Tuesday, September 3, 2013

Job Post: Oncology Clinical Research Physician

Job Post: Oncology Clinical Research Physician


The Oncology Clinical Research Physician (CRP) will combine scientific and clinical expertise with his/her passion for helping cancer patients to make meaningful differences to the lives of many people. He/she helps create solutions for patients, health care professionals, and caregivers that have broad impact across the world.

He/She participates in the development, conduct and reporting of local clinical trials; the implementation of global clinical trials ; the reporting of adverse events as mandated by corporate patient safety; review process for protocols, study reports, publications and data dissemination for products; medical outreach, and various medical activities in support of demand realization.

The CRP is an integral member of the Oncology brand team for strategic planning in the support of launch and commercialization activity and may work with 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.

Core Job Responsibilities

The primary responsibilities of the Oncology 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. The core job responsibilities include those listed below as well as all other duties as assigned.

Clinical Planning

• Ensure life cycle plans for drugs in development address customer needs or communicate and collaborate such needs as delegated by Sr. Director-Medical 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.
• Represent the clinical needs of the country/region 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.
• Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials.
• 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 and local laws and requirements.
• Assist in the planning process and participate in study start-up meetings.
• Serve as resource to clinical research site monitors, investigators and ethical review boards.
• Review IIT proposals and publications.
• Contribute to global alignment of Phase 3b/4 clinical studies.
• 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.
• Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
• Participate in reporting of clinical trial data.

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 / 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 responses.
• Participate in advisory committees and risk management planning.

Business/ customer support (pre and post launch support)

• Understand the scientific information needs of all local/regional customers.
• Actively address customer (payer, patient and health care providers) questions in a timely fashion by leading data analyses and new clinical or health outcomes research efforts.
• Contribute to the development of medical strategies to support brand commercialization activities by working closely with brand teams, global PRA and HO, clinical management or personnel and other cross-functional management during the development of the local business plan.
• Contribute as a scientific and medical expert to activities and deliverables of the PRA organization.
• Support business-to-business and business-to-government activities as medical expert.
• Contribute actively on an ongoing basis to the strategic planning for currently marketed brands.
• Review, offer scientific and creative input, and approve promotional materials for brand team.
• Support training of sales representatives, and other medical representatives.
• Become familiar with market archetypes and potential influence on the medical interventions.
• Participate in local or national trade associations.

Scientific / Technical Expertise and continued development

• Be aware of current trends and projections for clinical practice and access in the therapeutic area(s).
• 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.
• Attend, contribute and participate in medical congresses/scientific symposia.

General Responsibilities

• Support the business unit management team.
• Set and meet individual professional development goals and contribute to the development of others.
• Model the leadership behaviors.
• Be an ambassador for the Brand.

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.
• 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
• Excellent English communication (written and verbal), interpersonal, organizational and negotiation skills
• Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
• Demonstrated leadership and teamwork skills.
• Clinical and clinical trial expertise in breast cancer.
• Experience with lecturing, teaching, and/or writing about breast cancer.

Additional Skills/Preferences
• Translational research experience (e.g. biomarkers), particularly in breast cancer.
• Knowledge of the drug development process, particularly within the US.
• Pharmaceutical medicine experience.

To learn more about this position, contact: Paul Kim by email: paul.s.kim@us.ibm.com

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