Clinical Research Physician-Exploratory Medicine & Pharmacology
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JOB TITLE:Clinical Research Physician (CRP) *
BUSINESS UNIT OR AREA:Exploratory Medicine & Pharmacology (EMP)
SALARY CLASS PROGRESSION:R3 through R8
PURPOSE OF THE JOB
Through the application of scientific and medical training, clinical expertise and relevant clinical experience, the Exploratory Medicine & Pharmacology (EMP) Clinical Research Physician (CRP) participates in the following: the development, conduct and reporting of clinical trials for new compounds, the implementation of 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, grant submissions and contracts, contracts with regulatory and other governmental agencies. The CRP 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 are in compliance with current local and international regulations, laws, guidance (e.g. NMPA, ICH, FDA and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision.
Core Job Responsibilities
The primary responsibilities of EMP CRP are generally related to clinical pharmacology including early phase exploratory and bridging studies for China submission.
The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.
- Contribute to the development of the overall strategy and clinical plan for affiliate development of clinical compounds, focusing on studies required for regulatory submission. Support preparation of high-level plan for phase 2 and phase 3 studies for early phase to support submission.
- Collaborate with other scientist (e.g., PK/PD, statistics, ADME, modeling and simulations) to integrate study development.
Clinical Research/Trial Execution and Support
- Design and oversee implementation of all clinical pharmacology studies. Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and patient groups.
- Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research.
- Design, create, and provide oversight for protocol development.
- Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements.
- Collaborate with local clinical research staff, statisticians and selected consultants and/or investigators in the development of protocols, and data collection requirements.
- Participate in investigator identification and selection, in conjunction with the clinical pharmacology clinical operation group.
- Review and provide input to risk profiles and local informed consent documents as required, ensuring appropriate translation and communication of risk to study subjects.
- Provide oversight ensuring that operational team has documented the completion of administrative requirements for study initiation and conduct i.e., 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 meetings and other activities to provide the appropriate training and information to investigators and site personnel.
- Serve as resource to CTMs/clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
- Understand and actively address the scientific information needs of all investigators and personnel.
- Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with global patient safety policies and procedures.
- Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration with global patient safety.
- Provide appropriate oversight and partnership with Third Party Organizations to ensure successful study execution.
Scientific Data Dissemination/Exchange
- Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers.
- Address the unsolicited scientific questions and information needs of external health care professionals according to guidelines above.
- Participate in reporting of clinical trial data in Clinical Trial Registry activities.
- Partner with scientific communications staff on publication strategy and process.
- Prepare and present documentation of clinical trials results to corporate committees, regulatory agencies, and other external agencies.
- Publish results of research projects as appropriate.
- Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
- Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications for clinical pharmacology trials.
- Provide clinical reports for local and international regulatory purposes.
Regulatory Support Activities
- Support/assist in the preparation of regulatory reports, including ethnic sensitivity assessment, the medical sections of the IND for early clinical pharmacology studies, preparation of authority advisory committees’ regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response.
- Develop and review labeling modifications in collaboration with regulatory and safety groups.
- Provide medical and clinical pharmacology expertise to regulatory scientists.
Business/customer support (pre and post launch support)
- Understand the scientific information needs of all Clinical Pharmacology customers (regulators, clinical researchers, health care providers, patients, payers).
- Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national, regional, and possibly international basis.
- Develop and maintain appropriate collaborations and relationships with relevant professional societies, and scientific and medical organizations on local and possibly international scale.
- Actively address customer (regulators and other clinical scientists) questions in a timely fashion by leading data analyses and new clinical research efforts.
Scientific/Technical Expertise and continued development
- Contributes to the development and identification of biomarkers and methods to support drug development.
- Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product.
- Knowledge of current trends and projections for clinical practice and access in the therapeutic area relevant to the product.
- Explore and take advantage of opportunities for extramural scientific experiences
- Attend scientific symposia
- Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule
- Maintain awareness of current clinical practices through experience or contacts
- Actively set and meet individual professional development goals and contribute to the development of others by being an active source of coaching and feedback to co-workers
- Actively participate in recruitment, diversity, and retention efforts
- Participate in committees, Six Sigma initiatives and task forces as requested by local/corporate management
- Support Due Diligence activities as requested.
- Model the leadership behaviors outlined in the “On Leadership” White Paper
- Be an ambassador of both patients and the Lilly Brand
- 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.
- Minimum 2 years’ experiences of clinical research in pharmaceutical industry
- Knowledge of drug development process
- Fluent in English; both written and verbal communications
- Interpersonal, organizational and negotiation skills
- Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
- Excellent teamwork skills
- Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
OTHER INFORMATION-role will require interaction with many of the following:
- Therapeutic area physicians, brand physicians, early phase physicians, and directors-medical
- Patient safety physician
- PK/PD, Modeling & Simulation, ADME, Toxicology
- Regulatory directors, scientists, and associates
- Portfolio & Project Management
- Clinical research staff (trial management, site management, data management)
- Legal counsel
- Scientific and clinical experts, thought leaders
- Clinical investigators
- Practicing physicians/prescribers
- Regulatory agency personnel
- Professional association staff and leaders
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly 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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-2557.
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.
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