Clinical Research Physician - Malignant Hematology

About the role

The Clinical Research Physician (CRP) participates in the development, conduct, and reporting of corporate/global clinical trials in support of registration and commercialization of products. This includes implementation of global clinical trials, reporting adverse events as mandated by corporate patient safety, review of protocols, study reports, publications, and data dissemination. The CRP serves as a scientific resource for study teams, departments, and others as needed, ensuring all medical team activities comply with current local and international regulations, laws, Good Clinical Practices, company standards, and the Principles of Medical Research.

Core Job Responsibilities

• Clinical Planning: Collaborate with business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in developing and maintaining Draft Launch Label and Value Proposition, product lifecycle plan, clinical strategies, development plans, and study protocol design; contribute to business unit and global alignment of clinical strategy and plans; understand and keep updated with pre-clinical and clinical data relevant to the molecule.
• Clinical Research/Trial Execution and Support: Plan, collaborate on, and review scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions; provide oversight and input into ICDs; collaborate with clinical research staff in design, conduct, and reporting of local clinical trials; review and approve risk profiles; participate in investigator identification and selection; ensure operational team has documented administrative requirements for study initiation and conduct consistent with GCPs; assist in planning and participate in study start-up meetings; serve as resource to clinical operations personnel, investigators, and ethical review boards; monitor patient safety and conduct appropriate tracking and follow-up of adverse events; review IIT proposals and publications.
• Scientific Data Dissemination/Exchange: Maintain knowledge of and compliance with local laws and global policies regarding data dissemination and interactions with external health care professionals; understand and address unsolicited scientific information needs of external health care professionals; participate in reporting clinical trial data in Clinical Trial Registry activities; support 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 materials; prepare or review scientific information in response to customer questions or media requests; provide follow-up or written information requested by health care professionals; support data analysis and development of slide sets and publications; establish and maintain collaborations with external experts, thought leaders, and medical community; support design of customer research; support training of medical personnel; provide congress support including availability at exhibits, oral and poster presentations, staffing medical booth, meeting thought leaders, and participating in customer events; participate in data analysis and preparation of final reports and publications.
• Regulatory Support Activities: Participate in development and review of label changes and labeling modifications; provide medical expertise to regulatory scientists; support preparation of regulatory reports including NDAs, FDA annual reports, PADERS, advisory committee hearings, and label discussions; participate in advisory committees; participate in risk management planning with affiliates and Global Patient Safety.
• Business/Customer Support: Contribute to development of medical strategies to support brand commercialization; understand and anticipate scientific information needs of payers, patients, and health care providers; lead data analyses and new clinical or global patient outcomes research efforts; establish collaborations with marketing personnel; maintain contact with external experts and opinion leaders; contribute as scientific and medical expert to PRA organization activities; support business-to-business and business-to-government activities; contribute to strategic planning for the brand; contribute to development, review, and approval of promotional materials; become familiar with market archetypes; take leadership role in defining Patient Journey and Moments of Truth; participate in PhRMA or other trade associations.
• Scientific/Technical Expertise and Continued Development: Critically read and evaluate relevant medical literature; know competitive product data; keep updated with medical and other scientific developments; be aware of current trends and projections for clinical practice and access in relevant therapeutic areas; responsible for scientific training of clinical study team; act as scientific consultant and protocol expert; explore opportunities for extramural scientific experiences; attend scientific symposia.
• General Responsibilities: Support management in preparation and administration of business unit development budget; set and meet individual professional development goals and contribute to development of others; participate in recruitment, diversity, and retention efforts; collaborate proactively with alliance, business, and vendor partners; participate in active coaching by providing timely and constructive feedback; participate in committees, Six Sigma initiatives, and task forces; ensure adequate qualifications and training for required tasks; model leadership behaviors; serve as ambassador of both patients and the Lilly Brand.

Basic Requirements

• Medical Doctor. Must be board eligible or certified in appropriate specialty/subspecialty or have completed 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).

Additional Preferences

• Minimum of 3 years industry experience in oncology or malignant hematology preferred.
• Demonstrated experience and knowledge of clinical research and the drug development process.
• Demonstrated strong communication, interpersonal, organizational, teamwork, and negotiation skills.

Other Information

Primary internal int