Visiting Scientist Fellowship

Visiting Scientist

The Visiting Scientist Fellowship is a one-year, postgraduate program that introduces participants to various medical, marketing, and regulatory aspects of the pharmaceutical industry. It is designed to train professionals for a career in the pharmaceutical industry by allowing them "hands-on" experience with the drug development process. The visiting scientist fellow is assigned to one department, yet has continuous contact with other functional areas.

Visiting Scientist Fellowship Opportunities

Global Patient Outcomes & Real World Evidence: US Outcomes Liaison

Lilly’s Global Patient Outcomes & Real World Evidence (GPORWE) 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 GPORWE and US decision-makers involved in product positioning, selection, and access. The Visiting Scientist Fellow will:

  • Serve as internal partner to and collaborate with field-based outcomes liaison team to meet the needs of external decision makers
  • Acquire and maintain significant scientific and disease state knowledge, including an understanding of the competitive environment
  • Support GPORWE and the US affiliate by providing medical and health outcomes information in assigned product and therapeutic areas to internal and external customers
  • Demonstrate leadership through knowledge sharing, process improvement, and identification of needs as they pertain to primary responsibilities.

Global Patient Outcomes & Real World Evidence: US Health Outcomes & Health Technology Assessment

The Visiting Scientist Fellow will:

  • Serve 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
  • Be 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
  • Inform, influence, conduct, and/or package health outcomes studies for Lilly commercialized and pipeline products that meet the information needs of US payers.

Global Patient Outcomes & Real World Evidence: Center of Expertise

The Visiting Scientist Fellow will:

  • Provide scientific expertise and effective project oversight to ensure successful fulfillment of outcomes and real world evidence research agendas to deliver better patient outcomes that are valued by payers and providers
  • Focus on diseases and/or treatments that Lilly is developing and which span the entire lifecycle of product development and commercialization
  • Be responsible for the conduct, quality, and integrity of outcomes and real world evidence studies and scientific disclosures resulting from this research
  • Demonstrate and apply in-depth knowledge, understanding, and evaluation of clinical, economic, and/or patient reported outcomes methodologies
  • Support projects focusing on key healthcare policy issues that impact patient outcomes

Regulatory Affairs: Regulatory Intelligence

Intelligence paired with the scientists’ best insights drive the regulatory strategy for each molecule, from candidate selection through post-approval. 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 Visiting Scientist Fellow will:

  • Define, gather, analyze, and transform relevant information into useful, applicable, actionable output used to drive efficient and effective decision making
  • Stay apprised of the external regulatory and business environment and use the information to strategically predict and manage regulatory risk and opportunities
  • Understand US regulations and guidance documents and how they apply to the drug development process
  • Research, create, develop and provide training on targeted regulatory intelligence tools to increase speed, value and quality of regulatory intelligence information that support the regulatory strategy

Regulatory Affairs: Regulatory Registration

The Visiting Scientist Fellow will:

  • Demonstrate knowledge and understanding of regulations and guidances and how they apply to regulatory registrations
  • Demonstrate knowledge of the drug development process to build robust registration plans, and to influence teams regarding registration applications
  • Own 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
  • Demonstrate and apply deep understanding of regulations and guidances for compliance submissions
  • Lead registration application planning and execution to ensure meeting regulations while meeting team needs
  • Influence and partner within GRA and cross-functionally to ensure operational consistency while meeting team needs

Regulatory Affairs: Advertising/Promotional Material

The Visiting Scientist Fellow will:

  • Understand the FDA regulations and guidance documents and how they apply to advertising and promotion
  • Attend US brand team meetings regularly and actively participate in making recommendations regarding proposed promotional activity plans
  • Stay apprised of the external environment related to promotion and advertising and potential ramifications on the pharmaceutical industry

Regulatory Affairs: Labeling

The Visiting Scientist Fellow will:

  • Develop and update Core (Core Data Sheet and Core Device Labeling) and US labeling (Prescribing Information, Patient Packaging Information, Medication Guides, Instructions for Use, Packaging Components) based on internal guidelines, internal procedures, and US FDA regulations and guidance
  • Apply labeling regulations, competitor knowledge, regulatory precedent to evaluate and set labeling parameters, understand and communicate the impact of decisions, influence drug development strategy and propose feasible language for marketed product labeling updates to influence commercially viable labeling
  • Collect affiliate labeling change requests and network them with product team for decisions
  • Collaborate with Regulatory team regarding labeling strategic plans/issues

Regulatory Affairs: Regulatory Policy and Intelligence

This is a split role between US Regulatory Policy and International Regulatory Policy and Intelligence. The Visiting Scientist Fellow will:

