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Clinical Research Physician - Oncology

Eli Lilly and Company

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Location: Toronto, CANADA - ONTARIO Posted Date: 4/26/2013 Position Type: Full time Job Code: ELY2043BRBS Required Education: Medical Doctor Areas of Expertise Desired: Clinical Research

Description

Company Overview:

Eli Lilly and Company has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a “Best in Class” Pharmaceutical company, please review the following opportunity.



PURPOSE OF THE JOB

Through application of scientific training, clinical expertise, and relevant experience, the Clinical Research Physician (CRP) participates in the development, conduct and reporting of local clinical trials; the implementation of global clinical trials conducted in (insert country) ; 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, the CRP is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective business unit brand team(s), global Development  team, Therapeutic Area Program Phase, Early Phase Exploratory Program Medicine (EPM), and Translational Medicine team(s).  The CRP is an integral member of a business unit brand team for strategic planning in the support of launch and commercialization activities.  The CP may also work closely with global Development team(s), Therapeutic Area Program Phase, Early Phase /Exploratory Program Medicine (EPM), and Translational Medicine team(s) in new product development activities over the entire spectrum of drug development and clinical trial phases.

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. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, and the Principles of Medical Research.

 

Responsibilities Core Job Responsibilities

The primary responsibilities of the Medical Affairs CRP are generally related to late-phase and marketed compounds. The CRP is responsible for collaborating with local research staff in the planning, startup and conduct of phase 3b/4 studies that are conducted.  In addition, the CRP, if assigned is responsible for support of global Development studies conducted.  



Clinical Planning

Communicate and collaborate with Sr. Director-Medical, Regional CRP, etc. as needed.) to ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs to global Development teams, Global Health Outcomes (GHO), PRA, Therapeutic Area Program Phase, and Early Phase /EPM /Translational Medicine teams.
Communicate local/regional research needs and collaborate with other regions and the global Development team, GHO, and PRA teams to ensure Phase 3, 3b, and 4 clinical programs meet the needs of local/regional customers.
Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
Represent the clinical needs of the country/region to the business unit medical leadership in the development of clinical strategies, development plans and study protocol design.


Clinical Research/Trial Execution and Support

Review and approve local informed consent documents to ensure appropriate communication of risk to study subjects.
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).
Collaborate with Clinical Research Scientists (CRSs), regional clinical operations staff, Statisticians, health outcomes, research scientists and selected investigators in the development of protocols and data collection requirements.
Participate in investigator identification and selection, in conjunction with clinical teams.
Ensure that the clinical operations 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 the planning process and participate in study start-up meetings and other activities to provide the appropriate scientific training and information to investigators and site personnel.
Serve as resource to clinical research site monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
Review proposals and publications,
Contribute to global alignment of Phase 3b/4 clinical studies planned by country
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.
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.
Support the planning of symposia, advisory board meetings, and and/or the facilitation of other meetings with health care professionals.
Support medical information associates in preparation and review of medical letters and other medical information materials.
Support training of local medical personnel, including medical and outcome liaisons and health outcomes staff.
Prepare or review scientific information in response to customer questions or media requests.
Provide follow-up to 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.
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.
Participate in reporting of clinical trial data in Clinical Trial Registry activities.



Regulatory Support Activities

Participate in development and review of local labeling and labeling modifications in collaboration with global
Development, brand teams, regulatory, and legal.
Provide medical expertise to regulatory scientists.
Support I assist in the preparation of regulatory reports, preparation for regulatory agency advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from an affiliate/country perspective.
Participate in advisory committees.
Participate in risk management planning along with global Development team(s), business unit, local area, and Global Patient Safety (GPS).

Requirements

Basic Requirements: Education and Experience

Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in medical oncology or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
Clinical research or pharmaceutical medicine experience preferred
Knowledge of drug development process relevant to country/region preferred
Excellent English communication (written and verbal), interpersonal, organizational and negotiation skills


Additional Skills/Preferences  

Additional Information Eli Lilly Canada is committed to employment equity.  We encourage applications from qualified women, members of visible minorities, aboriginal peoples, and persons with disabilities.
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