Clinical Research Physician - Clinical Development

must have a valid medical license to practice medicine in the United States or Puerto Rico. Must have a minimum of 2 years of clinical experience in the relevant therapeutic area (Immunology/Gastroenterology) or related field. Must have a minimum of 1 year of experience in clinical research, clinical drug development, or related field. Preferred Qualifications Additional experience in clinical research, clinical drug development, or related field beyond the minimum requirement. Experience in the pharmaceutical industry or related field. Experience in the development and implementation of clinical strategies and clinical plans. Experience in the design, conduct, and reporting of clinical trials. Experience in the review and approval of clinical documents, such as protocols, informed consent documents, and final study reports. Experience in the review and approval of risk profiles and communication of risk to study subjects. Experience in the identification and selection of investigators. Experience in the planning and conduct of study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Experience in the monitoring of patient safety during the conduct of studies and the appropriate tracking and follow-up of adverse events. Experience in the review and approval of lIT proposals and publications. Experience in the preparation and review of medical letters and other medical information materials. Experience in the preparation or review of scientific information in response to customer questions or media requests. Experience in the support of data analysis and the development of slide sets and publications. Experience in the establishment and maintenance of appropriate collaborations and relationships with external experts, thought leaders, and the general medical community. Experience in the development and maintenance of appropriate collaborations and relationships with relevant professional societies. Experience in the support of the design of customer research as medical expert. Experience in the training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel. Experience in the provision of congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events). Experience in the participation in data analysis, development of scientific data dissemination, and preparation of final reports and publications. Experience in the participation in the development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal. Experience in the provision of medical expertise to regulatory scientists. Experience in the support/assistance in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective. Experience in the participation in advisory committees. Experience in the participation in risk management planning along with affiliates and Global Patient Safety (GPS). Experience in the contribution to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans manager/project management associates and other cross-functional management during the development of the local business plan. Experience in the understanding and anticipation of the scientific information needs of all Development customers (payers, patients, health care providers). Experience in the active addressing of Development customer (payer, patient, and health care providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts. Experience in the establishment of effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization. Experience in the establishment and maintenance of contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts. Experience in the contribution as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value. Experience in the support of business-to-business and business-to-government activities as medical expert. Experience in the active contribution on an ongoing basis to the strategic planning for the brand. Experience in the offering of scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics as needed. Experience in the familiarity with market archetypes and potential influence on the medical interventions for the product. Experience in the taking of a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge. Experience in becoming a patient advocate, as well as a medical expert. Experience in the participation in PhRMA or other local or national trade associations as appropriate. Additional Skills Excellent written and verbal communication skills. Excellent interpersonal skills. Excellent organizational skills. Excellent problem-solving skills. Excellent critical thinking skills. Ability to work independently and as part of a team. Ability to work in a fast-paced environment. Ability to manage multiple priorities. Ability to travel as needed. Ability to work in a highly regulated environment. Ability to maintain confidentiality. Ability to work in a global environment. Ability to work in a matrix environment. Ability to work in a cross-functional environment. Ability to work in a collaborative environment. Ability to work in a team-oriented environment. Ability to work in a customer-focused environment. Ability to work in a patient-focused environment. Ability to work in a compliance-focused environment. Ability to work in a quality-focused environment. Ability to work in a safety-focused environment. Ability to work in a performance-focused environment. Ability to work in a results-focused environment. Ability to work in a deadline-focused environment. Ability to work in a detail-oriented environment. Ability to work in a process-oriented environment. Ability to work in a continuous improvement environment. Ability to work in a change-oriented environment. Ability to work in a learning-oriented environment. Ability to work in a development-oriented environment. Ability to work in a growth-oriented environment. Ability to work in a purpose-driven environment. Ability to work in a mission-driven environment. Ability to work in a values-driven environment. Ability to work in a culture-driven environment. Ability to work in a brand-driven environment. Ability to work in a patient-driven environment. Additional Information Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our company is committed to being a global leader in diversity and inclusion. We are dedicated to creating an environment where everyone feels welcome and has a sense of belonging. We are an equal opportunity employer and welcome all qualified candidates to apply for our open positions. We offer competitive compensation and benefits packages, as well as opportunities for professional growth and development. If you are looking for a challenging and rewarding career, we invite you to join our team at Lilly. To learn more about our company and our culture, please visit our website at www.lilly.com. Development Clinical Research Physician (CRP) – Immunology/Gastroenterology

About the role

This Development Clinical Research Physician (CRP) role within the Immunology/Gastroenterology therapeutic area supports early and late-phase clinical trials for assets in the gastroenterology pipeline. Through scientific and medical training, clinical expertise, and relevant experience, the CRP participates in the development, conduct, and reporting of corporate/global clinical trials to support registration and commercialization of the product.

