Research Program Leader, Senior
Immunology Clinical Research
Lead the strategic startup of the Duke Cancer Institute’s [DCI] Center for Cancer Immunotherapy [the Center]. Requires extensive knowledge in basic science, correlative sciences and clinical research.The Center will work across the DCI’s many clinical research teams to shepherd the development of research concepts and clinical trials with Duke and DCI wide education. The goal of this program is business development, investigator initiated trials [IITs], initiating funding applications, and developing manufacturing and support for cellular products.
The position works directly with Dr. Scott Antonio to develop the Center. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.
Operations, Study and Site Management
In collaboration with the Principal Investigator [PI] and lead study feasibility, design, protocol development, and recruitment and retention strategies. Implement cultural diversity and competency in study design and conduct. Develop and implement protocol-specific systems including process flows, training manuals, standard operating procedures, study documentation and case report forms.
Provide oversight and training regarding subject screening, consent, regulatory compliance and documentation; including sponsorship and participation in trials. Manage research and financial resources.
Oversee development of safety and security documents such as research data storage plans [RDSP], conflict of interest [COI], and data safety management plans [DSMP]. Serve as the expert resource and oversee the Institutional Review Board [IRB] process including documents and communication.
Be familiar with intellectual property rights, inventions patents, and technologies. Understand regulations related to investigational products with sponsors. Ensure research is coordinated appropriately with Duke Core services such as Investigational Drug Service [IDS] and Biobank. Manage agreements such as Material Transfer and Investigational New Drug Applications.
Oversee site initiation, closeout and document storage.
Lead development of policies, guidance, reporting and documentation for monitoring, audits, adverse events and research specimens. Lead and train compliance with institutional requirement and policies including sponsor specific.
Conduct and synthesize literature reviews independently. Collaborate with stakeholders [statistical, operational, etc.] to ensure adequate design, implementation and testing of study aims and protocols. Develop research proposals and protocols independently. Summarize and interpret study results; determine and implement improvements for future studies.
Detect issues related to data capture, collection or management; design and implement improvements.
Lead the required processes, policies, and systems to ensure data security and provenance. Lead the creation of electronic case reporting forms, electronic data capture systems, technologies and software to ensure the highest quality data collection and capture. Develop the systems and framework for quality assurance and security.
Collaborate and communicate with PI, DCI and institutional leadership, and study teams as required. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions.
Represent the CCI’s research activities at the institution level.
Lead team meetings, committees, task forces and ad hoc groups at the department and institution level. Lead cross-functional committees charged with improving study design. Provide significant contributions to research and projects across multiple groups. Independently lead scientific, programmatic presentations and publications.
Define the vision and direction of the research team, lead and supervise staff. Model the DCI’s core value “Cancer Care as It Should Be” for staff. Create a team culture that fosters open communication, motivates staff, and encourages creativity. Seek out, listen to, accept and act on feedback. Establish regular communication methods and meetings with staff; collectively and individually. Be available to staff on a routine basis to provide leadership and mentoring.
Provide staff with clear measureable goals, monitor performance and quality of work. Assign staff duties and responsibilities; cross-train and reassign as needed to effectively conduct clinical research. Foster and encourage the professional development of staff. Oversee staff training and certifications to ensure compliance with standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research.
Serve as an expert resource for colleagues and research team.
Articulate the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria to the department. Provide departmental-wide training in the ethical conduct of research. Serve as the departmental expert resource in study design to ensure inclusion of safeguards, protection of vulnerable populations and ethical conduct standards.
Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
Know and follow policies, standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research. Maintain Duke and project specific training and certification requirements.
Cancer Center for Immunotherapy
Work closely with DCI and CCI leadership in strategic planning, including facilitation of annual strategic planning meetings. Manage the logistical and financial support for meetings, seminars and retreats.
Other work as assigned.
Job Code 1281 RESEARCH PROGRAM LEADER, SR
Requisition Number 401604899
Duke Entity MEDICAL CENTER
Job Family Level 69
Full Time / Part Time FULL TIME
Regular / Temporary Regular
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging.
Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Completion of a Bachelor's degree
Work requires a minimum of eight years of research experience (e.g., research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related experience.
Can easily use computing software and web-based applications [e.g., Microsoft Office products and the electronic medical record].
- Excellent leadership, negotiation and organizational abilities.
- Excellent interpersonal skills to develop and enhance relationships to effectively collaborate and communicate with diverse communities to move projects forward.
- Excellent written and verbal communication skills.
- Excellent judgment and decision making skills.
- Excellent analytical ability and innovative problem solving skills.
- Ability to effectively manage and prioritize competing projects.
- Knowledge of basic science, correlative sciences and clinical research.
The preferred candidate will have experience in research, regulatory, basic science or correlative science.
Experience in scientific writing, administration or manufacturing products. Experience working with a diverse portfolio of disease groups.
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