Rheumatology Lead, Global and US Immunology Medical Affairs.

Eli Lilly and Company • Us, IN

13d • Hybrid

About The Position

The Medical function at Lilly brings scientific objectivity, clinical expertise, and patient care experience to enhance R&D. Medical Affairs (MA) extends these benefits through customer interactions and uses customer experiences to inform the ongoing development and use of Lilly’s medications. MA plays a critical role in anticipating and interpreting changes in healthcare, leading efforts to identify and address Clinical Care Gaps, generate evidence, and share science across communication channels. The Rheumatology Lead, a Medical Affairs Clinical Research Physician (CRP), will develop an overarching strategy for Lilly’s rheumatology portfolio over the next 10 years. This includes early involvement in cross-functional teams to bring innovative medicines to market, leading launch strategy and execution for new assets and indications, and managing the lifecycle of launched medicines. This role reports to the Head of Rheumatology, Respiratory and Pipeline Global and US Medical Affairs. The CRP leads medical strategic planning supporting launch and commercialization, addresses patient needs, and enhances customer experience (patients, providers, payers). The CRP also collaborates with global Development teams, Therapeutic Area Program Phase, Early Phase/Clinical Pharmacology, and Translational Medicine teams throughout drug development. Specific activities include developing clinical/medical plans, conducting local clinical trials, implementing global clinical trials, reporting adverse events, reviewing protocols and publications, supporting pricing, reimbursement, and access (PRA) documents, interacting with regulatory agencies, and engaging with the external clinical customer community. The CRP informs strategic priorities of the business unit, brand teams, global Development, and other cross-functional teams. The CRP serves as a scientific resource and ensures all activities comply with regulations, GCPs, company standards, and Lilly policies.

Requirements

• Medical Doctor--must be board eligible or certified in a medical specialty relevant to the role 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.
• Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee for Medical Education (LCME).
• Minimum of 3 years of Medical Affairs or medical development experience in a pharmaceutical company.
• Demonstrated ability to balance scientific priorities with business priorities.
• Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills.
• Demonstrated ability to influence others (both cross-functionally and within the function) to create a positive working environment.
• Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
• Fluent in English, verbal, and written communication.

Nice To Haves

• Knowledge of drug development process relevant to country/region preferred.
• Clinical research or pharmaceutical medicine experience preferred.
• Rheumatology or immunology related specialty preferred.
• 5 years or more experience in pharma preferred.

Responsibilities

• Develop an overarching strategy to guide Lilly’s rheumatology portfolio over the next 10 years.
• Lead early involvement in cross-functional teams to bring best-in-class, first-in-class, and meaningfully differentiated medicines to market.
• Lead launch strategy and execution of new assets and indications.
• Manage the life-cycle of launched medicines.
• Lead the rheumatology medical affairs team.
• Lead the medical strategic planning supporting launch and commercialization of treatments.
• Lead the medical strategy addressing patients' needs and enhancing customer experience.
• Collaborate with global Development teams, Therapeutic Area Program Phase, Early Phase/Clinical Pharmacology, and Translational Medicine teams in new product development.
• Develop or contribute to global and/or regional clinical/medical plans.
• Oversee the development, conduct, and reporting of local clinical trials.
• Implement global clinical trials conducted in local affiliates/countries.
• Report adverse events as mandated by corporate patient safety.
• Review protocols, study reports, publications, and data dissemination for products.
• Support new and updated labels, documents, and tools supporting product pricing, reimbursement, and access (PRA).
• Manage grant submissions and contracts.
• Liaise with regulatory and other governmental agencies.
• Conduct outreach medical activities aimed at the external clinical customer community, including thought leaders.
• Support demand realization through various medical activities.
• Inform 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).
• Serve as a scientific resource for study teams, departments, and others.
• Ensure compliance with all current local and international regulations, laws, guidance (e.g., FDA, ICH, CPMP), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, and the Principles of Medical Research.
• Provide expert medical leadership and support to all aspects of the local business to enhance customer experience and develop medical strategies that improve patient outcomes.
• Inform the identification of Clinical Care Gaps (CCG) and Integrated Evidence Generation (IEG) planning.
• Contribute to product lifecycle planning and evidence dissemination plans aligned with medical strategy.
• Provide local marketed product support, informing the development of the 'patient journey' and strategic plan for the compound.
• Provide medical support for regulatory affairs and interactions with government agencies.
• Provide medical guidance on the PRA plan and interact with government PRA agencies.
• Lead in local scientific data dissemination, including leading and presenting at conferences and advisory boards.
• Oversee the development of the scientific content of educational programs.
• Collaborate with 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.
• Support global Development studies conducted in affiliates/countries.
• Drive and deliver medical affairs plans for rheumatology assets/indications spanning data generation, data dissemination, TL engagement, and omnichannel and digital education.
• Understand and anticipate the scientific information needs of all local/regional customers (payers, patients, health care providers).
• Actively address customer questions by leading data analyses and new clinical or health outcomes research efforts.
• Contribute as a scientific and medical expert to the PRA organization, providing clinical input and insight to develop payer partnership programs and defend product value.
• Support business-to-business and business-to-government activities as a medical expert.
• Contribute actively to the strategic planning for currently marketed brands.
• Contribute to the development, review, and approval of promotional materials.
• Support training of medical representatives and sales representatives.
• Take a leadership role in defining the Patient Journey and corresponding Moments of Truth.
• Act as a patient advocate and lead identification of Clinical Care Gaps (CCGs).
• Provide medical insight and training to patient support programs.
• Understand and apply knowledge of customer insights to all customer-related activities.
• Participate in local or national trade associations.
• Contribute to the development of medical strategies to support brand commercialization activities.
• Ensure 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.
• Actively address unsolicited scientific information needs of external health care professionals.
• Support the planning of symposia, advisory board meetings, and 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.
• Prepare or review scientific information in response to customer questions or media requests.
• Provide follow-up to information requested by health care professionals.
• Support data analysis and the development of slide sets and publications.
• Establish and maintain appropriate collaborations and relationships with external scientific experts, thought leaders, and the general medical community.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies.
• Support the design of customer research as a medical expert.
• Provide congress support.
• Lead efforts in Integrated Evidence Generation (IEG) planning.
• 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.
• Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader to ensure life cycle plans address customer needs.
• Communicate local/regional research needs and collaborate with other regions and global teams to ensure clinical programs meet local/regional customer needs.
• Understand and keep updated with 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.
• Review and approve local informed consent documents and risk profiles.
• Collaborate with clinical research staff in the design, conduct, and reporting of local clinical trials.
• 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.
• Ensure that the clinical operations team has documented the completion of administrative requirements for study initiation and conduct.
• Assist in the planning process and participate in study start-up meetings to provide scientific training and information to investigators and site personnel.
• Serve as a resource to clinical research site monitors, investigators, and ethical review boards.
• Review IIT proposals and publications, as requested.
• Contribute to global alignment of Phase 3b/4 clinical studies (and Phase I and II studies where applicable) planned by country(ies) or global Development team.
• Understand and actively address the scientific information needs of all investigators and personnel.
• Monitor patient safety during the conduct of studies and conduct tracking and follow-up of adverse events.
• Participate in development and review of local labeling and labeling modifications.
• Demonstrate deep knowledge of local label.
• Support/assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues.
• Participate in advisory committees.
• Provide medical expertise to regulatory scientists.
• Participate in risk management planning.
• Be aware of current trends and projections for clinical practice and access in the therapeutic area(s).
• Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments.
• Responsible for the scientific training of the clinical study team.
• Act as scientific consultant and protocol expert for clinical study team members and others.
• Explore and take advantage of opportunities for extramural scientific experiences.
• Attend, contribute, and participate in medical congresses/scientific symposia.
• Lead, develop, and coach direct reports.
• Support recruitment of new team members and their development.
• Support the business unit management team in preparation and administration of the local or business unit medical budget.
• Use knowledge of specific disease states and available treatments to provide scientific and medical input.
• Contribute to the development, review, and approval of promotional and medical materials ensuring high integrity and quality.
• Actively set and meet individual professional development goals.
• Contribute to the development of others by being an active source of coaching and feedback.
• Collaborate proactively and productively with all alliance, business, and vendor partners.
• Provide timely and constructive feedback to co-workers and direct reports.
• Work closely with direct reports on performance management plans, development plans, and documentation of their expertise.
• Meet regularly with each direct report to coach, mentor, evaluate performance, and monitor career development goals.
• Maximize each individual direct report's career potential.
• Actively participate in recruitment, diversity, and retention efforts.
• Participate in committees, Six Sigma initiatives, and task forces as requested.
• Model leadership behaviors.
• Be an ambassador of both patients and the Lilly Brand.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree