Visiting Scientist Fellowship OpportunitiesClinical Trial Management (2 Positions)
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Leads cross-functional study teams in development and implementation of clinical trials worldwide
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Manages all aspects of clinical development from protocol development to final study report completion
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Accountable for ensuring data integrity and patient safety is delivered throughout clinical trials
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Manages activities utilizing critical chain methodology to ensure delivery of clinical trials on time and within budget. Clinical Trial Material Manufacturing and Services (CTMMS) Project ManagementAccountable for providing project management leadership within Global Clinical Trial Material Manufacturing and Services. Specifically:
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Learning the application and integration of key project management processes and tools across teams and/or projects to deliver clinical trial material with quality, on time, on budget and within scope
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Leads the CTMMS team to deliver the right drug to the right patient at the right time
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Partners with cross-functional team (other functional project managers) to drive development and delivery of global, integrated CTMMS plan deliverables while ensuring their alignment with the global clinical strategy
- Manages upward and cross-functional communication, anticipates risks and mitigation strategies with the team while keeping the asset and portfolio in mind, ensures documentation of key team/asset information and decisions, and ensures project management systems are up to date.
Regulatory Affairs: Promotional Materials
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Understands the FDA regulations and guidance documents and how they apply to advertising and promotion
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Attends US brand team meetings regularly and actively participates in making recommendations regarding proposed promotional activity plans
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Stays apprised of the external environment related to promotion and advertising and potential ramifications on the pharmaceutical industry. Regulatory Affairs: Regulatory IntelligenceIntelligence paired with the scientists’ best insights drive the regulatory strategy for each molecule, from candidate selection through post-approval, in the Lilly Research Laboratories around drug development. The Regulatory Intelligence Center of Excellence functions with the strategic intent to combine intelligence of the external regulatory and business environment with experiential learning extracted from our operational systems. The regulatory intelligence fellow is expected to:
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Define, gather, analyze, and transform relevant information into useful, applicable, actionable output used to drive efficient and effective decision making
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Stay apprised of the external regulatory and business environment and use the information to strategically predict and manage regulatory risk and opportunities
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Understand US regulations and guidance documents and how they apply to the drug development process. Regulatory Affairs: Regulatory Registration
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Demonstrates knowledge and understanding of regulations and guidances and how they apply to regulatory registrations.
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Demonstrates knowledge of the drug development process to build robust registration plans, and to influence teams regarding registration applications.
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Owns the operational aspects of the regulatory registration for the lifecycle of the registration record. Partners with the regulatory scientist to proactively manage the registration application content
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Demonstrates and applies deep understanding of regulations and guidances for compliance submissions.
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Leads registration application planning and execution to ensure meeting regulations while meeting team needs.
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Influence and partner within GRA and cross-functionally to ensure operational consistency while meeting team needs. Regulatory Affairs: Regulatory Policy and IntelligenceThis is a split role between US Regulatory Policy and International Regulatory Policy and Intelligence. Key activities include the following:
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Identifying and assessing external regulatory trends that pose opportunities or threats for the pharmaceutical industry
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Developing Lilly positions on key regulatory policy issues and advocating for policy change in the US, Europe, and other countries
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Cultivating opportunities to engage in industry associations and other multistakeholder coalitions to achieve shared regulatory policy objectives
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Evolving regulatory intelligence capabilities for several emerging market countries
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Contributing to briefings and updates for Lilly senior leadership and other colleagues. Global Health Outcomes: Business Unit Platform Scientist
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Provides scientific methodological and conceptual expertise to assist in the development and commercialization of a product and ensure successful fulfillment of health outcomes research plans to deliver better outcomes that are valued by payers, healthcare professionals and patients
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Focuses on diseases and/or treatments that Lilly is developing within a specific therapeutic area and which span the entire lifecycle of product development and commercialization
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Provides scientific study design support and strategy input to medical and commercial functions
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Projects may focus on key healthcare policy issues, economic outcomes, patient-reported outcomes, clinical outcomes, therapeutic utilization, and other topics that may impact health and healthcare. Global Health Outcomes: US Health Technology Assessment
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Serves as scientific and strategic interface between the health outcomes research groups, outcomes liaisons communication function and marketing/managed markets partners to support the US payer market
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Accountable for understanding, anticipating, and influencing evidence thresholds across different payer segments/HTA bodies in the US to secure and maintain formulary access/ reimbursement for Lilly products
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Informs, influences, conducts, and/or packages health outcomes studies for Lilly commercialized and pipeline products that meet the information needs of US payers. Global Health Outcomes: US Outcomes LiaisonLilly’s Global Health Outcomes (GHO) function strives to demonstrate the economic, clinical, and humanistic value of our medicines to global payers, patients, and providers with timely and relevant scientific evidence. The outcomes liaisons are the scientific interface between GHO and US decision-makers involved in product positioning, selection, and access.
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Serves as internal partner to and collaborates with field-based outcomes liaison team to meet the needs of external decision makers.
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Acquires and maintains significant scientific and disease state knowledge, including an understanding of the competitive environment.
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Supports GHO and the US affiliate by providing medical and health outcomes information in assigned product and therapeutic areas to internal and external customers.
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Demonstrates leadership through knowledge sharing, process improvement, and identification of needs as they pertain to primary responsibilities. Global Pricing, Reimbursement and Access: New Product Planning
The GPRA-NPP team is responsible for:
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Developing exceptional understanding of payer’s needs in key markets from a macro-environmental level and for specific diseases and medicines
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Working with its business partners to represent these payer requirements to inform the commercial strategy, the forecast and the clinical development program of medicines within the pipeline, with a particular focus on medicines in Phase 2 to the time when the medicine enters Phase 3 development.
The visiting scientist will work on a number of therapeutic areas in the pipeline and will apply scientific expertise in a commercial role. By the end of the program they will have participated in market research and advisory boards, gained knowledge on how key markets make PRA decisions and analyzed and made recommendations on opportunities for pipeline medicines and how to optimize patient’s access to these treatments. Global Public Policy
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Through research, analysis, collaboration, and engagement, Global Public Policy develops well-reasoned positions and sound information to help Lilly shape health policy in ways that support improved patient outcomes and continued incentives for investment in biopharmaceutical innovation.
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Policy issues of focus include health technology assessment, regulatory reforms, and health benefits design.
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Working cross-functionally, the policy team applies scientific knowledge to legislative policy analysis in order to develop new policy solutions and advocate for policy changes. Project Management
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Partners with cross-functional team and program team leader to coordinate creation of an integrated drug development plan. The project manager has routine interactions with individuals from clinical, Chemistry/Manufacturing/Control, toxicology, ADME, regulatory, health outcomes, legal, discovery and marketing
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Impacts drug development strategy as relates to the project timeline, scope, budget, and risk in accordance with the “label as driver” concept
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Acquires necessary project management skills to facilitate delivery of team milestones on time, on budget, and within scope for several early phase drug development teams in various therapeutic areas
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Manages cross-functional communications, documents key team information and decisions, and ensures project management systems are accurate and up to date
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Demonstrates leadership with regard to sharing learning, process improvement, and identification of special/complex needs as they pertain to primary responsibilities. Global Patient Safety: Clinical Research ScientistThe Global Patient Safety-Medical function provides medical leadership and input into all aspects of safety of Lilly products including surveillance programs and risk management. The clinical research physician/scientist is expected to:
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Understand the process and regulations for adverse events reporting and drug safety in clinical development as well as post-marketing
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Lead and guide the safety surveillance activities of scientists on the team including signal detection and clarification activities and risk evaluation activities
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Provide medical expertise in safety risk management activities
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Manage decision and actions to be taken in order to demonstrate a positive benefit-risk balance for Lilly products. |
