Rheumatology Lead, Global and US Immunology Medical Affairs.

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. 

The Medical function throughout the Lilly enterprise brings scientific objectivity, clinical expertise and experience in patient care that enhance Lilly’s R&D, but Medical Affairs extends those benefits in its interactions with the customer and uses those customer experiences to inform ongoing development and use of Lilly’s medications.

Medical Affairs (MA) plays a critical role in anticipating and interpreting the constant and rapid changes happening in the complex world of healthcare. Medical Affairs leads efforts to identify and address Clinical Care Gaps, generate evidence, and share science across communication channels. The application of scientific and medical training, clinical expertise, and relevant clinical experience, positions the Medical Affairs Clinical Research Physician (CRP) as an integral member of the medical affairs team.

The Rheumatology Lead CRP, with his team, will develop an overarching strategy to guide Lilly’s rheumatology portfolio over the next 10 years, including Early involvement in cross-functional teams to bring best-in-class, first-in-class, and meaningfully differentiated medicines to market, launch strategy and execution of new assets and indications and life-cycle management of launched medicines. This role will lead the rheumatology medical affairs team and will report to the Head of Rheumatology, Respiratory and Pipeline Global and US Medical Affairs.

The Medical Affairs CRP leads the medical strategic planning supporting launch and commercialization of our treatments. Additionally, the MA CRP leads the medical strategy addressing patients' needs and ultimately enhancing the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs), and payers. The CRP also works closely with the 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 local 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. In leading the Medical Affairs medical strategy, the CRP is responsible for appropriately informing the strategic priorities of the respective business unit global Medical Affairs team, brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase/ Clinical Pharmacology, and Translational Medicine team(s).

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 of the medical team and direct reports, 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 role/position can change over time and can include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that might be required for the role/position.

The primary responsibility of the Medical Affairs CRP is to provide expert medical leadership and support to all aspects of the local business, to ultimately enhance the customers' experience and develop medical strategies that improve patient outcomes. This includes informing the identification of Clinical Care Gaps (CCG), Integrated Evidence Generation (IEG) planning, product lifecycle planning, and evidence dissemination plans aligned with medical strategy.

The CRP provides local marketed product support (informing 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  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 affiliates/countries as described in the clinical plan. 

In addition, the CRP, if assigned, 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.

The Rheumatology Lead CRP will have a leadership role  with direct reports to collectively drive and deliver medical affairs plans for rheumatology assets/indications spanning over data generation, data dissemination, TL engagement and omnichannel and digital education supporting advance the care and outcomes of patients with rheumatological diseases with disease and asset focus approach.

Business/customer support (pre and post launch support)

• Understand and anticipate the scientific information needs of all local/regional 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 as a scientific and medical expert to activities and deliverables of the PRA organization, 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 medical representatives and sales 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 leading identification of Clinical Care Gaps (CCGs).
• Provide medical insight and training to patient support programs (for example, Diabetes Nurse Educators Service).
• Understand and apply knowledge of customer insights to all customer-related activities.
• Participate in local or national trade associations, as appropriate.
• 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.

Scientific Data Dissemination/Exchange

• Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.
• Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
• 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 local 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).
• Lead efforts in Integrated Evidence Generation (IEG) planning, participate in data analyses, development of scientific data dissemination including personal and non-personal channel strategy, and preparation of final reports and publications.
• Participate in reporting of clinical trial data in Clinical Trial Registry activities.

Clinical Planning

• Communicate and collaborate with Director-Medical and  Business  Unit Team  Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, global Medical Affairs and Development teams, Global Patient Outcomes/Real World Experience, PAA, Therapeutic Area Program Phase, and Early Phase /EPM/Translational Medicine teams.
• Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams, Global Patient Outcomes/Real World Experience, and PAA teams to ensure  Phase 3, 3b,  and 4 (and Phase I and II where applicable} clinical programs meet the needs of local/regional customers (for example, through global medical planning processes).
• Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
• Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design.

Clinical Research/Trial Execution and Support

• Review and approve local informed consent documents and risk profiles to ensure appropriate communication of   risk to study subjects.
• Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
• Collaborate with Clinical Research Scientists (CRSs), regional clinical operations staff, statisticians, health outcomes, research scientists and selected investigators in the development of protocols and data collection requirements.
• Participate in investigator identification and selection, in conjunction with clinical teams.
• Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board,  informed  consent,  regulatory  approval/notification)  consistent with Good Clinical Practices (GCPs) and local laws and requirements.
• Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel.
• Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
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