technology solutions by the Tech@Lilly organization.
• Lead cross‑functional initiatives.
• 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 CTF organization at appropriate internal and external venues.
• Drive shared learning and process expertise between teams within the organization.

People Management and Partnership

• If applicable, recruit, develop, and retain a scientific, technical and operationally capable workforce skilled and knowledgeable in the overall CTF organization.
• Effectively create and manage an agile organization that continuously meets the needs of a changing portfolio.
• Build an organizational culture that fosters inclusion, innovation, and promotes diversity.
• Partner closely with CDDA leadership, Tech@Lilly and other functions to effectively plan, forecast, and manage the sanctioned projects.

Minimum Qualification Requirements

• Bachelor’s degree and 5 years of experience in clinical drug development or information flow with expertise in related process, technology and information flows (clinical results and operational) such as IT, Data Sciences, Statistics, Clinical Development, Clinical Project Management and/or Quality/Regulatory.
• Demonstrated ability to set and implement strategies and plans to improve complex drug development processes and capabilities.
• Strong networking, interpersonal and relationship skills, with demonstrated ability to work in teams, across organizational boundaries and achieve results through others.
• Demonstrated credibility and ability to influence peers, management and senior leadership.
• Indianapolis based position.

Other Information/Additional Preferences

• Previous supervisory experience.
• Previous experience with system ownership, implementation of new technology, business process automation.
• Proven ability to develop and deliver both strategic and tactical plans.
• Knowledge of emerging IT capabilities for clinical research.
• Strong problem‑solving skills.
• Flexibility to adjust quickly to changing business priorities.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $156,000 - $228,800. Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day‑care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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