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 is a remote position reporting 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.
• 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.
• 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.

Essential Requirements

• Medical Doctor.
• 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.
• 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.

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 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.

Section on Benefits, Pay, and Schedule

(Note: Specific details about benefits, pay, and schedule are not provided in the job posting.)

Section on EEO/Equal Opportunity

(Note: Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance.)