Lilly Medical Advisor (m/f/d) Global Medical Affairs in Remote, Germany
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 35,000 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 Diabetes Business Unit - Medical Affairs Alliance Medical Advisor is an integral member of the Diabetes Alliance between Boehringer-Ingelheim and Lilly 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 patients, providers (HCPs) and payers. The Medical Advisor may also work closely with global Development teams, Therapeutic Area Program Phase, and Early Phase / Clinical Pharmacology 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 and affiliate needs. In addition, with input from the Alliance Director-Medical and Business Unit Team Physician/Regional Medical Leader, the Medical Advisor is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective business unit global Medical Affairs team, Alliance team, brand team(s), global Development team, Therapeutic Area Program Phase, and Early Phase / Clinical Pharmacology teams.
The Medical Advisor serves as a scientific resource for study teams, departments, and others as needed. The Medical Advisor 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, Alliance agreement/guidance, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision.
The primary responsibility of the Diabetes Business Unit Alliance Medical Affairs Medical Advisor is to provide expert medical support to all aspects of the 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), supporting questions and needs of our affiliate medical staff, 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). The Medical Advisor is responsible for leadership that allows appropriate scientific support of the marketed product,
across the spectrum of people with diabetes. This includes, but is not limited to, design and execution of phase 4 studies and expansion of real-world evidence, observational data and patient reported outcomes to address the needs of the commercial organization.
Successful and relevant phase 4 programs must anticipate provider, patient, policy and payer questions years in advance of customer inquiries. This work will require cross-portfolio, patient-reported and observational studies aligned with therapeutic tailoring strategies. This requires in depth knowledge of diabetes, metabolism and related cardiovascular and kidney conditions (including risk factors and co-morbidities) and an in-depth understanding of global research, real world evidence, clinical and commercial needs.
Business/ customer support (pre and post launch support)
Understand and anticipate the scientific information needs of all 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 Alliance Medical Affairs and brand teams, Alliance partners, Global Patient Outcomes/Real World Evidence and global PRA, clinical management personnel and other cross-functional management during the development of the 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 global brand team.
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).
Participate in local or national trade associations, as appropriate.
Scientific Data Dissemination/Exchange
Knowledge of and compliance with laws and regulations, Alliance guidance, 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.
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 Alliance partners, external scientific experts, thought leaders, and the general medical community on an 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).
Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications.
Communicate and collaborate with Alliance Director-Medical and Business Unit Team, Physician/Regional Medical Leader as needed to ensure the life cycle plan for the product, address customer needs or communicate and collaborate such needs as delegated by Alliance Director-Medical and Business Unit Team Physician/Regional Medical Leader, as needed, global Alliance Medical Affairs and Development teams, Global Patient Outcomes/Real World Experience, PRA, 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, Alliance teams, Global Patient Outcomes/Real World Experience, and PRA 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.
Clinical Research/Trial Execution and Support
Collaborate with clinical research staff in the design, conduct and reporting of clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
Collaborate with Clinical Research Scientists (CRSs), 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.
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.
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.
Regulatory Support Activities
Participate in development and review of labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of the label.
Provide medical expertise to regulatory affairs.
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, including regulatory response, from an affiliate/country perspective.
Participate in advisory committees.
Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS).
Scientific/Technical Expertise and continued development
Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near term (1-2 years) and longer-term (3-5 years).
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.
Acts as scientific consultant and protocol expert for clinical study team members and others in medical and the Alliance.
Explore and take advantage of opportunities for extramural scientific experiences.
Attend, contribute and participate in medical congresses/scientific symposia.
Support the business unit management team, including medical leadership in preparation and administration of the Alliance medical budget.
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.
As applicable, works closely with direct reports on performance management plans (objectives), development plans, and documentation of their expertise. Keeps these documents and plans up to date. 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.
Model the leadership behaviors.
Be an ambassador of both patients, the Lilly Brand, and the BI/Lilly Alliance team
Responsibilities within the Global BI-LLY Medical Affairs Team
Take medical responsibility for launch readiness, launch and post–launch activities of empagliflozin in the therapeutic area of diabetes and/or chronic kidney disease
Provide medical expertise cross-functionally, including attendance and input at meetings of respective functions, eg GRC/global review committee, Brand team meetings etc.
Create and implement processes to optimize the medico-marketing interaction.
Develop the medical part of global brand plans in cooperation with the rest of the team and with other functions, incl. marketing. Support development of local medical affairs plans, in coordination with global medical advisors for the regions.
Provide strategic input for the marketing part.
Supervise and support execution of brand plans from a medical perspective.
Support global committees in reviewing and approving clinical studies/NIS/IIS.
Contribute to publications and provide strategic input on to the publication plan and coordinate its execution from writing through to publication, in cooperation with the publication manager as appropriate and agreed upon.
Be an active member of the Lilly global medical affairs team.
Be able to locate near or travel frequently to Ingelheim, Germany.
Minimum Qualification Requirements:
Medical Doctor. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
Pharmaceutical medicine experience.
Knowledge of drug development process is preferred.
Knowledge of/experience on diabetes and/or chronic kidney disease is preferred.
Demonstrated ability to balance scientific priorities with business priorities.
Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills
Demonstrated ability to influence others (across companies, cross-functionally and within the function) in order to create a positive working environment.
Flexibility to adjust to the ever-changing Alliance environment and effectively manage change.
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.
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