• Accountable for the trial activities for responsible R/OPU • Ensure the trial is conducted in compliance with GCP-ICH, local/global regulations • Creation, management and review of the R/OPU trial budget • Timely budget updates based on trial changes • Appropriate trial-specific training of R/OPU internal and external partners • Verifies and provides input into the country and site level feasibility • Finalize and validate site selection • Development and implementation of country level engagement plans • Coordinating development of country level patient facing documents • Ensure timely responses to questions from Regulatory Authority/Ethics Committee • Maintains oversight during clinical trial conduct • Monitor progress of patient recruitment endpoints • Establish and maintain relationships with external experts, investigational sites, etc.

Title: Forensic Psychologist - Clinical Supervisor Location: CA - Irvine Job Description: - CA - Irvine - - Psychologist - Director | Manager | Supervisor - - Full Time - - 728568 Psychologists are encouraged to consider an available Clinical Supervisor position with Liberty Healthcare’s multi-site forensic mental health program in California. This program exclusively serves justice-involved adults who are experiencing mental illness and have recently been determined to be incompetent to stand trial. The goal of this program is to provide rapid mental health services to people in need - so they may achieve improved behavioral health outcomes as quickly as possible. Services are provided onsite to inmates at several county jails in located in San Bernardino, Riverside, San Diego, and San Mateo Counties. As Liberty Healthcare’s Clinical Supervisor, you will enjoy an array of responsibilities, including: - Overseeing forensic evaluations for people who are justice involved and experiencing mental illness - Ensuring clinical services are consistent with best practices in the forensic mental health field - Leading various quality assurance, compliance, and training initiatives - Direct and indirect supervision of licensed clinicians and ancillary professionals - Collaborating with the program’s Executive Director as well as program leaders and staff - Fostering collaborative relationships with stakeholders at the California Department of State Hospitals and county sheriff’s departments - Providing clinical services occasionally as needed This is primarily a remote role which will allow you to work remotely from your home office in California. Although infrequent, you may be required to occasionally travel to service locations (mostly in Southern California). As a full-time employee of Liberty Healthcare in this role, you can expect: - Starting pay between $130,000 and $145,000 (depending on qualifications) - Health insurance, dental insurance, vision insurance, life insurance, and disability insurance - 30 days of paid time off each year for holidays, vacation, sick leave, and personal days - Health Savings Account, 401k plan, and other perks You are a good fit for this role if you possess the following: - Professional licensure in California as a Clinical Psychologist - At least two years of forensic mental health experience - Knowledge of best practices in the evaluation and treatment of justice involved people who are experiencing mental illness - Ability to lead others Although this is a remote position, California residency is required. Liberty Healthcare is an equal opportunity employer committed to diversity, equity, and inclusion. Our organization is composed of, and proudly serves, people of diverse backgrounds and abilities.

Title: Forensic Psychologist - Clinical Supervisor Location: Rancho Cucamonga United States Job Description: Psychologists are encouraged to consider an available Clinical Supervisor position with Liberty Healthcare’s multi-site forensic mental health program in California. This program exclusively serves justice-involved adults who are experiencing mental illness and have recently been determined to be incompetent to stand trial. The goal of this program is to provide rapid mental health services to people in need - so they may achieve improved behavioral health outcomes as quickly as possible. Services are provided onsite to inmates at several county jails in located in San Bernardino, Riverside, San Diego, and San Mateo Counties. As Liberty Healthcare’s Clinical Supervisor, you will enjoy an array of responsibilities, including: - Overseeing forensic evaluations for people who are justice involved and experiencing mental illness - Ensuring clinical services are consistent with best practices in the forensic mental health field - Leading various quality assurance, compliance, and training initiatives - Direct and indirect supervision of licensed clinicians and ancillary professionals - Collaborating with the program’s Executive Director as well as program leaders and staff - Fostering collaborative relationships with stakeholders at the California Department of State Hospitals and county sheriff’s departments - Providing clinical services occasionally as needed This is primarily a remote role which will allow you to work remotely from your home office in California. Although infrequent, you may be required to occasionally travel to service locations (mostly in Southern California). As a full-time employee of Liberty Healthcare in this role, you can expect: - Starting pay between $130,000 and $145,000 (depending on qualifications) - Health insurance, dental insurance, vision insurance, life insurance, and disability insurance - 30 days of paid time off each year for holidays, vacation, sick leave, and personal days - Health Savings Account, 401k plan, and other perks

Clinical Research Physician - Ophthalmology locations US: USA Remote time type Full time Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Ophthalmologic Gene Therapy Development Clinical Research Physician (CRP) for LRM participates in the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of ophthalmologic products and other products, as required. This includes participating in: 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); 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 all relevant products, including various medical activities in support of demand realization. The CRP serves as a scientific and medical resource with specific expertise in ophthalmology for study teams, departments, and others as needed. Primary Responsibilities Clinical Planning - Understand and keep updated with the pre-clinical and clinical data relevant to the product(s). - Contribute to business unit and global alignment of clinical strategy and clinical plans. - Collaborate with the appropriate LRM leaders 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. Clinical Research/Trial Execution and Support - Plan, collaborate on, and review the scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports) according to the agreed upon project timeline. - Provide oversight and input into integrated clinical development plans (ICDs) - Collaborate with clinical research staff in the design, conduct and reporting of clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions). - Review and approves risk profiles to ensure appropriate communication of risk to study subjects. - Participate in investigator identification and selection for the purposes of clinical trials, in conjunction with clinical teams, and in center of excellence identification to the extent relevant to the commercial model. - 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 personnel/clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. - Understand and actively addresses the scientific information needs of all investigators and personnel. - Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures. - Review IIT proposals and publications, as requested by Director-Clinical/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 actively 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. - 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). - 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. - Steward appropriate collaborations and relationships between Lilly and relevant professional societies. - Support the design of stakeholder (e.g., patient, HCP, payer) research as medical expert - 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). Business/ customer support (pre and post launch support) - Contribute to the development and, where appropriate, execution of medical strategies to support brand commercialization activities by working closely with LRM leadership, brand teams, clinical plans personnel and other cross-functional management during the development of the global and local business plan(s). - Understand and anticipate the scientific information needs of all Development customers (payers, patients, health care providers, policymakers). - Actively address Development customer (payer, patient, health care providers, and policymaker) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts. - Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts. - Contribute as a scientific and medical expert to activities and deliverables of the commercial organization, including giving clinical input and insight to develop PRA strategies and partnerships to demonstrate a product’s value. - Contribute actively on an ongoing basis to the strategic planning for the brand. - By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics as needed. - Become familiar with market archetypes and potential influence on the medical interventions for the product. - Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Become a patient advocate, as well as a medical expert. Scientific / 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. - Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product(s), both near term (1-2 years) and longer term (3-5 years). - 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. - Explore and take advantage of opportunities for extramural scientific experiences. - Attend scientific symposia. Minimum Qualifications - Medical Doctor. Must be board-eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification. Physicians trained outside the US who are not US board-eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer. - Non-US trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see PLA: Medical Licensing Information and Medical Education | MBC - Board-eligibility or certification in ophthalmology Additional Preferences: - At least 5 years clinical research or pharmaceutical medicine experience desirable, particularly in the setting of a biotechnology company - Demonstrated knowledge of drug development process - Fluent in English; both written and verbal communications - Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills - Demonstrated ability to influence others (both cross-functionally and within the function) 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 Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $198,000 - $389,400 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. #WeAreLilly