Sr. Director (Medical) Oral Therapies

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.

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Business Unit- Medical Affairs Clinical Research Physician (CRP) is an integral member of the medical affairs, development or a business unit brand 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 providers (HCPs) and payers. Specific activities include developing or contributing to the medical plan in his / her therapeutic area of responsibility, supporting the development, conduct and reporting of local clinical trials; 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. In addition, with input from the Director-Medical and Business Unit Team Physician / Regional Medical Leader, the CRP is responsible for assuring that his / her activities are clearly aligned with the strategic priorities of the respective business unit global Medical Affairs team, brand team(s), global Development team, Therapeutic Area Program Phase.

The Clinical Research Physician serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Physician is aware of and ensures that all activities in medical affairs 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

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

The primary responsibility of the Business Unit - Medical Affairs CRP is to provide expert medical support to all aspects of the local business, to ultimately enhance the customers' experience in interacting with the company. This includes local 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 Cofepris, if necessary (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 local 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 CRP is responsible for collaborating with the global teams in the planning, startup and conduct of phase 3b / 4 studies (and phase I and II studies where applicable), as well as non clinical trial solutions / activities that are conducted in the affiliates as described in the clinical plan. In addition, the CRP, if assigned by the Director Medical and / or Regional Medical Leader, is responsible for support of global Development studies conducted in affiliates / countries. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.

Business / Customer Support (core and post launch support)

• Understand and anticipate the scientific information needs of all local customers (payers, patients, health care providers)
• Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.
• Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient Outcomes / Real World Evidence and global PRA, clinical management or personnel and other cross-functional management during the development of the local business plan.
• Contribute as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.
• Support business-to-business and business-to-government activities as medical expert.
• Contribute actively on an ongoing basis to the strategic planning for currently marketed brands.
• By offering scientific and creative input, contribute to the development, review, and approval of promotional materials for the brand team.
• Support training of sales representatives, and other medical representatives.
• Become familiar with market archetypes and potential influence on the medical interventions for the product.
• Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his / her medical knowledge. Become patient advocate, as well as a medical expert.
• Understand and apply knowledge of customer insights to all customer-related activities.
• Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service).

Scientific Data Dissemination / Exchange

Clinical Planning

Clinical Research / Trial Execution and Support

Regulatory Support Activities

Scientific & Technical Expertise and Continued Development

General Responsibilities

Launch Support

Key Skills / Requirements

Key Responsibilities

Scientific Platform / Communications Strategy / SOD 3b / 4 studies and their supportive study plans Training and education Internal (molecule, MOA, disease state) External (Disease State) Global Thought Leader plans - in close collaboration with regions and affiliates

Minimum Qualification Requirements

Other Information / Additional Preferences

OTHER INFORMATION

Primary Internal Interactions

External Contacts

The selected candidate should have immediate start availability.

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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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