Program director, Research and Advocacy Fellows, & Staff Attorney

The Collaboration for Research Integrity and Transparency (CRIT) is now accepting applications for four key staff members. CRIT is a new interdisciplinary initiative, jointly led by the Yale Global Health Justice Partnership (GHJP), the Media Freedom & Information Access Clinic (MFIA), and the Center for Outcomes Research and Evaluation (CORE) at Yale-New Haven Hospital. We are seeking:

• -- A program director
• -- Two research and advocacy fellows, and
• -- A staff attorney

Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual's sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression.

The Collaboration for Research Integrity and Transparency (CRIT)

CRIT is a new collaboration that will be launched at Yale in July 2016. CRIT’s mission is to ensure that the evidence base that supports decision-making regarding pharmaceuticals and other medical products is accurate, comprehensive, and accessible. The initiative aims to strengthen the integrity of the research used to make decisions about medical products by ensuring the data are both rigorous and reliable, by promoting full access to all clinical trial information, and by supporting independent research and analysis of those data. It also will work to achieve a legal and regulatory environment that supports the production and sharing of high quality data. CRIT will undertake academic research, advocacy, and litigation to inform and shape the policy environment in this area.

For more information about CRIT and its partner organizations, see http://www.yaleghjp.org/#!crit/cgu

CRIT Program Director Opening

In collaboration with CRIT faculty leaders, the Program Director will be responsible for overseeing the implementation and development of the CRIT. S/he will, coordinate the efforts of the various team-members, manage the budget, and facilitate the collaboration’s work.

Duties include:

• -- Coordinating the efforts of the CRIT team (which includes faculty across several schools at Yale, four additional staff members, and student assistants),
• -- Directly supervising the full-time CRIT administrator
• -- Developing and managing the program budget
• -- Coordinating weekly or biweekly CRIT meetings for staff and faculty, as well as longer-range strategic planning processes at least once each year.
• -- Leading in the planning and execution of an annual symposium on research integrity and transparency at Yale, and a regular seminar series on related issues (meeting approximately five times a year).
• -- Facilitating convening of an advisory committee at least annually
• -- Working with the administrator and business office to perform financial forecasting and monthly expenditure oversight
• -- Assuring appropriate and optimal utilization of various restricted sources of funding, and leading CRIT development and grant reporting activities.
• -- Leading in the management of an internal small grants fund, which will seek applications for, and award and oversee reporting on, a series of small research grants available to faculty working on issues of relevance to the CRIT.
• -- Working with colleagues across the campus on related work on data integrity and transparency
• -- Developing relationships with outside collaborators, including other organizations working on data transparency and quality.

Applicants should have a bachelor’s degree; at least five years of work experience; a proven track record as a supervisor; proven administrative and organizational expertise; and budget-management experience. Graduate training preferred. The director will be encouraged to contribute, in addition, to the substantive work of the center, via publishing and public speaking engagements, and should have superb oral and written communications skills, interpersonal and presentation skills, and the ability to work effectively with a wide variety of constituencies.

This position starts on July 1st, 2016, or possibly sooner. Salary range: $70,000 - $87,500, depending upon qualifications, plus excellent health and retirement benefits and access to university facilities. This position is initially funded for three years and we will be applying for funding renewal. You can view University benefits at: http://www.yale.edu/hronline/benefits/index.html.

CRIT Research and Advocacy Fellows

The CRIT research and advocacy fellows will undertake original research related to the central concerns of the project and aim to publish the results in both academic and non-academic fora.   The fellows will be directly supervised by GHJP and CORE faculty and staff, with one fellow based in GHJP and one at CORE. Both fellows will be mentored by faculty drawn from Yale’s law, public health and medical schools, and will in turn help mentor Yale students interested in these topics.

The ideal candidates will have professional training in law, medicine, and/or public health; as well as experience translating academic work into policy circles. She or he will be an excellent writer and communicator and have an interest in data integrity and transparency and in drug, medical device or biologics research, development and regulation. Familiarity with the FDA and First Amendment law and prior research experience are an advantage.

