Clinical Research Physician - Medical Affairs

0-2 years

Not Disclosed

Indianapolis

10 March 24, 2025

Job Description

Job Type: Full Time Education: MD/DO Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Physician - Medical Affairs
Location: Indianapolis, Indiana, United States of America
Category: Medical
Job Type: Full Time, Regular
Job Id: R-80290

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.

Compensation:
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $198,000 - $336,600.

Clinical Research Physician – Medical Affairs

Through the application of scientific and medical training, clinical expertise, and relevant clinical experience, the Business Unit Medical Affairs, Rheumatology – Immunology Clinical Research Physician (CRP) is an integral member of the medical affairs and business unit team for strategic planning in the support of launch and commercialization activities to meet patients' needs and ultimately enhance the customers' experience in interacting with the company. The definition of "customer" here includes patients, providers (HCPs), and payers.

The CRP may also work closely with global Development teams, Therapeutic Area Program Phase, Early Phase/Clinical Pharmacology, and Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical trial phases. Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility; the implementation of global clinical trials conducted in local affiliates/countries; the reporting of adverse events as mandated by corporate patient safety; 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; the outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization.

In addition, with input from the Director – Medical and Business Unit Team Physician/Regional Medical Leader, the CRP is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective business unit global Medical Affairs team, brand team(s), global Development team, Therapeutic Area Program Phase, Early Phase, and Translational Medicine team(s).

The Clinical Research Physician plays a crucial role in supporting the launch and commercialization of new products in the therapeutic area, ensuring alignment with strategic priorities. They provide expert medical and scientific guidance, contribute to the development of clinical and medical plans, and oversee the implementation of global clinical trials. Their responsibilities also include addressing scientific information needs, developing medical strategies for brand commercialization, and supporting business-to-business and business-to-government activities as a medical expert.

The Clinical Research Physician serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Physician is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP, etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, 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 responsibility of the Global Medical Affairs, Rheumatology – Immunology Clinical Research Physician (CRP) is to provide expert medical support to all aspects of the business, to ultimately enhance the customers' experience in interacting with the company. This includes:

Marketed product support (participate in the strategic plan for the compound)
Leading in scientific data generation and dissemination (leading and presenting at conferences, advisory boards, etc.)
Overseeing the development of the scientific content of educational programs
Medical support for regulatory affairs and interactions with government agencies
Medical support for pricing, reimbursement, and access (PRA) (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed)

These responsibilities are generally related to late-phase and marketed compounds but can also include early-phase trials (for example, phase I and II trials).

Scientific Data Dissemination/Exchange:

Participate in data analyses, development of scientific data dissemination, and preparation of final reports and publications.
Support the planning of symposia, advisory board meetings, and/or the facilitation of other meetings with healthcare professionals.
Oversee the development of the scientific content of educational programs and medical content strategy.

Clinical Planning:

Communicate and collaborate with Director-Medical and Business Unit Team Physician/Regional Medical Leader as needed to ensure life cycle plans for drugs in development address customer needs.
Collaborate with other regions and global Development and Medical Affairs teams to ensure clinical programs meet local/regional customer needs.

Clinical Research/Trial Execution and Support:

Collaborate with clinical research staff in the design, conduct, and reporting of local clinical trials.
Assist in planning and participating in study start-up meetings and other activities to provide scientific training and information to investigators and site personnel.

Regulatory Support Activities:

Participate in development and review of local labeling and labeling modifications in collaboration with global Development, brand teams, regulatory, and legal.

Scientific/Technical Expertise and Continued Development:

Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product.

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Clinical Research Physician - Medical Affairs

Job Description

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