Associate Director - Clinical Research Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work, but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

About Lilly

At Lilly, everything we do starts with patients.

We unite caring with discovery to make life better for people around the world.

Headquartered in Indianapolis, Indiana, our global team of over 50,000 employees work with urgency and purpose to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

We bring our best to this work because people depend on it.

If you’re driven by purpose and determined to make a meaningful difference for patients, we invite you to bring your skill and your commitment to Lilly.

About Lilly’s India Affiliate

Few careers offer the opportunity to work directly for the people your work is ultimately meant to serve.

Lilly’s India affiliate is one of them.

Whether you are building brand strategies, developing sales capabilities, creating market access, or enabling the teams that do, the work you do here ensures that Lilly’s medicines reach the people who need them.

Job Description

The Clinical Development Consultant (CRL) is responsible for the management of clinical sites being considered and/or participating in Lilly clinical trials; inclusive of site identification and qualification, the timely delivery of clinical trial enrollment in accordance with scientific objectives, timely delivery of database locks, issues management at clinical trial sites, and ensuring inspection readiness at all times for assigned therapeutic area(s) within a region/country that enables global program delivery. This is achieved by the CRL’s accountability for comprehensive site management, leveraging of information/tools to make/have informed decisions and discussions, and high-quality interactions with global clinical trial sites to drive to an unparallel customer experience. The CRL is also responsible for oversight of vendor monitoring activities at clinical trial sites, including the identification, mitigation and escalation of significant findings and trends. Additional local responsibilities may be required as needed/appropriate for the local geography.

Clinical Investigator Management

Accountable for activities required at clinical trial sites and by investigators and site staff participating in Lilly trials; inclusive of site identification and qualification, enrollment planning and execution, to database lock and close out

Accountable for comprehensive site management activities to ensure timely delivery of enrollment readiness, trial recruitment/enrollment and database locks; inclusive of performance management and issue mitigation, identification and resolution

Responsible for identifying potential opportunities to accelerate trial enrollment, while driving to an unparalleled clinical trial/customer experience

Accountable for the application of scientific, therapeutic area, and institutional/regional expertise to inform and ensure timely delivery of trial enrollment and quality data

Accountable for the development of strategic institutional/site relationships to optimize the delivery of clinical trial programs; including across therapeutic areas where applicable

Clinical Trial Management

Responsible for the development and implementation of applicable site risk plans to ensure delivery of clinical trial enrollment commitments and database locks

Ensure site and country level inspection readiness at all times

Leverage metrics to inform site/country/regional level decision making

Work with internal and external teams to remove barriers to trial execution at a site and/or country level

Responsible for understanding local treatment paradigms and standard of care to support targeted feasibility and strategic allocation of trials as required

Provide vendor oversight for site monitoring activities at site/country level

Business Management and Engagement

Establishes and develops strong professional relationships with active/potential clinical investigators to expand/maintain clinical research partnership opportunities and provide an unparalleled experience for participation in Lilly clinical trials

Cross functional collaboration and partnership to ensure alignment in priorities and deliver the portfolio

Perform targeted sites prospecting in alignment with portfolio strategy & priority

Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel

Serve as an effective communication ‘bridge’ between sites, third party vendors and Lilly

Influence and challenge internal and external factors in order to improve clinical research delivery

Minimum Qualification Requirements

Bachelor’s degree or equivalent

Minimum of 8–10 years’ experience in the pharmaceutical industry and/or clinical research and strong working knowledge of Good Clinical Practice

Therapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain therapeutic expertise to support portfolio needs

Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed

Demonstrated strategic agility & broad business acumen

Demonstrated leadership behaviours with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty

Other Information / Additional Preferences

Strong preference for bachelor’s degree in scientific or health-related field

Strong communication (both verbal and written) and language skills

Strong organizational/planning skills

Demonstrated ability to enhance/improve customer experience

Fluent in English as well as required language to conduct day-to-day business

Strong knowledge in country regulatory guidelines/requirements

Strong teamwork and interpersonal skills

Demonstrated decision-making ability

Ability to develop and apply creative solutions

Travel required (50–75%)

At Lilly, caring is not only what we do for patients.

It is how we work.

We believe the people who dedicate themselves to making medicines better deserve an environment that makes their lives better too, one where they are supported, respected, and given the space to do their best work.

This is not just a policy.

It is who we are.

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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