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 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.
Purpose:
Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Clinical Research Scientist - Clinical Development: Neuropsychologist is an integral member of the Neuroscience medical development team and participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; 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; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.
The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.
Overall Responsibilities :
With the expansion of the Lilly portfolio, this role will be responsible for scientific support for clinical trials across the Neuroscience platform and serves a spectrum of patients with neurological and psychiatric conditions. The clinical research scientist is a scientific resource for study teams, departments, and others as needed, particularly pertaining to the selection of clinical trial endpoints, the implementation and central monitoring strategy of clinical endpoints and the translation of clinical trial outcome data into meaningful benefits. This includes, but is not limited to, design and execution of phase 2/3 studies to address the needs of the commercial organization.
The ideal candidate will be a critical thinker and understand Neuroscience, Neuropsychology, neuropsychological assessment and measurement science.
Specific responsibilities may include but are not limited to:
Clinical Planning
Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
Contribute to business unit and global alignment of clinical strategy and clinical plans.
Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
Clinical Research/Trial/ Execution and Support
Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline.
Provide protocol oversight and input into informed consent documents.
Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
Review and collaborates with CRP on the approval of risk profiles to ensure appropriate communication of risk to study subjects.
Participate in investigator identification and selection, in conjunction with clinical teams.
Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
Serve as resource to clinical operations/CTMs/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
Understand and actively address the scientific information needs of all investigators and personnel.
Review lIT proposals and publications, as requested by CRP or Director-Medical.
Scientific Data Dissemination/Exchange
Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.
Understand and address the unsolicited scientific information needs of external health care professionals according to guidelines above.
Participate in reporting of clinical trial data in Clinical Trial Registry activities.
Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
Prepare or review scientific information in response to customer questions or media requests
Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.
Support the design of customer research as medical expert
Support medical information associates in preparation and review of medical letters and other medical information materials.
Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
Develop and maintain appropriate collaborations and relationships with relevant professional societies.
Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel.
Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events)
Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
Regulatory Support Activities
Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
Provide medical expertise to regulatory scientists.
Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
Participate in advisory committees.
Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
Scientific I Technical Expertise and continued development
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 clinical study team.
Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
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).
Explore and take advantage of opportunities for extramural scientific experiences
Attend, contribute and participate in scientific symposia, as well as administrative/business workshops and training.
General Responsibilities
Actively set and meet individual professional development goals and contribute to the development of others.
Support the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget.
Actively participate in recruitment, diversity and retention efforts.
Collaborate proactively and productively with all alliance, business and vendor partners.
Participate in active coaching by providing timely and constructive feedback to co-workers, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness.
Participate in committees, process improvement initiatives and task forces as requested by local/corporate management
Ensures that at all times is adequately qualified and trained in the tasks required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self.
Model the leadership behaviors
Be an ambassador of both patients and the Lilly Brand
Basic Requirements:
Doctoral level Degree (Ph.D, Psy.D or equivalent) in Clinical Neuropsychology with 2+ years industry or academic experience beyond any postdoctoral positions.
Demonstrated experience in clinical and/or research settings in working with adults with neurological and/or psychiatric disorders
Clinical experience in conducting assessments and administering standardized scales within a clinical and/or research @context.
Experience and agility in the conduct and interpretation of statistical and psychometric analyses
Evidence of scientific track record in publications, conference presentations
Additional Information:
Fluent in English, written and verbal communications
Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team.
Position Location - Indianapolis, IN or Remote
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$142,500 - $228,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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