GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Division of Infectious Diseases at Massachusetts General Hospital is at the forefront of innovative clinical trials. In 2020, recognizing the need for a dedicated infrastructure, they established the Infectious Diseases Clinical Research Unit (ID CRU), led by Dr. Boris Juelg, Dr. Arthur Kim, and Diane Kanjilal, FNP. This unit serves as a vital support system, facilitating a myriad of innovative clinical trial projects led by accomplished investigators within the division. Under the stewardship of the Chief of Infectious Diseases, Dr. Ruanne Barnabas, the ID CRU has expanded its international research footprint. Dr. Barnabas brings a wealth of experience, having successfully concluded numerous international clinical trials that have catalyzed policy changes in various regions of Africa, notably addressing challenges in HPV and HIV access to care. In the year ahead, we look forward to implementing a clinical trial evaluating the efficacy of a single-dose HPV vaccination in women living with HIV, working alongside our collaborators in Rwanda, Botswana, and South Africa. In addition, Dr. Mark Siedner and colleagues are launching a Global Health Clinical Trials Working Consortium, to promote, locally designed, prioritized, and led clinical trials in the African region that address gaps in the current clinical trials funding structures through a decoloniality lens for global health. This consortium is starting with sites in Uganda and South Africa, with plans for regional distribution with projected growth.

As a Program Director, you have the unique opportunity to 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, and helping to ensure compliance with regulatory standards, managing budgets, and collaborating with cross-functional teams to achieve research and program objectives. In addition, you can actively contribute to projects 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, display intellectual curiosity, exhibit meticulous attention to detail, are highly organized, and possess 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. This commitment applies to staff members at all levels and the diverse patient populations we serve.

Current project examples include:

* 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 longstanding inequities in clinical trial design, prioritization and leadership

APPLICATION PROCESS

**When applying, please upload a cover letter and resume. Applications that do not include both components will NOT be considered.**

PRINCIPAL DUTIES AND RESPONSIBILITIES:

In collaboration with Dr. Barnabas, Infectious Diseases Clinical Research Unit Leadership, and Physician investigator(s), the Program Director is responsible for the following activities, including but not limited to:

Strategic Planning

* 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 consortium

Program Research Management

* Oversee all aspects of the clinical research program, including project intake, start-up operations, project management, ongoing study progress, and study closeouts

* Develop 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

Staff Supervision

* Directly supervise research assistants, project managers, data analysts, and programmers, including:

o Develop curriculum and deliver new employee training,

o Provide daily oversight and direction,

o Meet weekly with research team members,

o Facilitate career development opportunities,

o Lead 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.

Fiscal Oversight

* 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.

Research (Optional)

* 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 preferred

DESIRED SKILLS/ ABILITIES/ COMPETENCIES:

Planning, Organizing, and Coordinating

* Skilled 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.

Team Management

* 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.

Gets Results/Takes Initiative

* 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.

Communication Skills

* 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 approach

Analytical Skills

* Intellectual curiosity and willingness to learn.

* Rigorous academic and/or professional background, including healthcare work.

* Basic familiarity with health outcomes/epidemiology research and/or clinical trials

This 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.

WORKING CONDITIONS:

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.

SUPERVISORY RESPONSIBILITY:

The candidate will be responsible for providing daily supervision, guidance, and expertise for the research team.

The above is intended to describe the general contents and requirements of work being performed by people assigned to this classification. It is not intended to be construed as an exhaustive statement of all duties, responsibilities or skills of personnel so classified.

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.