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Duke University:

Duke University was created in 1924 through an indenture of trust by James Buchanan Duke. Today, Duke is regarded as one of America's leading research universities. Located in Durham, North Carolina, Duke is positioned in the heart of the Research Triangle, which is ranked annually as one of the best places in the country to work and live. Duke has more than 15,000 students who study and conduct research in its 10 undergraduate, graduate and professional schools. With about 40,000 employees, Duke is the third largest private employer in North Carolina, and it now has international programs in more than 150 countries.

Research Director, Medical Product Development and Regulatory Policy

Robert J. Margolis, MD, Institute for Health Policy

The Robert J. Margolis, MD, Institute for Health Policy at Duke University (Duke-Margolis) seeks to address critical health policy challenges and improve health, health equity, and the value of health care through practical, innovative, and evidence-based policy solutions. The interdisciplinary nature of Duke-Margolis brings together policy experts, researchers, health care professionals, and students from across Duke's schools of medicine, nursing, law, public policy, business, and engineering, and fosters extensive relationships with stakeholders both internal and external. These relationships span foundations, private sector organizations, state and federal governments, and global entities. The Institute fosters excellence, leadership, and scholarship at every level.

Occupational Summary

Duke-Margolis has an opening for a Research Director to join its Biomedical Innovation team.

This position leads the strategic design, management, and direction of the health policy program area within Duke-Margolis focused on the development and regulation of medical products. The Research Director is responsible for oversight and direction of a portfolio of projects within this area that are managed either personally or by staff supervised by the individual in this role. The Research Director is a subject matter expert across a range of dynamic FDA regulatory policy areas including early-stage clinical development, clinical trial modernization, medical product review processes, innovative manufacturing, and data analysis and surveillance. The role entails regular interaction with an array of external project sponsors and collaborators including government agencies, academic centers, advocacy organizations, medical product developers and manufacturers, health care organizations, and technology and AI companies. The individual collaborates with Duke-Margolis executive leadership and manages implementation of research and policy objectives to contribute to successful execution of the Institute's strategic goals. The Research Director has significant responsibility for cultivation of funding opportunities and management of program area personnel.

Duke-Margolis has offices in both Washington, DC and on Duke's main campus in Durham, NC. Washington, DC is the preferred location for this position as substantial components of the work will be in-person in the DC area, though exceptional NC candidates willing to travel may be considered. Employees are currently working in a hybrid capacity with a combination of teleworking locally to the base office area (DC/MD/VA or NC, respectively) and in-person team collaboration days.

Work Performed

Program and Research Leadership

Collaborate with the Duke-Margolis leadership team, Institute faculty, and senior researchers to develop project direction, focus, priorities, and strategies to meet the research and project needs within a program area in the Biomedical Innovation workstream. Manage execution.

Recognized as a context expert in specific area(s) of expertise, specifically in areas of medical product development and regulatory policy. Areas of particular focus include early-stage clinical development, clinical trial modernization, medical product review processes, innovative manufacturing, and data analysis and surveillance with an emphasis on FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Provide content leadership and direct project staff in substantive content components of work products.

Interact closely with external collaborators including government agencies, research and/or policy organizations, industry, trade associations, patient groups, health system or health care organizations, technology and AI companies and groups, and other stakeholders.

Develop, secure, and manage research funding. Identify and pursue opportunities for collaboration and funding, including developing and maintaining relationships with external collaborators and funders, drafting proposals, and engaging with Duke University faculty to identify related project or staffing opportunities.

Monitor and remain current in developments of significance to the portfolio and area(s) of expertise, and in the actions of key external organizations.

Develop systems for the establishment and refinement of guidelines in the collection and/or analysis of data and administration of research projects; design and evaluate alternative methodology as necessary.

Engage high-level research and writing skills to create project documents and reports and refine materials drafted by others. Ensure quality and accuracy of project deliverables which may include event-related materials, research papers, policy briefs, policy analyses, blog posts, white papers, peer-reviewed publications, and/or other high-impact knowledge products.

Seek opportunities for collaboration and cross-pollination of research and policy work across program areas within the Institute.

