Overview
Program Director-(3289247)
Description
The Division of Infectious Diseases at Massachusetts General Hospital is at the forefront of innovative clinical trials. In 2020, they established the Infectious Diseases Clinical Research Unit (ID CRU) to support a wide range of clinical trial projects led by investigators within the division. Under the Chief of Infectious Diseases, Dr. Ruanne Barnabas, the ID CRU has expanded its international research footprint, with upcoming projects including a clinical trial evaluating a single-dose HPV vaccination in women living with HIV, with collaborators in Rwanda, Botswana, and South Africa. Dr. Mark Siedner and colleagues are launching a Global Health Clinical Trials Working Consortium to promote locally designed, prioritized, and led clinical trials in Africa, with initial sites in Uganda and South Africa and plans for regional growth.
As a Program Director, you will assist with the strategic planning, implementation, and management of building these international research programs. This role involves overseeing multiple research projects, helping to design and implement global clinical trials research strategy and initiatives, ensuring regulatory compliance, managing budgets, and collaborating with cross-functional teams to achieve research and program objectives. You may also contribute as a researcher and / or leader in establishing and promoting decolonization strategies for global clinical trials work if you are interested.
Our team seeks individuals who embody a mission-driven ethos, intellectual curiosity, meticulous attention to detail, high organization, and a deep understanding of the international clinical trial process. A sense of humor is a must. We are committed to fostering, cultivating, and preserving a diversity, equity, and inclusion culture across staff and patient populations we serve.
- Evaluating delivery methods for optimizing pre-exposure prophylaxis (PrEP) access in South Africa.
- An observational study evaluating the clinical impact of a policy change to allow stable HIV patients to pick up medications at community venues in South Africa.
- Investigation of the role of maternal HIV infection and co-infection with early childhood infections.
- Convening global clinical trial leaders to establish a consortium of clinical trials in the African region to address inequities in clinical trial design, prioritization and leadership.
- When applying, please upload a cover letter and resume. Applications that do not include both components will NOT be considered.
In collaboration with Dr. Barnabas, Infectious Diseases Clinical Research Unit Leadership, and Physician investigators, the Program Director is responsible for the following activities, including but not limited to :
Work with ID division and ID CRU leadership to formulate and implement strategic approaches to ensure a successful international program in alignment with divisional goals and objectives.Lead and inspire cross-functional project teams, fostering a collaborative and high-performance culture.Effectively communicate program goals, expectations, and updates to internal and external stakeholders.Coordinate with key stakeholders, including investigators, vendors, and regulatory agencies.Co-lead the development, design, implementation and oversight of a global South clinical trials consortiumOversee all aspects of the clinical research program, including project intake, start-up operations, project management, ongoing study progress, and study closeoutsDevelop comprehensive project timelines, budgets, and deliverables in collaboration with cross-functional teams.Coordinate all administrative aspects of multiple active and pending projects.Throughout project duration, plan, track, and report on project tasks, responsible parties, timelines, etc.Proactively take steps to help others move forward, delegate project tasks among the project team, hold project-specific meetings, bring in additional resources as needed, etc.Implement and maintain rigorous quality control measures throughout the clinical trial lifecycle.Conduct regular regulatory reviews and audits to ensure Good Clinical Practice (GCP) compliance with quality standards.Serve as a liaison between team members at various US and international collaborative research sites and interface with sponsors / funders on behalf of the PI, as needed.Coordinate and monitor the Institutional Review Board and other relevant regulatory applications across all projects, including all applicable review dates and deadlines, to prevent lapses in approval.Assist with creating and maintaining unit SOPs, study templates, workflows, and databases.Provide updates to senior management on program status, progress, and potential risks.Ensure research integrity, including data documentation and management, by developing best practices, providing ongoing training, and monitoring adherence.Manage and participate in collaborative grant-writing projects and protocol development.Take administrative leadership role in organization, design, and convening of global trials consortium members.Partner with global clinical trial research sites to establish standards, assist in infrastructure development and curriculum design to promote GCP and local regulatory standards compliance.Directly supervise research assistants, project managers, data analysts, and programmers, including :oDevelop curriculum and deliver new employee training,oProvide daily oversight and direction,oMeet weekly with research team members,oFacilitate career development opportunities,oLead annual performance review process.Facilitate recruitment efforts at in-country sites by participating in job description development, posting employment opening advertisements in setting-appropriate channels, screening applicants, and interviewing selected candidates.Ensure protocol budgets are maintained and meet study milestones.Oversee and manage the procurement of study and staff supplies.Assist with protocol budget development and amendments.Contribute directly to and / or lead scientific analysis, abstract submissions, and manuscript development for 1-2 projects at a time.Qualifications
Job qualifications include the following :8+ years of experience in an academic, clinical research, or related setting.Experience in international research settings is required.Bachelor’s degree required; Master’s degree in public health, public policy, management, or related field strongly preferredSkilled in identifying opportunities to improve the efficiency of research operations and subsequently execute improvements.Time management skills with the capability to prioritize among multiple requests from multiple individuals and the ability to change direction in response to a fluctuating work environment.Strong leadership and interpersonal skills.Ability to work successfully in a collaborative environment.Ability to manage diverse teams with different skillsets, work styles, and professional roles.High personal work standards and a sense of urgency about results.Ability to anticipate the needs of the group in a fast-paced environment.Problem-solving ability, including gathering information, identifying resources, and imagining alternatives.Demonstrates initiative and identifies key priorities, even in ambiguous situations with limited direction.Ability to work effectively under pressure and within short time constraints.Consistently demonstrates a positive, "can-do" attitude.Excellent written and verbal communication skills.Ability to represent the Division with the utmost professionalism and ability to build strong relationships inside and outside the group.Ability to clarify and distill complex issues to a variety of stakeholders.Cognizant and respectful of cultural differences in communication approachIntellectual curiosity and willingness to learn.Rigorous academic and / or professional background, including healthcare work.§Basic familiarity with health outcomes / epidemiology research and / or clinical trialsThis description has been designed to indicate the general nature and level of work performed by an employee within this position. The actual duties, responsibilities, and qualifications may vary based on need.Duties will be carried out in a typical office environment, and occasional evening or weekend work may be required.Travel to international research sites will be required. There is also the opportunity to travel to scientific meetings to present research.The candidate will be responsible for providing daily supervision, guidance, and expertise for the research team.EEO Statement
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives, and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.
Primary Location
: MA-Boston-MGH Main Campus
Work Locations
: MGH Main Campus 55 Fruit Street Boston 02114
Job
: Professional / Managerial
Organization
: Massachusetts General Hospital(MGH)
Schedule
: Full-time Standard Hours : 40
Shift
: Day Job
Employee Status
: Regular Recruiting Department : MGH Infectious Disease
Job Posting
: May 9, 2024
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