Lilly Clinical Research Scientist | Medical Director Diabetes in Ontario, Canada
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.
Clinical Research Scientist | Medical Director Diabetes
Location: Head office
Eli Lilly Canada is currently searching for Clinical Research Scientist for the Diabetes Business Unit.
At Lilly, we’re, inspired to make a difference in people’s lives every day – through the discovery of life-changing medicines, better understanding of disease management and support for people living with illness and their families and friends.
Our work today – from our research programs to our volunteer initiatives – is a reflection of our heritage of uniting caring with discovery to make life better for people around the world.
We are committed to investing in our employees – through competitive salaries, training and development, health, and the opportunity to make life better. The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable people to help us accomplish our mission.
Core Job Responsibilities:
Through the application of scientific and clinical training and expertise, the Clinical Research Scientist (CRS) is an integral member of the medical affairs, development or a business unit brand team for strategic planning in the support of launch activities to meet patients' needs and ultimately enhance the customers' (patients, HCPs and payers) experience in interacting with the company. The primary responsibility of the Diabetes Medical Affairs CRS/CRP is to provide expert scientific and clinical support to all aspects of the local business, to ultimately enhance the customers' experience in interacting with the company.
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 (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 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 clinical 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.
Provide medical insight and training to patient support programs.
Understand and apply knowledge of customer insights to all customer-related activities.
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).
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 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, to global Medical Affairs and Development teams, Global Patient Outcomes/Real World Evidence, 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, Global Patient Outcomes/Real World Evidence, 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.
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 staff, regional clinical operations staff, statisticians, global patient 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.
Review lIT 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 and Medical Affairs teams.
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, in alignment with corporate patient safety policies and procedures.
Regulatory Support Activities
Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal. Demonstrate deep knowledge of local label. Provide medical expertise to regulatory scientists.
Support I 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.
Responsible for the scientific training of the clinical and medical science liaisons.
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.
Support the business unit management team, including medical leadership in preparation and administration of the local or business unit 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 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.
Minimum Qualification Requirements: CRS
Advanced degree in health sciences (PhD, Pharm D) with 2-3 years of relevant clinical or therapeutic experience in diabetes preferred OR
MSc in health care/professional designation (BScN, PT, RD etc.) considered if 5 or more years of relevant clinical experience in diabetes
Preference given to individuals meeting the above with previous MSL experience in the field of diabetes and sound knowledge of the pharmaceutical industry
Intellectual curiosity and intelligence about the field of diabetes
Ability to critically appraise scientific information / literature
Strong presentation skills including the ability to comprehend large amounts of scientific content which is then communicated in a clear, concise fashion
Fluent in English for written and verbal communication
Demonstrated ability to build strong/collaborative peer-to-peer relationships with external customers
Familiarity with the academic community and medical research
Significant direct experience in servicing customer needs for complex information
Experience in professional networking with positive mutually beneficial outcomes
Strong collaborative and interpersonal skills including an ability to work effectively with internal colleagues, cross-functional team members, and external partners (co-promotions with other companies)
Strong project management skills with an ability to work within teams to prioritize key projects and medical tactics
Significant clinical or research work in the area of diabetes
French English bilingual
Existing relationships with Scientific Experts in the field of diabetes
Located in Ontario
Minimum Qualification Requirements: CRP
Medical Doctor or Doctor of Osteopathy. 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
Preference given to individuals meeting the above with previous documented expertise in the field of diabetes and sound knowledge of the pharmaceutical industry
All new employees are required to be fully vaccinated against COVID-19 as a condition of being hired by Lilly as described Lilly’s Covid-19 Vaccination Policy. The requirement to be vaccinated is inclusive of any approved boosters, should they be deemed necessary in the future. Deadlines for boosters will be communicated through an updated policy as needed.
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