Senior Director Global Medical Affairs (Cardiovascular / Cardiometabolic Health)

JOB DESCRIPTION

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 :

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Cardiovascular / Cardiometabolic Business Unit – Global Medical Affairs Clinical Research Physician (CRP) Senior / Executive Director is an integral member of the medical affairs team for strategic planning in the support of launch and commercialization activities to meet patients’ needs and ultimately enhance the customers’ experience in interacting with the company.   The definition of “customer” here includes patients, providers (HCPs) and payers. The Senior / Executive Director may also work closely with global Development teams, Therapeutic Area Program Phase, Early Phase  / Clinical Pharmacology, and Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical trial phases.  Specific activities include  developing or contributing to the global and / or regional clinical / medical  plan in his / her therapeutic area of responsibility, the development, conduct and reporting of clinical trials; the implementation of global clinical trials conducted in local affiliates / countries; the reporting of adverse events as mandated by corporate patient safety; review process for protocols, study reports, publications and data dissemination for products; new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization.

The Senior / Executive Director serves as a scientific resource for study teams, departments, and others as needed.  The Senior / Executive Director is aware of and ensures that all activities of the medical team  (and direct reports, if applicable)  are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision.

Primary Responsibilities :

The primary responsibility of the Cardiometabolic Health Business Unit - Medical Affairs Senior / Executive Director is to provide expert medical support to all aspects of the local / global business, to ultimately enhance the customers’ experience in interacting with the company. This includes marketed product support (participate in the development of the “patient journey” and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for New and Supplemental New Drug Submissions and participating and presenting at meetings with government regulatory agencies), medical support for pricing, reimbursement and access(PRA) (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), and leading in scientific data dissemination (leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late-phase and marketed compounds but can also include early phase trials (for example, phase I and II trials). The Senior / Executive Director is responsible for the planning, startup and conduct of phase 3b / 4 studies, as well as nonclinical trial solutions / activities that are conducted in the global team in affiliates / countries as described in the clinical plan. With the expansion of the Lilly portfolio, this role will be responsible for leadership that allows appropriate scientific support for incretins family within the portfolio and across the spectrum of patients with obesity. This includes, but is not limited to, design and execution of phase 3b / 4 studies and expansion of real-world evidence, observational data and patient reported outcomes to address the needs of the commercial organization.

Business / customer support (pre and post launch support)

• Support the planning of symposia, advisory board meetings, and and / or the facilitation of other meetings with health care professionals.
• Support medical information associates in preparation and review of medical letters and other medical information materials.
• Support training of medical personnel, including medical and / or outcome liaisons and health outcomes staff.
• Prepare or review scientific information in response to customer questions or media requests.
• Provide follow-up to information requested by health care professionals as per global SOPs.
• Support data analysis and the development of slide sets (through reviewing and / or approving) and publications (abstracts, posters, manuscripts).
• Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies.
• Support the design of customer research as medical expert.
• Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).
• Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications.
• Participate in reporting of clinical trial data in Clinical Trial Registry activities.

Clinical Planning

Regulatory Support Activities

General Responsibilities

Minimum Qualification Requirements :

Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty / subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification. Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.

Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see

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 (

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 - $356,400

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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