Lilly Research Scientist-Clinical in Indianapolis, Indiana
Through the application of training and expertise, the Clinical Research Scientist (CRS) is an integral member of the medical affairs team for strategic planning in the support of launch and commercialization activities. This is done with a focus to meet patients’ needs and ultimately improve customers’ experience.
The CRS may also work closely with teams in new product development activities over the entire spectrum of drug development and clinical trial phases.
Specific activities include:
Building or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility.
Development, conduct and reporting of local clinical trials;
The implementation of 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;
Contributing to new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts;
Managing contacts with regulatory and other governmental agencies;
outreach medical activities aimed at the external clinical customer community, including thought leaders;
The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The CRS is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance, Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and activities are aligned with the medical vision.
Core Job Responsibilities
The primary responsibility of the CRS 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. This includes local marketed product support, medical support for regulatory affairs and interactions with government agencies, medical support for PRA, and leading in local scientific data dissemination. The CRS is responsible for collaborating with the global teams in the planning, startup and conduct of phase 3b/4 studies (and phase I and II studies where applicable), as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan.
Scientific Data Dissemination/Exchange
Clinical Research/Trial Execution and Support
Regulatory Support Activities
Scientific / Technical Expertise and continued development
Experience in musculoskeletal or cancer pain mechanisms is desirable
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.
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
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/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)
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.
Clinical Research Scientist - Pain
- An advanced health/medical/scientific or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following
3 years of clinical experience or
3-5 years of pharmaceutical experience (2 of which is in clinical development)
- Experience with the design and implementation of clinical trials is preferred.
- Have a BS or Masters degree in health/medical/scientific or related field and 7 years of pharmaceutical experience that is directly related to at least one of the following
Clinical trial experience
Experience in areas relevant to drug discovery
Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
If experience is either in 2 and or 3 only (for example, no clinical trial experience), the following must be provided as supporting evidence of candidates ability/capability to perform in a CRS role
Clear evidence and documentation of candidate’s direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical c medical, scientific or clinical information)
Candidate’s selection for CRS role must be endorsed by the BU Med affairs/development VP or equivalent area Senior leadership
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.
Do you have experience in medical affairs or drug development? Do you have experience in musculoskeletal or cancer pain mechanisms? Are you passionate about contributing to the exciting research happening in pain management? You are encouraged to review and consider this excellent opportunity as a Clinical Research Scientist.
State / Province: