Eli Lilly and Company

Senior Clinical Research Scientist, Diabetes Connected Care

Location
Cambridge, MA, United States
Posted
Nov 03, 2018
Ref
43472
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 Lilly Innovation Center in Cambridge, Massachusetts allows Lilly to explore how next generation therapeutics, emerging technologies, data analytics and new models can improve patient health while reducing the clinical, psychosocial and economic burden that is systemic throughout healthcare today. Our team in Cambridge shares a passion for challenging conventional wisdom and crafting an environment that embraces prioritizing high-risk, breakthrough concepts. The center provides a start-up environment with large company support. We are located in the core of Massachusetts exploding science and technology cluster, walking distance to some of the best academic and industry innovators in the world. The center has been designed to cultivate collaborative drug, device and technology research across all of Lilly's therapeutic areas.

Do you have experience growing and developing complicated products, with hands on expertise in a clinical setting? How would you like a career where you get to use your best analytical skills to make a substantial difference in the well-being of people across the globe?

Crafting an outcome through the application of scientific and clinical training, the Clinical Research Scientist (CRS) is an integral contributor to strategic planning. This role is in the support of growing the launch and commercialization activities to meet patients' needs. Ultimately, the role will enhance the customers' experience in interacting with the company.

The definition of "customer" includes patients, providers (HCPs) and payers. The CRS may also work closely with: Global Development teams, Therapeutic Area Program Phase, and Early Phase / Clinical Pharmacology. Additionally, you may partner with Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical trial phases.

In this role, you will serve as a scientific resource for study teams, departments, and others as needed. You will be aware of and ensure that all activities of the medical team (and direct reports, if applicable) are compliant. This compliance includes: current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, and the Principles of Medical Research. The CRS will also ensure activities are aligned with the medical vision.

Primary responsibility:
  • Provide experienced support to all aspects of development, to ultimately improve the customers' interaction
  • Improving the "patient journey" and the strategic plan for the asset
  • 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)
  • Medical support for Pricing, Reimbursement, and Access (PRA; providing medical guidance on the PRA plan and interacting with government PRA agencies as needed)
  • Lead in local scientific data dissemination (presenting at conferences, advisory boards, etc., and handling the development of the scientific content of educational programs)
  • 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). This role will collaborate with local medical staff as well as clinical sites in the startup and conduct of clinical studies, as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan
  • In addition, if assigned by the Business Unit Medical Leader, the CRS is responsible for providing support for global studies conducted in specific affiliates/countries

Specific activities include:
  • Contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility
  • Developing, conducting and giving reports of local/regional clinical trials
  • Implementing global clinical trials conducted in local affiliates/countries
  • 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
  • Contact regulatory and other governmental agencies
  • Outreach medical activities aimed at the external clinical customer community, including leaders with vision
  • And various medical activities supporting demand realization
43472BR

Basic Qualifications
  • 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/Nurse Educator) OR
  • Have a BS or Masters degree in health/medical/scientific or related field and 7+ years of professional work experience that is directly related to at least one of the following:
    • Experience in areas relevant to drug discovery
    • Drug development experience (for example, clinical development, regulatory affairs, medical affairs, human factors)
  • Professional work experience with device development


Additional Skills/Preferences
  • Experience in the development and clinical testing of Class III medical devices for diabetes (e.g. continuous glucose monitors, artificial pancreas systems, etc.)
  • Deep therapeutic area expertise in diabetes, including experience in the planning, design, and implementation of clinical trials
  • Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
  • Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills
  • Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
  • Experience in working with regulatory agencies, including but not limited to FDA, EMA, PMDA, and/or CFDA
  • Experience in hazard classification of medical devices, as well as FMEA techniques and/or human factors studies


Additional Information
  • 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