Clinical Research Physician - Development

Location: Indianapolis

Clinical Research Physician - Development page is loaded## Clinical Research Physician - Development locations:
US, Indianapolis INtime type:
Full time posted on:
Posted Todayjob requisition :
R-98918

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.
** Organization Overview
** At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
** Responsibilities
* * Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Development Clinical Research Physician (CRP) participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts;

contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization. The CRP serves as a scientific resource for study teams, departments, and others as needed.

The Clinical Research Physician must be aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.  Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

The primary responsibilities of the Development CRP will be related to late-phase clinical trials within the Cardiovascular Pillar. In particular, the role will serve as Lead Study Physician for one of our Lp(a) platform Phase 3 CV Outcome Trials.

The core job responsibilities may include those listed below as deemed appropriate by line management, as well as all other duties as assigned.

Clinical Planning
* 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.
* 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
* Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports) according to the agreed upon project timeline.
* Provides oversight and input into Informed Consent Documents (ICD).
* Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, 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 that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
* Assist in planning process and participate in study start-up…