Serve as an articulate and effective spokesperson for Duke-Margolis. Represent Duke-Margolis and Duke University at conferences and other key meetings to present findings and foster relationships.

Interact closely with external collaborators including government officials, research and/or policy organizations, industry and health system or health care organizations, and other stakeholders to gather and disseminate information and to initiate, build and expand working relationships.

Support other key activities of the Institute on an as-needed basis, which may include teaching, student mentorship, or other work related to the educational mission of Duke-Margolis.

Portfolio Management and Development

Collaborate with Institute leadership to set, define, and reach performance goals for the program area. Identify strengths, gaps, constraints, and needs. Allocate and forecast resource utilization. Contribute to operational sustainability planning for the program area, ensuring timely tracking of project status, personnel allocation projections, and cost projections.

Develop, implement, and oversee the execution of portfolio research and administration, typically in collaboration with faculty principal investigators (PIs) for individual projects. May serve as PI when appropriate.

Work with Institute leadership, project PIs, and financial and compliance staff to create, negotiate, and monitor budgets from the proposal stage through project completion; ensure project staffing and activities are within budget projections and scope; adhere to Duke University policies; and meet contractual obligations. Demonstrate fiscal responsibility.

Consider the full breadth of implications, benefits, and risks, including financial, when evaluating varied project approaches and operational strategies.

Work collaboratively with leadership and project teams to develop and implement work plans, deliverable content, research agendas, and timelines and direct communication strategies and event management and planning. Coordinate execution of work.

Work with staff to develop, document, and implement best practices to promote knowledge management and efficiency of future projects.

Recruit, manage, and directly supervise staff, including formulating performance standards, conducting evaluations, and recommending personnel actions. Assess hiring needs in consideration of projected workload and funding.

Support project team members and direct reports to ensure their success; foster a productive team environment that encourages professional growth. Mentor junior staff (direct reports and others) in management of work activities, prioritization, and career interests.

Serve as a point of contact for current and potential sponsors to discuss potential support and partnerships. Facilitate ongoing communication with sponsors, program staff, and key stakeholders to advance projects effectively and maintain positive external and internal relationships.

Communicate effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Minimum Required Qualifications at this Level

Education/Training: Work requires analytical, communications, and organizational skills generally acquired through completion of a Master's degree in a field relevant to the specific position (e.g., health policy, public policy, public health, public administration, health economics, science, engineering, law, or field directly related to the position). Advanced degree beyond master's preferred (e.g., PhD, PharmD, MD, JD).

Experience: 10 years of progressive experience in policy/research/data analysis or other relevant position is required. Education beyond the Master's degree may substitute for years of experience on a 1:1 basis.

Or an equivalent combination of relevant education and/or experience.

Desired Skills:

• Strong organizational and interpersonal skills, high initiative, discretion, poise, and mature judgment.

• Demonstrated proficiency in policy research with strong analytical skills. Proven track record of successfully managing teams, mentoring, and developing staff.

• Direct experience in relevant FDA CDER and CBER regulatory issues.
• Proven ability to write business documents and manage project execution, including budget development and financial management.
• Excellent written and verbal communications skills; ability to communicate complex information to diverse audiences clearly and precisely.
• Ability to cultivate and maintain relationships with senior-level individuals, stakeholders, and complex organizations.
• Professional demeanor with a positive approach to working in a team environment and demonstrated proficiency in managing teams to achieve project objectives.

• Comfortable working in a fast-paced environment with varied responsibilities; able to assess the impact of and respond flexibly to changing conditions.
• Specialized experience in areas of health policy relevant to the position, including familiarity with current trends and applicable regulations.

• Record of impactful policy-relevant publications.
• Flexibility to work at alternate times (evening, early morning, weekend), if required.

• Ability to travel approximately 10%. 

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Engagements are renewable annually upon funding availability. Applications will be considered on a rolling basis.

Application Materials Required:

• Cover letter
• Curriculum Vitae
• Three References (names and email addresses)

The annual base salary range for this position is USD $115,000 to USD $195,650. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.