Clinical Research Physician - Oncology

About the role

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We are seeking a Clinical Research Physician (CRP) to join our team in the UK, US, or specified EU countries. This role is remote and reports to the Breast Cancer Global Development - Medical Director.

Responsibilities

• Collaborate with business unit geographical regions, 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 keep updated with the pre-clinical and clinical data relevant to the molecule.
• 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 provide 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.
• Support data analysis and development of publications (abstracts, posters, manuscripts), slide sets, medical letters, and other medical information materials.
• 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 basis.
• Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons, and global patient outcomes personnel.
• 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).
• 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 all Development customers (payers, patients, health care providers) by leading data analyses and new clinical or global patient outcomes research efforts.
• Contribute as scientific and medical expert to PRA activities, giving clinical input to develop payer partnership programs and defend the product value.
• 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 Journey and corresponding Moments of Truth. Become a patient advocate, as well as a medical expert. Become familiar with market archetypes and potential influence on medical interventions for the product.
• 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 all 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 current curriculum training map.
• Model the leadership behaviours and be an ambassador of both patients and the Lilly Brand.

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.
• 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).
• Fluent in English; both written and verbal communications.
• Demonstrated knowledge of drug development process.

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 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.
• Clinical research or pharmaceutical medicine experience preferred.