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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
198,000 - $330,000
Purpose :
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Diabetes and Obesity Business Unit – Global Medical Affairs 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 Diabetes and Obesity 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 non clinical 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)
Clinical Planning
Regulatory Support Activities
General Responsibilities
Minimum Qualification Requirements :
Medical Doctor Must be board eligible or certified in a medical specialty in Endocrinology or Diabetology or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. U.S. trained physicians must have achieved board eligibility or certification. Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
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 an EEO / Affirmative Action Employer and 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.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include : Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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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