Clinical Research Physician - Clinical Development

secondary qualifications (preferred) Board certification in a relevant specialty (e.g., gastroenterology, internal medicine, pediatrics)Experience in clinical research, clinical practice, or pharmaceutical industry experience in the relevant therapeutic area (e.g., gastroenterology, immunology)Experience in clinical trial design, conduct, and/or reportingExperience in medical affairs, medical information, or medical communicationsExperience in working with regulatory agencies (e.g., FDA, EMA)Experience in working with external experts, thought leaders, and the general medical communityExperience in working with cross-functional teams (e.g., clinical, regulatory, commercial)Experience in working with global teams and/or in a global environmentExperience in working with alliance, business, and vendor partnersExperience in coaching, mentoring, and developing othersExperience in project management and/or Six Sigma initiatives Skills and Competencies Strong scientific and medical expertise in the relevant therapeutic area (e.g., gastroenterology, immunology)Strong clinical research skills, including protocol design, study conduct, and data analysisStrong communication skills, both written and verbal, with the ability to present complex scientific information to a variety of audiencesStrong interpersonal skills, with the ability to build and maintain effective relationships with internal and external stakeholdersStrong leadership skills, with the ability to influence and drive decision-makingStrong problem-solving skills, with the ability to think critically and creativelyStrong organizational skills, with the ability to manage multiple priorities and meet deadlinesStrong business acumen, with the ability to understand and anticipate customer needsStrong commitment to compliance and ethical standardsStrong commitment to patient safety and advocacyStrong commitment to diversity and inclusionStrong commitment to personal and professional development Travel Travel may be required, up to 25% of the time.

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. The CRP applies scientific and medical training, clinical expertise, and relevant experience to:

• Develop, conduct, and report corporate/global clinical trials in support of product registration and commercialization.
• Implement global clinical trials and ensure compliance with corporate patient safety policies.
• Review protocols, study reports, publications, and data dissemination for products, labels, and tools supporting pricing, reimbursement, and access (PRA).
• Engage with regulatory and governmental agencies, and participate in outreach medical activities with the external clinical community, including thought leaders.
• Contribute to the development and implementation of business unit and global strategy for the product.
• Serve as a scientific resource for study teams, departments, and others as needed.

The role ensures 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.

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.
  • Support business unit and global alignment of clinical strategy and clinical plans.
  • Stay updated with 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) according to project timelines.
  • Provide protocol oversight and input into informed consent documents.
  • Collaborate with clinical research staff in the design, conduct, and reporting of local clinical trials (e.g., sample size, patient commitment, timelines, grants, 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 operational teams document administrative requirements for study initiation and conduct (e.g., ethical review board approval, informed consent, regulatory approval) consistent with GCPs and local laws.
  • Assist in planning and participate in study start-up meetings and training for investigators and site personnel.
  • Serve as a resource to clinical operations, investigators, and ethical review boards to address questions or issues arising during study conduct.
  • Monitor patient safety during studies and conduct tracking and follow-up of adverse events, in alignment with corporate patient safety policies.
  • Review investigator-initiated trial (IIT) proposals and publications, as requested.
• Scientific Data Dissemination/Exchange:
  • Comply with local laws, regulations, and global policies regarding data dissemination and interactions with external healthcare professionals.
  • Address unsolicited scientific information needs of external healthcare professionals.
  • Participate in reporting clinical trial data in Clinical Trial Registry activities.
  • Support planning of symposia, advisory board meetings, and other meetings with healthcare professionals.
  • Support medical information associates in preparation and review of medical letters and other materials.
  • Prepare or review scientific information in response to customer questions or media requests.
  • Provide telephone follow-up or written information requested by healthcare professionals per global SOPs.
  • Support data analysis and development of slide sets (reviewing/approving) and publications (abstracts, posters, manuscripts).
  • Establish and maintain collaborations with external experts, thought leaders, and the medical community on local, national, regional, and international levels.
  • Develop and maintain relationships with relevant professional societies.
  • Support the design of customer research as a medical expert.
  • Train medical personnel, including geographic/affiliate medical personnel, medical and outcome liaisons, and global patient outcomes personnel.
  • Provide congress support (e.g., answer questions at exhibits, present posters, staff medical booths, meet thought leaders, participate in customer events).
  • Participate in data analysis, scientific data dissemination, and preparation of final reports and publications.
• Regulatory Support Activities:
  • Participate in the development and review of label changes and labeling modifications in collaboration 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), FDA advisory committee hearings, and label discussions.
  • Participate in advisory committees and risk management planning with affiliates and Global Patient Safety (GPS).
• Business/Customer Support (Pre- and Post-Launch):
  • Contribute to the development of medical strategies supporting brand commercialization by working closely with business units, brand teams, and cross-functional management.
  • Understand and anticipate the scientific information needs of Development customers (payers, patients, healthcare providers).
  • Address customer questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research.
  • Establish effective collaborations with marketing personnel to further corporate demand realization.
  • Maintain contact with external experts and opinion leaders, and provide credible scientific expertise.
  • Contribute as a scientific and medical expert to PRA organization activities, including developing payer partnership programs and defending product value.
  • Support business-to-business and business-to-government activities as a medical expert.
  • Contribute to strategic planning for the brand and provide scientific input for promotional materials and tactics.
  • Define the Patient Journey and Moments of Truth based on medical knowledge, and act as a patient advocate and medical expert.
  • Participate in PhRMA or other trade associations as appropriate.
• Scientific/Technical Expertise and Continued Development:
  • Critically evaluate relevant medical literature, competitive product data, and medical/scientific developments relevant to the product.
  • Stay updated with current trends and projections for clinical practice and access in the therapeutic area(s).
  • Train the clinical study team scientifically and act as a scientific consultant and protocol expert.
  • Explore opportunities for extramural scientific experiences and attend scientific symposia.
• General Responsibilities:
  • Support the management team in preparation and administration of the business unit development budget.
  • Set and meet individual professional development goals and contribute to the development of others.
  • Participate in recruitment, diversity, and retention efforts.
  • Collaborate proactively with alliance, business, and vendor partners.
  • Provide timely and constructive feedback to co-workers and others on the medical team.
  • Participate in committees, Six Sigma initiatives, and task forces as requested.
  • Maintain adequate qualifications and training for required tasks, including a current curriculum training map.
  • Model leadership behaviors and act as an ambassador for patients and the Lilly brand.

Requirements

• Medical Doctor (MD) or Doctor of Osteopathic Medicine (DO) degree.
• Preferred qualifications:
  • Board certification in a relevant specialty (e.g., gastroenterology, internal medicine, pediatrics).
  • Experience in clinical research, clinical practice, or the pharmaceutical industry in the relevant therapeutic area (e.g., gastroenterology, immunology).
  • Experience in clinical trial design, conduct, and/or reporting.
  • Experience in medical affairs, medical information, or medical communications.
  • Experience working with regulatory agencies (e.g., FDA, EMA).
  • Experience working with external experts, thought leaders, and the general medical community.
  • Experience working with cross-functional and global teams.
  • Experience working with alliance, business, and vendor partners.
  • Experience in coaching, mentoring, and developing others.
  • Experience in project management and/or Six Sigma initiatives.

Skills and Competencies

• Strong scientific and medical expertise in the relevant therapeutic area (e.g., gastroenterology, immunology).
• Strong clinical research skills, including protocol design, study conduct, and data analysis.
• Strong written and verbal communication skills, with the ability to present complex scientific information to diverse audiences.
• Strong interpersonal skills, with the ability to build and maintain effective relationships with internal and external stakeholders.
• Strong leadership skills, with the ability to influence and drive decision-making