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Clinical Research Physician

Eli Lilly and Company

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Location: Bridgewater, NJ Posted Date: 4/26/2013 Position Type: Full time Job Code: ELY1850BRBS Required Education: Medical Doctor Areas of Expertise Desired: Clinical Research

Description

Responsibilities          

Clinical Planning

Collaborate with the business unit geographical regions, Discovery, Program Phase Medicine, and Clinical Pharmacology in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.
Contribute to the Oncology 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.


Clinical Research/Trial Execution and Support

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 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 (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 clinical operations personnel / 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 corporate patient safety policies and procedures.
Review IIT proposals and publications, as requested by Sr. Director-Medical.


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.
Understand and actively address the unsolicited scientific information needs of external health care professionals according to guidelines above.
Participate in reporting of clinical trial data in Clinical Trial Registry activities.
Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
Support medical information associates in preparation and review of medical letters and other medical information materials.
Prepare or review scientific information in response to customer questions or media requests
Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.
Support data analysis and the development of slide sets and publications (abstracts, posters, manuscripts).
Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and possibly international basis.
Develop and maintain appropriate collaborations and relationships with relevant professional societies.
Support the design of customer research as medical expert
Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons and health outcomes personnel.
Provide congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events)
Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.


Regulatory Support Activities

Participate in 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 / assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
Participate in advisory committees.
Participate in risk management planning along with affiliates and Global Patient Safety (GPS).


Business/ customer support (pre and post launch support)

Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans personnel and other cross-functional management during the development of the local business plan.
Understand the scientific information needs of all Development customers (payers, patients, health care providers).
Actively address Development customer (payer, patient, and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.
Establish effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization.
Establish and maintain contact with external experts and opinion leaders; maintain a credible scientific expertise to facilitate these contacts.
Contribute as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.
Support business-to-business and business-to-government activities as medical expert.
Contribute actively on an ongoing basis to the strategic planning for the brand.
Review, offer scientific and creative support for, and approve promotional materials and tactics as needed.
Become familiar with market archetypes and potential influence on the medical interventions for the product.
Participate in PhRMA or other local or national trade associations.


Scientific / Technical Expertise and continued 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.
Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product.
Explore and take advantage of opportunities for extramural scientific experiences.
Participate in limited medical practice (volunteer).
Attend scientific symposia.

Requirements

Basic Qualifications

Medical Doctor or Doctor of Osteopathy. 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. Foreign medical graduates 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


Additional Skills/Preferences  

Clinical research or pharmaceutical medicine experience preferred
Oncology experience preferred
Experience in translational science preferred
Knowledge of drug development process preferred
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.


Additional Information

Through application of scientific training, clinical expertise, and relevant experience, the Development Clinical Research Physician (CRP) for Oncology participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of Oncology products; 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 Oncology Clinical Research Physician will also be responsible for providing medical leadership to the Biomarker program for a late stage asset. The Oncology 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, guidances (e.g. 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.



Eli Lilly and Company, Lilly USA LLC, affiliates and our wholly owned subsidiaries including ImClone Systems (collectively, “Lilly) are Equal Opportunity Employers



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