Clinical Research Physician

Lilly

4d•Remote

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. As a Clinical Research Physician (CRP), you'll bring your scientific training and clinical experience to the heart of how we develop and deliver medicines. You'll play a central role across the product lifecycle — from designing and running global clinical trials through to registration, commercialisation, and beyond. Day to day, you'll contribute to protocol development, study reporting, and data dissemination. You'll review publications, support labelling updates, and help shape documents for pricing, reimbursement, and access. You'll ensure adverse events are reported in line with our patient safety standards, and you'll engage with regulatory agencies and external thought leaders to advance our science. You'll also serve as a key scientific resource — advising study teams, contributing to business unit and global product strategy, and supporting medical activities that help get our medicines to the patients who need them. Throughout all of this, you'll be expected to uphold the highest standards of compliance, ensuring your work aligns with applicable regulations (FDA, ICH, CPMP), Good Clinical Practices, Lilly policies, and the Principles of Medical Research.

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.
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). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
Fluent in English; both written and verbal communications
Demonstrated knowledge of drug development process
Experience of international oncology practice

Nice To Haves

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

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.
Understand and actively address the unsolicited scientific information needs of external health care professionals in compliance with local laws, global policies, and compliance guidelines.
Support data analysis and development of publications (abstracts, posters, manuscripts), slide sets, medical letters, and other medical information materials.
Participate in reporting of clinical trial data in Clinical Trial Registry activities.
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.
Support business-to-business and business-to-government activities as medical expert.
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.
Critically read and evaluate relevant medical literature; know the status and data from competitive products; keep updated with medical and scientific developments relevant to the product.
Be aware of current trends and projections for clinical practice and access in the therapeutic area(s), both near term (1–2 years) and longer term (3–5 years).
Act as scientific consultant and protocol expert for clinical study team members and others in medical.
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.