Director, Harvard-MIT Center for Regulatory Science

Role and Responsibilities: Harvard Medical School seeks to recruit a Director for the Harvard-MIT Center for Regulatory Science (HMCRS). The Center was launched in June 2018 as one of the two research divisions of the Harvard Program in Therapeutic Science (HiTS; http://hits.harvard.edu). HMCRS seeks to advance the basic, translational and clinical science used to evaluate therapeutic drugs and devices in human clinical trials and the impact of new science on regulatory practice and policy. The Center Director will lead research, education and outreach activities for the Center. Eligible candidates will have an existing appointment at the rank of Professor, Associate or Assistant Professor at Harvard Medical School, Harvard University, or a Harvard-affiliated institution. She or he will have an established record as a leader in translational biomedicine, drug development, regulatory science or a related discipline. The Center Director will commit 50% effort to HiTS (this effort does not impact assignable effort on sponsored research grants) and is expected to remain active in research, teaching and/or clinical practice. The initial term of the appointment is five years with the expectation of renewal.

Programmatically, the Center Director will report to the Head of HiTS (Peter Sorger) and work with the HiTS faculty and advisory committees, as well as the leadership of Harvard Medical School and its affiliated Hospitals, to develop and implement a plan for regulatory sciences across multiple institutions including MIT. The Center Director is expected to maintain (or develop) a research program in an area such as clinical trial design, clinical pharmacology, molecular and systems toxicology, safety science, post-marketing drug evaluation, pharmaco-genomics, pharmaco-economics or the economic, legal, policy, ethical, and social aspects of drug regulation. As described in FDA’s guidance “Advancing Regulatory Science,” we distinguish regulatory science from the strictly legal and policy components of regulatory affairs.

The Center Director will forge and maintain alliances among partner institutions such as Harvard-affiliated hospitals and other medical schools, other schools at Harvard University and in the Boston area, regulatory agencies such as the FDA and EMA and pharmaceutical and biotech companies. This is expected to involve creation of a pre-competitive “safe harbor” spanning academe, pharmaceutical companies and regulatory agencies.

The Center Director will oversee the HMCRS fellowship program comprising up to 12 scholars of all ranks involved in regulatory science and organize educational activities for HMS and MIT graduate students, fellows and visiting scientists. He or she may also work closely with HiTS faculty active in the Laboratory of Systems Pharmacology (LSP; the second research division in HiTS) who are developing cell and tissue-based models of therapeutic and adverse drug response. The Center Director will also be involved in philanthropic fundraising and securing sponsored research funding.

Office space, administrative support and startup funding for salary and research activities will be provided. In addition, the Center Director is expected to work with the Director of HiTS and other HiTS faculty to finance the program in the longer term. The Center Director will also serve as principal investigator on industry and government-sponsored research awards in support of his/her research.

The Candidate: Eligible individuals will hold an M.D., Ph.D. or M.D./Ph.D. degree and a current full-time or part-time Harvard appointment at the Assistant Professor, Associate Professor or Professor level at any School at Harvard University or the HMS clinical affiliates. The candidate will have a record of academic excellence as a principal investigator and success in funding her/his research. Practical experience in industry, clinical medicine or a government agency is a plus. The candidate will demonstrate understanding of the organization of research-focused academic enterprises and will have a record of leadership in a dynamic academic/medical/industry environment. Experience with, or interest in quantitative and systems approaches to biomedicine, including data science, bioinformatics, systems biology, and biostatistics, is a definite plus.

The successful candidate will be an individual who thrives in a complex academic environment and has the capacity to understand human and organizational dynamics and a proven ability to build bridges between colleagues in academic, clinical, and industry settings. Functioning in a relationship-driven culture where intellectual leadership is valued, the successful candidate will exhibit a combination of insight, innovation, transparency, fairness, persuasiveness, and commitment to the institution. She or he will have the ability to bring ideas to the table in a way that they can be understood, and promote those ideas across the broader University.

Critical competencies for this position include two or more of the following:

  • Leadership in Regulatory Science or Translational Biomedical Research. The successful candidate will have experience in and be seen as a potential leader in regulatory science and the clinical evaluation of therapeutics, commanding the respect of both clinical and research faculty. The ability to function as a principal investigator and establish a grant-based research portfolio is essential.
  • Clinical Leadership in Therapeutics Development. The successful candidate will have experience with development of therapeutic drugs including one or more aspects of preclinical testing (efficacy/toxicity), clinical trials or post-marketing evaluation. Experience taking a device or drug through clinical trials and/or working with the FDA is a plus.
  • Institutional Leadership in Creating and Sustaining New Research Programs. The successful candidate will have the ability to build new academic programs including the ability to inspire faculty collaborators, rally and connect with partners in the pharmaceutical industry, and build a functioning community committed to advancing the scientific foundations of drug development and evaluation. It is essential that the Director be committed to building new collaborations and contacts with FDA officials and scientists.

 

Applicants should send a cover letter, research statement and Harvard curriculum vitae
by October 20, 2018 to:

Laura Maliszewski
laura_maliszewski@hms.harvard.edu
Executive Director
Harvard Program in Therapeutic Science
Armenise 137A
200 Longwood Avenue
Boston MA 02115