The CRP serves as a scientific resource for study teams, ensuring all medical activities comply with current local and international regulations, laws, guidance (e.g., FDA, ICH, CPMP), Good Clinical Practices (GCPs), company standards, Lilly policies, and the Principles of Medical Research. The role aligns medical activities with the medical vision and supports global clinical strategy.

Responsibilities

• Clinical Planning:
  • Collaborate with business units, Discovery, Program Phase Medicine, and Clinical Pharmacology to develop and maintain a Draft Launch Label and Value Proposition addressing key customer needs (patient, provider, payer).
  • Contribute to the product lifecycle plan, clinical strategies, development plans, and study protocol design.
  • Ensure alignment of clinical strategy and plans across business units and globally.
  • Stay updated on pre-clinical and clinical data relevant to the molecule.
• Clinical Research/Trial Execution and Support:
  • Collaborate on and review scientific content of clinical documents (e.g., protocols, informed consent documents, final study reports, submissions like annual reports) according to project timelines.
  • Provide protocol oversight and input into informed consent documents.
  • Collaborate with clinical research staff on trial design, conduct, and reporting (e.g., sample size, patient commitment, timelines, grants, governance review).
  • 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 document administrative requirements for study initiation and conduct (e.g., ethical review board approvals, informed consent, regulatory approval) consistent with GCPs and local laws.
  • Assist in study start-up meetings and training for investigators and site personnel.
  • Serve as a resource for clinical operations, monitors, investigators, and ethical review boards to address issues during study conduct.
  • Monitor patient safety during studies and track/follow up on adverse events per corporate policies.
  • Review investigator-initiated trial (IIT) proposals and publications as requested.
• Scientific Data Dissemination/Exchange:
  • Comply with local laws, regulations, and global policies on data dissemination and interactions with external healthcare professionals.
  • Address unsolicited scientific information needs of external healthcare professionals.
  • Participate in Clinical Trial Registry activities and reporting.
  • Support planning of symposia, advisory boards, and meetings with healthcare professionals.
  • Support medical information associates in preparing and reviewing medical letters and materials.
  • Prepare or review scientific responses to customer questions or media requests.
  • Provide follow-up information to healthcare professionals per global SOPs.
  • Support data analysis, slide set development, and publications (abstracts, posters, manuscripts).
  • Establish and maintain collaborations with external experts, thought leaders, and the medical community.
  • Develop relationships with relevant professional societies.
  • Support design of customer research as a medical expert.
  • Train medical personnel (e.g., geographic/affiliate teams, medical liaisons, global patient outcomes personnel).
  • Provide congress support (e.g., answering questions at exhibits, oral/poster presentations, staffing medical booths, meeting thought leaders).
  • Participate in data analysis, scientific dissemination, and preparation of final reports/publications.
• Regulatory Support:
  • Participate in development and review of label changes and modifications with affiliates, brand teams, regulatory, and legal.
  • Provide medical expertise to regulatory scientists.
  • Support preparation of regulatory reports (e.g., NDAs, FDA annual reports, Periodic Adverse Drug Experience Reports), advisory committee hearings, and label discussions.
  • Participate in risk management planning with affiliates and Global Patient Safety (GPS).
• Business/Customer Support (Pre- and Post-Launch):
  • Contribute to medical strategies supporting brand commercialization by collaborating with business units, brand teams, and cross-functional management.
  • Understand and anticipate scientific information needs of Development customers (payers, patients, healthcare providers).
  • Address customer questions by leading data analyses and new clinical/global patient outcomes research.
  • Establish collaborations with marketing personnel to support demand realization.
  • Maintain contact with external experts and opinion leaders to facilitate scientific credibility.