Clinical Research Physician - Development

Role Summary

Clinical Research Physician – Development leads late‑phase clinical trials within the cardiovascular pillar, serving as Lead Study Physician for a Phase 3 CV Outcome Trial. This role ensures global clinical trial planning, execution, and data dissemination in support of product registration, commercialization, and demand realization, while maintaining compliance with GCPs and applicable regulations.

Responsibilities

• Clinical Planning
  • Contribute to business unit and global alignment of clinical strategy and clinical plans.
  • Understand and stay updated with pre-clinical and clinical data relevant to the molecule.
  • Collaborate with pre-clinical, early phase, clinical pharmacology, global safety, regulatory groups for development of clinical development plans and clinical protocols.

• 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 project timelines.
  • Provide oversight and input into Informed Consent Documents (ICD).
  • Collaborate with clinical research staff in design, conduct, and reporting of local clinical trials (e.g., sample size, timelines, grants, governance reviews).
  • Review and approve risk profiles to ensure appropriate communication of risk to study subjects.
  • Participate in investigator identification and selection with clinical teams.
  • Ensure operational teams have documented completion of administrative requirements for study initiation and conduct in line with GCPs and local laws.
  • Assist in planning and participate in study start-up meetings to train investigators and site personnel.
  • Serve as a resource to clinical operations personnel, monitors, investigators, and ethics review boards to address questions.
  • Address scientific information needs of investigators and personnel.
  • Monitor patient safety and track adverse events per corporate patient safety policies.
  • Review IIT proposals/publications as requested; collaborate with statistics to generate aggregate internal reports.
  • Present to committees as appropriate (e.g., DMC, National Leader, Executive committee).

• Scientific Data Dissemination/Exchange
  • Ensure compliance with local laws and global policies on data dissemination and interactions with external healthcare professionals.
  • Address unsolicited scientific information needs of external healthcare professionals per guidelines.
  • Participate in reporting clinical trial data in registry activities.
  • Support planning of symposia, advisory boards, and meetings with healthcare professionals.
  • Support medical information with preparation/review of medical letters and information materials.
  • Prepare/review scientific information in response to customer questions or media requests.
  • Provide follow-up information to healthcare professionals per SOPs.
  • Support data analysis and development of slide decks and publications; establish collaborations with external experts and professional societies.
  • Support design of customer research as medical expert and train medical personnel.
  • Provide congress support (speaking engagements, exhibits, customer events).
  • Participate in data analysis, dissemination, and final reports/publications.

• Regulatory Support Activities (as appropriate for the molecule stage)
  • Provide medical content to regulatory documents and expert input to regulatory scientists.
  • Assist in regulatory reports and preparation for advisory committee hearings; local registration efforts and global regulatory issues.
  • Participate in advisory committees; contribute to risk management planning with affiliates and GPS.
  • Develop and review label changes in collaboration with affiliates, brand teams, regulatory, and legal.
  • Contribute to medical strategies to support brand commercialization; address development customer information needs; engage with marketing to support demand realization.
  • Support payer, patient, and provider questions with data analyses and research efforts; maintain relationships with external experts and thought leaders.
  • Contribute to strategic brand planning and assist in developing promotional materials as needed.

• Scientific / Technical Expertise and Continued Development
  • Critically read and evaluate medical literature; stay updated on product‑relevant developments.
  • Understand trends in clinical practice and access in relevant therapeutic areas.
  • Responsible for scientific training of the clinical study team; act as scientific consultant/protocol expert.
  • Pursue extramural scientific experiences and attend scientific symposia.

• General Responsibilities
  • Support management in budget preparation and administration; participate in professional development and recruitment efforts.
  • Collaborate with alliance, business, and vendor partners; provide timely feedback to colleagues.
  • Participate in committees, Six Sigma initiatives, and other task forces; maintain qualification and training standards; model leadership behaviors.
  • Be an ambassador of patients and the Lilly Brand.

Qualifications

• Required: Medical Doctor or Doctor of Osteopathy; board eligible or certified in appropriate specialty/subspecialty or equivalent post‑medical school training; US trained physicians must be board eligible or certified. Non‑US trained physicians must have LCME‑compliant medical education.
• Preferred: Clinical research or pharmaceutical medicine experience; strong knowledge of the drug development process; fluent in English (written and spoken); excellent communication, interpersonal, organizational, teamwork, and negotiation skills; demonstrated ability to influence cross‑functional teams; ability to travel domestically and internationally as needed.

Additional Requirements

• Travel: Ability to engage in domestic and international travel to support the business needs.