Clinical Research Physician -- Development

Eli Lilly and Company • Us, IN

1d • Hybrid

About The Position

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Development Clinical Research Physician (CRP) participates in: the development, conduct, medical monitoring, 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 CRP serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Physician must be familiar with, and ensure that all activities and vision of the medical team are aligned and in compliance with, current local and international regulations, laws, guidances (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. The primary responsibilities of the Development CRP are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.

Requirements

• Medical Doctor or Doctor of Osteopathy.
• 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).
• 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) 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.

Nice To Haves

• Clinical research experience in Psychiatry or Internal Medicine is strongly preferred.
• Minimum of 3 years of clinical development experience in an industry setting (or equivalent), including experience with medical monitoring and/or regulatory submissions, or 5 years of clinical research experience in academic setting

Responsibilities

• Clinical Planning: Primary responsibility of ongoing clinical trial monitoring. Oversees 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. Collaborates 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. Contributes to business unit and global alignment of clinical strategy and clinical plans. Understands and keeps 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 (for example, annual reports) according to the agreed upon project timeline. Provides oversight and input into ICDs. Collaborates 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). Reviews and approves risk profiles to ensure to ensure appropriate communication of risk to study subjects. Participates in investigator identification and selection, in conjunction with clinical teams. Ensures 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. Assists 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. Serves 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. Understands and actively addresses the scientific information needs of all investigators and personnel events, in alignment with corporate patient safety policies and procedures. Reviews IIT proposals and publications, as requested by 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. Understands and actively addresses the unsolicited scientific information needs of external health care professionals according to guidelines above. Participates in reporting of clinical trial data in Clinical Trial Registry activities. Supports the planning of symposia, advisory board meetings, and other meetings with health care professionals. Supports medical information associates in preparation and review of medical letters and other medical information materials. Prepares or reviews scientific information in response to customer questions or media requests. Provides telephone follow-up or specific written information requested by health care professionals as per global SOPs. Supports data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts). Establishes and maintains appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis. Develops and maintains appropriate collaborations and relationships with relevant professional societies. Supports the design of customer research as medical expert. Supports training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and global patient outcomes personnel. Provides 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). Participates in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
• Regulatory Support Activities: Participates in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal. Provides medical expertise to regulatory scientists. Supports/ assists 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. Participates in advisory committees. Participates in risk management planning along with affiliates and Global Patient Safety (GPS).
• Business/ customer support (core and post-launch support): Contributes to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans personnel and other cross-functional management during the development of the local business plan. Understands and anticipates the scientific information needs of all Development customers (payers, patients, health care providers). Actively addresses Development customer (payer, patient, and health care providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts. Establishes effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization. Establishes and maintains contact with external experts and opinion leaders; maintains a credible scientific expertise to facilitate these contacts. Contributes as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value. Supports business-to-business and business-to-government activities as medical expert. Contributes actively on an ongoing basis to the strategic planning for the brand. By offering scientific and creative input, contributes to the development, review, and approval of promotional materials and tactics as needed. Becomes familiar with market archetypes and potential influence on the medical interventions for the product. Takes a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Becomes a patient advocate, as well as a medical expert. Participate in PhRMA or other local or national trade associations.
• Scientific / Technical Expertise and continued development: Critically reads and evaluates the relevant medical literature; knows the status and data from competitive products; and keeps updated with medical and other scientific developments relevant to the product. Remains 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). 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. Explores and takes advantage of opportunities for extramural scientific experiences. Attends scientific symposia.
• General Responsibilities: Supports the management team, including the Sr. Director-Medical, in preparation and administration of the business unit development budget. Actively sets and meets individual professional development goals and contribute to the development of others. Actively participates in recruitment, diversity, and retention efforts. Collaborates proactively and productively with all alliance, business and vendor partners. Participates in active coaching by providing timely and constructive feedback to co-worker, others on the medical team, in the spirit of development, increased team effectiveness and cohesiveness. Participates in committees, Six Sigma 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. Models the leadership behaviors. Serves as an ambassador for both patients and the Lilly Brand.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree