Lilly Clinical Research Scientist, Global Medical Affairs - Thoracic Oncology in Indianapolis, Indiana
Title Clinical Research Scientist, Global Medical Affairs - Thoracic Oncology
State / Province Indiana
Workplace Arrangement Local
Company Overview 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 39,000 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.
Responsibilities The CRS is an integral member of an Global Product Team for strategic planning in the support of launch and commercialization activities. The CRS may also work closely with global Development, Therapeutic Area Program Phase, Early Phase / Exploratory Program Medicine (EPM), and Translational Medicine team(s) in new product development activities over the entire spectrum of drug development and clinical trial phases. Through application of scientific training, clinical expertise and relevant experience, the Global Oncology Business Unit Medical Affairs clinical research scientist participates in: the 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, Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility. In addition, with input from the Product Medical Director and Medical affairs leadership the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective Medical Affairs business unit brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase / Clinical Pharmacology, and Translational Medicine team(s).
The Clinical Research Scientist serves as a scientific resource for cross-functional teams, study teams, commercial, regulatory, legal departments, and others as needed.
The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidances (e.g. FDA, ICH, etc.), Good Clinical Practices (GCPs), company standards, CIA agreement, Lilly policies and procedures, and the strategic vision for Medical Affairs.
Core Job Responsibilities
The primary responsibility of the Business Unit- Global Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the business, to ultimately enhance the customers’ experience in interacting with the company. This includes launch planning global marketed product support . Specifically, the Medical Affairs CRS will support the Global Medical Affairs Lead in the development and execution of launch support programs including but not limited to: leading the scientific competitive landscape analysis, creating a scientific platform development and communications plans, scientific disaseas state educational strategy, developing and leading content and execution of internal medical training. 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 core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.
The core job responsibilities may include those listed below as well as other duties as assigned.
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.
Understand the local/regional researchneeds and collaborate with the regions to ensure their needs are defined in Global clinical development programs,Global Patient Outcomes/Real World Evidence, and PRA team plans (through relevant brand planning processes) Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
Regulatory Support Activities
May 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.
May 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 affiliate medical teams 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.
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.
Business/ customer support (pre and post launch support)
Scientific Data Dissemination/Exchange
- An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and prioprity will be if candidate has the following:
- 1 - 4+ years of pharmaceutical experience (>1 of which is in oncology medical affairs / medical communication -or- oncology/thoracic field work)
Excellent scienitific communication, medical writing, interpersonal, teamwork, organizational and negotiation skills
Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
Demonstrated ability to influence others (both cross-functionally and within the function) in order 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
- Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Primary internal interactions include, but not limited to:
Therapeutic area directors, managers, or project managers
Product directors, managers, and associates of the brand
Clinical research staff
Scientific communication associates
Medical information associates
Global patient outcomes research consultants/research scientists and health outcomes liaisons
Regulatory directors, scientists, and associates
Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical.
Corporate or regional patient safety physician(s)
Scientific and clinical experts, thought leaders
Lilly clinical investigators
Regulatory agency personnel
Professional association staff and leaders
Disease advocates and lay organizations focused on relevant health issues
Formulary representatives (private and government)
Removal Date 16-Sep-2017