Medical Officer For Nci Dctd Ctep Cib

Job Family:
Physicians (Digital)
Travel Required:
None
Clearance Required:
Ability to Obtain Public Trust
What You Will Do:
We are currently searching for a Medical Officer for the NCI DCTD CTEP CIB. The Clinical Investigations Branch (CIB) in NCI/DCTD facilitates and organizes clinical research including surgical and radiation therapy, as well as chemo, biologic immune-no-therapies in the treatment of cancer in specific disease areas for adult, adolescent, pediatric cancer patients. CIB coordinates and oversees the NCI's National Clinical Trials Network Program (NCTN); and collaborates with NCTN groups, consortia, cancer centers in the development/harmonization of research standards and methodologies. CIB oversees pediatric drug development, from the testing of novel agents through the Pediatric Preclinical Testing Consortium (PPTC) to clinical evaluations of novel agents by CIB supported pediatric clinical trials organizations. This is a full-time, on-site opportunity in Rockville, MD.

• Participate on calls with CTEP staff to provide guidance to extramural investigators on clinical trials being proposed and developed for conduct under the CTEP clinical trials network programs in specific cancer disease areas.
• Review and provide comments on clinical trial proposals or modifications to approved or active CTEP-funded trials in
• specific cancer disease areas as requested.
• Participate on NCI Disease-Specific Steering Committees and Task Forces via phone calls and in-person meetings regarding CTEP clinical trial proposals and the conduct of approved CTEP clinical trials.
• Review and provide guidance on policies and procedures supporting DCTD special clinical trial initiatives.
• Assist the CTEP staff in interacting with extramural investigators and pharmaceutical partners to develop novel collaborations in specific disease areas.
• Provide advice on the oversight of clinical trials and protocols.
• Provide scientific and regulatory expertise in oncology drug development, symptom management and clinical oncology.
• 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.
• 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.
• 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.
• Formulate internal policies concerning Extramural research policy and priorities; advise management on the direction of research efforts.
• Review and provide recommendations on the design and safety of clinical trials that represent the Institute in communications with the FDA, sponsors and academia partners while developing and implanting clinical trials.
• Participate in discussions of and prepare written summaries of evaluations of clinical trial concepts.
• 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.
• Review safety reports and represent the Program as a safety expert on safety committees.
• 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.
• 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.
• 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.
• Attend and participate in scientific meetings and conferences./
• 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.

#SOAR
What You Will Need:

• Licensed physician or board eligible
• Bachelors Degree
• Oncology Experience required.
• Must possess an active US License to practice medicine in a clinical oncology area (e.g., medical oncology, hematology-oncology, pediatric oncology, radiation oncology, surgical oncology)
• At least five (5) years of experience

What Would Be Nice To Have:

• Board certification in a clinical oncology area preferred.
• Clinical research
• Possess knowledge and expertise in the drug development process and policies.
• Possess extensive experience in reviewing pre-clinical and clinical research data supporting the research objectives in clinical treatment trials in oncology.
• Expertise in clinical trial design and conduct, especially with respect to biomarker-driven, precision medicine oncology treatment trials preferred.
• Experience with FDA regulatory requirements related to conduct of clinical treatment trials in oncology preferred.
• Medical training
• Microsoft Office
• SharePoint
• Outlook
• Written and Oral Communication Skills

What We Offer:
Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
Benefits include:

• Medical, Rx, Dental & Vision Insurance
• Personal and Family Sick Time & Company Paid Holidays
• Parental Leave
• 401(k) Retirement Plan
• Group Term Life and Travel Assistance
• Voluntary Life and AD&D Insurance
• Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
• Transit and Parking Commuter Benefits
• Short-Term & Long-Term Disability
• Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
• Employee Referral Program
• Corporate Sponsored Events & Community Outreach
• Care.com annual membership
• Employee Assistance Program
• Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
• Position may be eligible for a discretionary variable incentive bonus

About Guidehouse
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.
If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.
Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.