Executive Medical Director - Cardio-Renal

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.

PURPOSE OF THE JOB

Lilly has innovated in diabetes care since 1923, when we introduced the world's first commercial insulin. We are currently building upon this heritage by working to meet the diverse needs of people with diabetes, obesity, and complications. Through research, collaboration and quality manufacturing we strive to make life better for people impacted by these diseases and those who care for them. Today, Lilly aims to become the next leader in cardiovascular and renal diseases.  We are looking for physician / scientists to provide clinical development leadership to a rapidly expanding cardio-renal portfolio.

The Executive Director will report to the Senior Vice President of Cardio-Renal Research and Early Clinical Development and should have broad scientific expertise in cardiovascular diseases.  Additional experience in renal diseases is a bonus.  They should have a demonstrated track record of developing clinical development strategies and trials in various diseases including, but not limited to, heart failure, ASCVD, hypertension, pulmonary hypertension, and / or CKD. The Executive Director; leveraging her / his scientific training, clinical expertise, and relevant experience; will work with preclinical teams to develop sound preclinical strategies to progress molecules to first-in-human trials and develop sound clincal development strategies and trials across all phases of development consistent with best clinical practices.  She / He will conduct and support clinical trials in each phase of development. She / He will support commercial decision for compounds in various disease states in other therapeutic indications as determined by Cardio-Renal and DOCTA management.  The Executive Director will also supervise the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications, regulatory submissions and data dissemination.  The Executive Director will take a leadership role in interactions with regulatory bodies worldwide and other governmental agencies as needed to advance the clinical development.  They will also engage external medical and scientific experts as needed to represent Lilly and to engage them in the development of molecules and implementation of clinical trials.

The Executive Director must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research.

Core Job Responsibilities

The core job responsibilities include those listed below as well as all other duties as assigned.

Clinical Planning

• Collaborate with the Preclinical groups, Clinical Pharmacology, Health Outcomes and New Product Planning in the development and maintenance of Draft Launch Labels and Value Propositions that address key customer needs (patient, provider, and payer); are consistent with known biological characteristics and effects of the molecule; consider all appropriate clinical strategies, development plans and study protocol designs.
• Contribute to global alignment of clinical strategy and clinical plans with business unit and LRL priorities.
• Understand and keep updated with the pre-clinical and clinical data relevant to molecules
• Represent Lilly in external forums where standards, common protocols, assessment instruments, regulatory standards and clinical guidelines concerning drug development

Clinical Research / Trial Execution and Support

Scientific Data Dissemination / Exchange

Regulatory Support Activities

Business / customer support (pre and post launch support)

Scientific / Technical Expertise and continued development

General Responsibilities

Basic Qualifications :

Additional Skills / Preferences :

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

$198,000 - $336,600

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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