Clinical Research Physician

Clinical Research Physician (CRP)

Core Responsibilities
- Collaborate on development/maintenance of 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 clinical plans.
- Stay updated on pre-clinical and clinical data relevant to the molecule.
- Plan, collaborate on, and review scientific content of clinical documents (protocols, informed consent documents, final study reports, submissions) per project timeline.
- Collaborate on the design, conduct, and reporting of local clinical trials (e.g., sample size, patient commitment, timelines, grants, governance review interactions).
- Review/approve risk profiles to ensure appropriate risk communication to study subjects.
- Participate in investigator identification and selection.
- Ensure administrative requirements for study initiation/conduct are completed (ethical review board, informed consent, regulatory approval/notification) consistent with GCPs and local laws.
- Participate in study start-up meetings; provide training and information to investigators and site personnel.
- Serve as a resource to clinical operations, clinical research monitors, investigators, and ethical review boards.
- Monitor patient safety and track/follow up adverse events in alignment with corporate patient safety policies/procedures.
- Review IIT proposals and publications (as requested).
- Address unsolicited scientific information needs of external healthcare professionals in compliance with laws and policies.
- Support data analysis and development of publications and other medical information materials.
- Participate in Clinical Trial Registry reporting.
- Prepare/review scientific information for customer questions or media requests.
- Support planning/participation in symposia, advisory boards, congresses, and other HCP meetings.
- Establish/maintain collaborations with external experts, thought leaders, and professional societies.
- Support training of medical personnel.
- Participate in development/review of label changes and labeling modifications.
- Support preparation of regulatory reports (NDAs, FDA annual reports, PADERs), FDA advisory committee preparations, local registration, and resolution of regulatory issues.
- Participate in risk management planning with affiliates and Global Patient Safety (GPS).
- Develop medical strategies to support brand commercialization; support payer partnership programs and product value.
- Support business-to-business and business-to-government activities as medical expert.
- Contribute to development/review/approval of promotional materials and tactics.
- Define Patient Journey and Moments of Truth; act as patient advocate and medical expert.
- Critically read/evaluate medical literature; stay updated on competitive products and medical/scientific developments.
- Be aware of clinical practice and access trends/projections (1–2 and 3–5 years).
- Act as scientific consultant/protocol expert for study teams and medical colleagues.
- Support development budget administration; set/meet professional goals and contribute to others’ development.
- Participate in recruitment, diversity, and retention efforts.
- Collaborate with alliance, business, and vendor partners; provide coaching/feedback.
- Ensure qualification and training in required tasks (maintain training map).
- Model leadership behaviors and act as ambassador for patients and the Lilly Brand.

Essential Requirements
- Medical Doctor: board eligible/certified in appropriate specialty/subspecialty, or comparable post-medical school clinical training for the country of hiring. US-trained physicians must have achieved board eligibility/certification.
- Non-US trained physicians: education/training at a medical school meeting LCME requirements (see listed reference).
- Fluent in English (written and verbal).
- Demonstrated knowledge of drug development process.
- Experience of international oncology practice.

Additional Preferences
- In-depth knowledge of breast oncology.
- Experience with CDK 4 & 6 inhibitors.
- Strong communication, interpersonal, organizational, teamwork, and negotiation skills.
- Ability to influence others cross-functionally to create a positive working environment.
- Ability to engage in domestic and international travel as appropriate.
- Clinical research or pharmaceutical medicine experience preferred.
- EU countries where role can be based: Austria, Belgium, Spain, France, Germany, Greece, Ireland, Italy.