Executive Medical Director, CardioRenal

Eli Lilly and Company; Boston (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

Eli Lilly and Company in the United States seeks an Executive Director to lead clinical development for cardio-renal therapies. You will oversee trial design, collaborate with preclinical teams, and drive strategies across all development phases to deliver medicines that improve patient outcomes.

The role requires interaction with regulators and external experts, supervision of global trials, and ensuring compliance with GCPs and guidelines.

Responsibilities

• Collaborate with Preclinical groups, Clinical Pharmacology, Health Outcomes in development of Draft Launch Labels and Value Propositions.

Job description

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.

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. 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. He/She 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 clinical 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. He/She 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