The fellow will receive tailored training in research methods, and may attend relevant courses in the law, medical, and public health schools. Key duties will include:

• -- Developing publishable papers that address, for example, policy, regulatory and legal barriers to ensuring that research of pharmaceuticals and medical devices is accurate, comprehensive, and accessible; or policy or legal measures to remedy existing barriers
• -- Developing publishable papers that document, for example, reasons for and problems associated with the lack of transparency, of clinical research data; or the association clinical implications of this lack of transparency
• -- Producing policy papers and briefings, to disseminate CRIT research and shape policy and law reform recommendations in appropriate areas
• -- Facilitating CRIT’s advocacy and policy work generally, including by travelling to conferences and policymaking settings, and assisting the CRIT staff attorney with amicus briefs and other legal advocacy work

The fellow will be part of the larger CRIT staff and may assume responsibility for other shared work from time to time (e.g. organizing events and seminars).

This position starts on July 1st, 2016, and will be for one year, renewable on mutual agreement for up to three years. Salary range: $60,000 - $75,000, depending upon qualifications, plus health and retirement benefits and access to university facilities. You can view University benefits at: http://www.yale.edu/hronline/benefits/index.html 

CRIT Staff Attorney Opening

The staff attorney will be a member of both CRIT and the MFIA Clinic, with responsibility to develop and implement legal strategies that will increase transparency for clinical trials involving drugs, biologics and medical devices. At least five years of previous litigation experience is required; knowledge of FOIA, FDA drug approval policies and practices, clinical testing design and ethics, administrative procedure law, or First Amendment is preferred.

Under the supervision of MFIA director David Schulz, the staff attorney will work with CRIT faculty drawn from Yale’s law, public health and medical schools to devise and implement strategies that can achieve a significant systematic impact on access to clinical trial data, and that can shape the quality of clinical trial data produced. These strategies may include such steps as initiating litigation to enforce clinical reporting requirements, pursuing FOIA litigation, petitioning for FDA regulatory reforms, and coordinating with private and government attorneys. Activities may also include amicus work in cases of importance to CRIT issues, for example, involving First Amendment challenges to the FDA’s regulatory authority.

To implement these strategies, the staff attorney will have the assistance of Yale law students in the MFIA Clinic, and another licensed attorney who serves as a MFIA fellow. In his or her role as a supervising attorney in the Clinic, the CRIT staff attorney will play a significant role in training a new generation of lawyers to be both excellent advocates and future leaders in this area of the law. The staff attorney will supervise students on all active Clinic cases undertaken in support of CRIT’s mission, and teach a number of substantive and skill-based sessions each semester.

The staff attorney will also be able to participate in the scholarly activities of the MFIA, and its parent organization, the Information Society Project (ISP), directed by Knight Professor of Constitutional Law And the First Amendment Jack Balkin. ISP activities include regular academic lunches, workshops, conferences, and talks.

This position starts on July 1st, 2016. Salary range: $100,000 to $130,000, depending upon qualifications, plus health and retirement benefits and access to university facilities. You can view University benefits at: http://www.yale.edu/hronline/benefits/index.html

Applications

Review of applications for all positions will begin on February 15, 2016, and continue thereafter until the positions are filled. Application materials should include:

For the program director:

• -- A one to three page statement describing the applicant’s interest in the position and relevant experience;
• -- A copy of the applicant’s resume or CV;
• -- Transcripts from undergraduate and any relevant professional school; and
• -- At least one sample of recent written work;
• -- Contact information for three references, at least two of which can speak to the candidate’s professional experiences

For the GHJP research and advocacy fellow:

• -- A one to three page statement describing the applicant’s interest in the position and relevant experience;
• -- A copy of the applicant’s resume or CV;
• -- Transcripts from undergraduate and any relevant professional school; and
• -- At least one sample of recent written work;
• -- Contact information for three references

For the CORE research and advocacy fellow:

• -- A one to three page statement describing the applicant’s interest in the position and relevant experience;
• -- A copy of the applicant’s resume or CV;
• - Transcripts from undergraduate and any relevant professional school; and
• -- At least one sample of recent written work;
• -- Contact information for three references

For the staff attorney:

• -- A one to three page statement describing the applicant’s interest in the staff attorney position and relevant practice experience;
• -- A copy of the applicant’s resume;
• -- A law school (and any graduate school) transcript; and
• -- At least one sample of recent legal writing, preferably a brief or memorandum.
• -- Contact information for three references

**Please indicate clearly in the application materials the position for which you are applying **

Further information about CRIT is available at http://www.yaleghjp.org/#!crit/cgu. Contact Meredith Berger with any questions, at (203) 432-3283 or meredith.berger@yale.edu. Application materials should be sent (in electronic form) to crit.admin@yale.edu and meredith.berger@yale.edu.

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