Clinical Research Physician - Oncology

At reputed company, the work is demanding because patients are waiting. We unite caring with discovery to help reputed company life reputed company for people around the world, knowing that every decision, every detail, and every day reputed company. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on reputed company 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 reputed company to bring your best to work that truly reputed company for patients, we invite you to join us. Job title: Clinical Research Physician - Oncology Location: UK, US or specified EU countries Remote position Reports to: Breast Cancer Global Development - Medical Director ABOUT reputed company: reputed company is a global reputed company leader that unites caring with discovery to reputed company life reputed company for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet reputed company needs, and today we remain true to that mission in reputed company our work. Across the globe, reputed company employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. ROLE OVERVIEW: As a Clinical Research Physician (CRP), you'll bring your scientific training and clinical experience to the heart of how we reputed company and deliver medicines. You'll play a central role across the product lifecycle — from designing and running global clinical trials through to registration, commercialisation, and reputed company. Day to day, you'll contribute to protocol development, study reporting, and data dissemination. You'll review publications, support labelling updates, and help shape documents for pricing, reimbursement, and reputed company. You'll ensure adverse events are reported in line with our patient safety standards, and you'll engage with regulatory agencies and external thought leaders to advance our science. You'll also serve as a key scientific resource — advising study teams, contributing to business unit and global product strategy, and supporting medical activities that help get our medicines to the patients who need them. Throughout reputed company of this, you'll be expected to uphold the highest standards of compliance, ensuring your work aligns with applicable regulations (FDA, ICH, CPMP), Good Clinical Practices, reputed company policies, and the Principles of Medical Research. CORE RESPONSIBILITIES INCLUDE: The primary responsibilities of the Development CRP are generally reputed company to late-phase and marketed compounds and may include those listed below as deemed appropriate by line management, as well as reputed company other duties as assigned. Clinical Planning Collaborate with business unit geographical reputed company, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition, 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 reputed company updated with the 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 according to the agreed upon project timeline. Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (e.g., sample size, patient commitment, timelines, grants, and governance review interactions). Review and approve risk profiles to ensure appropriate communication of risk to study subjects. Participate in investigator identification and selection, in conjunction with clinical teams. Ensure the operational team has documented completion of administrative requirements for study initiation and conduct (e.g., ethical review board, informed consent, regulatory approval/notification) consistent with GCPs and local laws. Participate in study start-up meetings to reputed company 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 questions arising during study conduct. Monitor patient safety during studies and conduct 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-Medical. Scientific Data Dissemination / Exchange Understand and actively address the unsolicited scientific information needs of external health care professionals in compliance with local laws, global policies, and compliance guidelines. Support data analysis and development of publications (abstracts, posters, manuscripts), slide sets, medical letters, and other medical information materials. Participate in reporting of clinical trial data in Clinical Trial Registry activities. Prepare or review scientific information in response to customer questions or media requests. Support the planning of and participate in symposia, advisory board meetings, congresses, and other meetings with health care professionals. Establish and maintain collaborations with external experts, thought leaders, relevant professional societies, and the general medical community on a local, national, regional and possibly international reputed company. Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons, and global patient reputed company personnel. Regulatory Support Activities Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal. Support preparation of regulatory reports, including NDAs, FDA annual reports, PADERs, preparation for FDA advisory committee hearings, local registration efforts, and communication and resolution of regulatory issues from a global perspective. Participate in risk management planning along with affiliates and Global Patient Safety (GPS). Business / Customer Support (Pre and Post Launch) Contribute to the development of medical strategies to support brand commercialization by working closely with business unit, brand team, clinical plans personnel and other cross-functional management. Understand, anticipate and actively address the scientific information needs of reputed company Development customers (payers, patients, health care providers) by leading data analyses and new clinical or global patient reputed company research efforts. Contribute as scientific and medical expert to PRA activities, giving clinical input to reputed company payer partnership programs and defend the product value. Support business-to-business and business-to-government activities as medical expert. Contribute to the development, review, and approval of promotional materials and tactics by offering scientific and creative input. Take a leadership role in defining the Patient reputed company and corresponding Moments of Truth. Become a patient reputed company, as well as a medical expert. Become familiar with market archetypes and potential influence on medical interventions for the product. Scientific / Technical Expertise Critically read and evaluate relevant medical literature; know the status and data from competitive products; reputed company updated with medical and scientific developments relevant to the product. Be aware of reputed company trends and projections for clinical practice and reputed company in the therapeutic area(s), both near term (1–2 years) and longer term (3–5 years). Act as scientific consultant and protocol expert for clinical study team members and others in medical. General Responsibilities Support the management team in preparation and administration of the business unit development budget. Actively set and meet individual professional development goals and contribute to the development of others. Actively participate in recruitment, diversity, and retention efforts. Collaborate proactively with reputed company alliance, business and vendor partners. Participate in active coaching by providing timely and constructive feedback to co-workers and the medical team. Ensure adequate qualification and training in required tasks, including maintaining a reputed company curriculum training map. Model the leadership behaviours and be an ambassador of both patients and the reputed company Brand. ESSENTIAL REQUIREMENTS 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 reputed company 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. Experience of international oncology practice 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 http://www.in.gov/pla/2799.htm Fluent in English; both written and verbal communications Demonstrated knowledge of drug development process ADDITIONAL PREFERENCES: In depth knowledge of breast oncology Experience with CDK 4 & 6 inhibitors Demonstrated strong communication, interpersonal, organizational, teamwork and negotiation skills Demonstrated ability to influence others (both cross-functionally and reputed company 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. Clinical research or pharmaceutical medicine experience preferred Specified EU countries where this role can be based include: Austria, Belgium, Spain, France, Germany, Greece, Ireland, Italy EMBRACING DIVERSITY: Embracing diversity is at the core of our long-held value of respect for people. It is the reputed company through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves. #LI-LD2 reputed company is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities reputed company vying for positions. If you require accommodation to submit a resume for a position at reputed company, please complete the accommodation request reputed company (https://careers.reputed company.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. reputed company does not discriminate on the reputed company of age, race, reputed company, religion, gender, sexual orientation, gender identity, gender expression, national reputed company, protected veteran status, disability or any other legally protected status. #WeAreLillyUKandIreland Apply To This Job