Rheumatology Lead, Global and US Immunology Medical Affairs.

Lilly • Indianapolis, IN

4d • $265,500 - $420,200 • Onsite

About The Position

The Medical function at Lilly brings scientific objectivity, clinical expertise, and patient care experience to enhance R&D. Medical Affairs extends these benefits through customer interactions and uses customer experiences to inform the ongoing development and use of Lilly’s medications. Medical Affairs (MA) plays a critical role in anticipating and interpreting changes in healthcare. MA leads efforts to identify and address Clinical Care Gaps, generate evidence, and share science across communication channels. The Rheumatology Lead, with their team, 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 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 report to the Head of Rheumatology, Respiratory and Pipeline Global and US Medical Affairs. The Medical Affairs CRP leads medical strategic planning supporting launch and commercialization of treatments, addresses patient needs, and enhances customer experience. The CRP also works closely with global Development teams, Therapeutic Area Program Phase, Early Phase/Clinical Pharmacology, and Translational Medicine teams in new product development activities. Specific activities include developing or contributing to the global and/or regional clinical/medical plan, development, conduct and reporting of local clinical trials, implementation of global clinical trials in local affiliates/countries, reporting adverse events, review of protocols, study reports, publications and data dissemination, 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, outreach medical activities aimed at the external clinical customer community, and medical activities in support of demand realization. The CRP is responsible for 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 and ensures all activities comply with regulations, GCPs, company standards, and Lilly policies. The primary responsibility is to provide expert medical leadership and support to enhance customer experience and develop medical strategies that improve patient outcomes, including informing Clinical Care Gap identification, Integrated Evidence Generation planning, product lifecycle planning, and evidence dissemination plans. The CRP provides local marketed product support, medical support for regulatory affairs and government agency interactions, medical support for pricing, reimbursement, and access (PRA), and leads local scientific data dissemination. These responsibilities generally relate to late phase and marketed compounds but can include early phase trials. The CRP collaborates with global teams in planning, startup, and conduct of phase 3b/4 studies and non-clinical trial solutions/activities. The Rheumatology Lead CRP will have a leadership role with direct reports to drive and deliver medical affairs plans for rheumatology assets/indications, spanning data generation, data dissemination, TL engagement, and omnichannel and digital education.

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 on 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.
• 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

• 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), Integrated Evidence Generation (IEG) planning, product lifecycle planning, and evidence dissemination plans aligned with medical strategy.
• Provide local marketed product support, including informing the development of the "patient journey" and the strategic plan for the compound.
• Provide medical support for regulatory affairs and interactions with government agencies, including medical support for New and Supplemental New Drug Submissions and participating in meetings with regulatory agencies.
• Provide medical support for pricing, reimbursement, and access (PRA), including providing medical guidance on the PRA plan and interacting with government PRA agencies.
• Lead in local scientific data dissemination, including leading and presenting at conferences, advisory boards, and overseeing 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 of 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 (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.
• Offer scientific and creative input 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 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.
• 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.
• 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.
• Support the planning of symposia, advisory board meetings, 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.
• Develop and maintain appropriate collaborations and relationships with relevant professional societies.
• Support the design of customer research as medical expert.
• Provide congress support (e.g., 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.
• 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.
• Communicate local/regional research needs and collaborate with other regions and the global Development and Medical Affairs teams to ensure Phase 3, 3b, and 4 (and Phase I and II where applicable) clinical programs meet the needs of local/regional customers.
• 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.
• 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.
• 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.
• 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.
• 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 the appropriate tracking and follow-up of adverse events.
• Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal.
• 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) relevant to the product.
• 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 relevant to the product.
• Responsible for the scientific training of the clinical study team.
• Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
• 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.
• Supports recruitment of new team members and their development.
• Support the business unit management team, including medical leadership 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 and contribute to the development of others by being an active source of coaching and feedback to co-workers, and direct reports as applicable.
• Collaborate proactively and productively with all alliance, business, and vendor partners.
• Participates in active coaching by providing timely and constructive feedback to co-workers, others on the clinical medical team, in the spirit of development, increased team effectiveness and cohesiveness.
• Works closely with direct reports on performance management plans (objectives), development plans, and documentation of their expertise.
• Meets regularly with each direct report to coach, mentor, evaluate performance, evaluate training and development needs, and monitor career development goals.
• Maximizes each individual direct report's career potential, maximizing the value to the organization.
• Actively participate in recruitment, diversity, and retention efforts, and hiring efforts as applicable.
• Participate in committees, Six Sigma initiatives and task forces as requested by business unit/corporate management.
• Model the 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