  • Identify and assess external regulatory trends that pose opportunities or threats for the pharmaceutical industry
  • Develop Lilly positions on key regulatory policy issues and advocate for policy change in the US, Europe, and other countries
  • Cultivate opportunities to engage in industry associations and other multi-stakeholder coalitions to achieve shared regulatory policy objectives
  • Evolve regulatory intelligence capabilities for several emerging market countries
  • Contribute to briefings and updates for Lilly senior leadership and other colleagues

Global Pricing, Reimbursement and Access: New Product Planning

The Visiting Scientist Fellow 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. The Visiting Scientist Fellow will:

  • Develop exceptional understanding of payer’s needs in key markets from a macro-environmental level and for specific diseases and medicines
  • Work with business partners to represent these payer requirements to inform the commercial strategy and clinical development program of medicines within the pipeline
  • Develop strategic price recommendations and other inputs for use in forecasting

Clinical Trial Material Manufacturing and Services Project Management

The Visiting Scientist Fellow will:

  • Learn the application and integration of key project management processes and tools across teams, projects and functional areas to deliver clinical trial material with quality, on time, on budget and within scope
  • Lead CTMMS initiatives to enhance the delivery the right drug to the right patient at the right time while ensuring alignment with the global clinical strategies
  • Partner with cross-functional CTMMS groups to provide project management support
  • Utilize excellent self–management, leadership, communication and organizational skills to effectively manage upward and cross-functional; communications, risks and mitigation strategies, documentation of key team/asset information, decisions, and ensures project teams and leadership are kept up to date

Clinical Development, Information and Optimization (CDIO)

The CDIO organization is service organization which drives collaboration and transparency, through the use of rich data sources, and novel technologies. The Visiting Scientist Fellow will:

  • Lead the clinical study team through the design, planning and implementation of new trials or those trials utilizing the digitalized software capability and technology
  • Facilitate the design of clinical programs and trials through “clinical design jam sessions” in order to support decision making
  • Research available data sources to collate critical data to support trial design and operation decisions

Clinical Open Innovation

The Clinical Open Innovation (OI) team at Lilly leads development of new models of work for patient-centric clinical development and knowledge generation. Our focus is primarily with external organizations for collaborative innovation to meet patient needs. The Visiting Scientist Fellow will:

  • Leverage expertise and experience in clinical sciences along with social engineering techniques to engage people in accelerating innovation through OI techniques
  • Lead the development of specific sub-projects for new models of work to generate and manage new clinical information
  • Work closely with the OI team to leverage web technologies combined with social engineering and networking approaches
  • Apply new models of work including community management approaches and crowdsourced analytics to answer key questions in clinical development ranging from standard of care to regulatory strategies to predictive models for clinical operations (e.g., patient cohort availability and trial enrollment predictions)

Project Management

The Visiting Scientist Fellow will:

  • Incorporate deliverables across Clinical, Chemistry/Manufacturing/Control, Toxicology, ADME, Regulatory, Health Outcomes, Legal, Discovery and Marketing into a single, global integrated plan
  • Drive the application of key project management processes and tools to translate the integrated plan into an operational plan including a timeline, budget, and risk management strategy
  • Facilitate and enable execution of the operational plan to deliver asset and portfolio value on time, on budget, and within scope
  • Effectively manage cross-functional communications, anticipate and resolves issues, and ensures project management systems are up to date
  • Demonstrate leadership through project management tools and processes, exercising good judgment, and learning agility in order to effectively drive the project team with the "end in mind."

Global Patient Safety: Clinical Research Scientist

The 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 Visiting Scientist Fellow will:

  • Understand the process and regulations for adverse events reporting and drug safety in clinical development as well as postmarketing
  • Lead and guide the safety surveillance activities of scientists on the team including signal detection and clarification activities and risk evaluation activities
  • Provide medical expertise in safety risk management activities
  • Manage decisions and actions to be taken in order to demonstrate a positive benefit-risk balance for Lilly products

Global Public Policy

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. The Visiting Scientist Fellow will:

  • Understand policy issues of focus including health technology assessment, regulatory reforms, and health benefits design.
  • Work cross-functionally with the policy team to apply scientific knowledge to legislative policy analysis in order to develop new policy solutions and advocate for policy changes.

Application and Selection Process

The Visiting Scientist Fellowship will be recruiting for the fellowship year from November through January. Applicants must have completed their PharmD, PhD, MD, or MPH by May 2015, but not earlier than May 2011, to be eligible for the Visiting Scientist Fellowship. Qualified candidates must be legally authorized to be employed in the United States. Eli Lilly and Company does not anticipate providing sponsorship for employment visa status (e.g., H-1B status) for this employment position.

Screening interviews for PharmD candidates are conducted at the ASHP Midyear Clinical Meeting. On-site interviews are conducted in January and February. The selection process is generally completed by the end of February.

If you have any questions, contact:

Jay Kissel, PhD
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285

email: kisselja@lilly.com

 

Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.​​