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Position Objective: Provide services as a Medical Officer in support of the overall functions of the National Cancer Institute (NCI) within the National Institutes of Health (NIH). To provide guidance on the background justification for the scientific objectives and medical safety of the trials supported by CTEP, the interaction between the regulatory aspects of clinical trial agreements and terms for trials with pharmaceutical collaborators and extramural investigators, and comment on the content and provide feedback on specific concerns by the extramural investigators as well as the extramural sites subject to the medical/scientific and policy requirements of the specific CTEP-supported clinical trials that they participate in. In addition, this physician consultant may offer guidance on other DCTD initiatives that affect its clinical trials network programs.

Duties and Responsibilities:

• Review and provide comments on clinical trial proposals or modifications to approved or active CTEP-funded trials as requested.

• Collaborate with CTEP staff to train and assist staff on the design and conduct of clinical treatment trials in oncology.

• Provide scientific and regulatory expertise in oncology drug development, symptom management and clinical oncology.

• Provide expert guidance on CTEP regulatory guidelines for clinical trials. 1

• Review clinical trial protocols and provide comments as for safety and operational issues with protocols. Review, comment on, and accept or reject for clinical protocols for implementation.

• Collaborate with staff on the review, planning and implementation of clinical trials and ensure all concerns are addressed. 3

• Provide subject matter expertise during protocol development.

• Provide support for extramural research program, including epidemiologic studies, clinical trials and other basic and clinical studies.

• Work with staff on protocol development; provide input on study safety design; identify medical and logistical problems that may impede the study; conduct reviews of clinical protocols and all supporting documents; and provide feedback to staff and clinical investigators.

• Provide clinical expertise to assist in developing Investigational New Drug (IND) applications. 2

• Participate in clinical trial decision on selection and implement of interventions, review of clinical outcomes, and assurance of participant safety.

• Formulate internal policies concerning Extramural research policy and priorities; advise management on the direction of research efforts.

• Provide scientific and regulatory expertise in drug development for symptom management clinical trials.

• Write policies and guidelines on safety related issues for research studies.

• Provide a review and response to protocol amendments; write, review and edit materials following group discussion on research and scientific protocol.

• Review pertinent literature to provide a scientifically rigorous review of the subject matter. Participate in discussions of and prepare written summaries of evaluations of clinical trial concepts.

• Analyze data from clinical trials and research investigations; prepare abstracts for submission and manuscripts for publication.

• Write policies and guidelines on safety related issues for research studies.

• Provide a review and response to protocol amendments; write, review and edit materials following group discussion on research and scientific protocol.

• Review pertinent literature to provide a scientifically rigorous review of the subject matter.

• Analyze data from clinical trials and research investigations; prepare abstracts for submission and manuscripts for publication.

• Take part in site visits to review and assess medical issues.

• Provide medical expertise in protocol follow-up stages for subject safety and protection. Assess serious adverse events from clinical trials.

• Review safety reports and represent the Program as a safety expert on safety committees.

• Preview serious adverse event (SAE) reports; provide expert medical advice for potential impact of SAEs on ongoing research.

• Participate in clinical trial Steering Committee decisions on selection and implementation of interventions, review of clinical outcomes and assurance of participant safety.

• Review and provide recommendations on the design and safety of clinical trials that represent the Program in communication with stakeholders while developing and implementing clinical trials.

• Review clinical trial protocols.

• Advise program management on merits and deficiencies of proposed clinical studies. 4

• Administer clinical and basic research projects, including clinical trials; monitor progress and conduct of projects, including protection and safety of participants in clinical trials.

• Assess serious adverse events from clinical trials. 5

• Provide medical expertise in protocol follow-up stages for subject safety and protection.

• Preview serious adverse event (SAE) reports; provide expert medical advice for potential impact of SAEs on ongoing research.

• Provide clinical expertise to assist in developing Investigational New Drug (IND) applications. Evaluate annual IND annual reports for medical safety; report findings.

• Serve as an expert medical resource to staff and investigators.

• Participate in clinical trial decision on selection and implement of interventions, review of clinical outcomes, and assurance of participant safety.

• Provide administrative actions on grant applications and funded projects; develop effective solutions to emerging or unforeseen challenges to program development of administration.

• Collaborate on the planning, development, implementation and administration of research and training programs, projects, and contracts, conferences and workshops.

• Participate in clinical trial Steering Committee decisions on selection and implementation of interventions, review of clinical outcomes and assurance of participant safety.

• Attend and participate in scientific meetings and conferences.

• Work products and documents related to managing and coordinating standard operating procedures across CTEP related to the efficient and effective conduct of CTEP-supported clinical trials. - Ad-Hoc

• Work products and documents related to setting new guidelines and standards for conduct of clinical trials. - Ad-Hoc

• Work products and documents related to ongoing decision-making to facilitate optimal progress of trials; provide advice and guidance to scientists, pharmacists, informaticians that will assist them in assuring a well-coordinated and optimally functioning clinical trials support service for the conduct of CTEP-supported clinical trials. - Ad-Hoc

• Work products and documents related to development of an online site that captures, maintains and updates all the pertinent CTEP Branch SOPs for the conduct of clinical trials. - Ad-Hoc

  Basic Qualifications:

• Medical doctorate required.

• Licensed physician or board eligible.

• Board certified in oncology.

• Skilled in Microsoft Office, SharePoint, and Outlook.

• Experienced in clinical research, medical training, data management, and oncology experience.

• Expertise in clinical trial design and conduct, especially with respect to biomarker-driven, precision medicine oncology treatment trials .

• Expertise in FDA regulatory requirements related to conduct of clinical treatment trials in oncology preferred.

• Must possess knowledge and expertise in the drug development process and policies .

• Must possess extensive experience in reviewing pre-clinical and clinical research data supporting the research objectives in clinical treatment trials in oncology.

  Minimum Qualifications:

• Ability to multi-task and pay close attention to detail.

• Excellent analytical, organizational and time management skills.

• Strong communication skills, both oral and written.

  *This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job us at recruiting@gapsi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

  GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

  This position is contingent upon contract award.

Requisition ID: 6499