Director, Harvard Medical School Program in Regulatory Science

Role and Responsibilities: Harvard Medical School seeks to recruit an inaugural Director for its Program in Regulatory Science. This program is a key component of the newly established Harvard Program in Therapeutic Science (HiTS; http://hits.harvard.edu). The Director of Regulatory Sciences will hold the rank of Professor or Associate Professor at Harvard Medical School, Harvard University, or a Harvard-affiliated institution and have an established record as a leader in translational science, drug development or regulatory science. The Director will commit at least 50% effort to HiTS and is expected to remain active in research, teaching and/or clinical practice.

Programmatically, the Director of Regulatory Science will report to the Head of HiTS and work with 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 that weaves together basic, translational and clinical research related to the evaluation and approval of therapeutic drugs. The Director is expected to develop (or maintain) a research program in an area such as molecular and systems toxicology, safety science, clinical trial design, clinical pharmacology, 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 document “Advancing Regulatory Science,” we distinguish regulatory science from the strictly legal and policy components of regulatory affairs.

The Director of Regulatory Science will forge and maintain alliances involving 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 may involve creation of a pre-competitive “safe harbor” involving programs that span academe, pharmaceutical companies and regulatory agencies and tackle challenges in toxicology, clinical trial design, post-marketing evaluation, etc. The Director will work closely with HiTS faculty active in pre-clinical and translational pharmacology and toxicology including Laboratory of Systems Pharmacology (LSP) investigators developing cell and tissue-based models of drug toxicity in the heart, kidney, liver, etc. The Director will also organize educational activities for HMS graduate students, fellows and visiting scientists.

Office space, administrative support and startup funding for salary and research activities will be made available. In addition, the Director of Regulatory Science is expected to work with the Director of HiTS and other HiTS faculty to finance the program in the longer term. The 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 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 environmen Experience with, or interest in quantitative 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 the 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. He or she 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:

  • Academic 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 therapeutics development including one or more aspects of preclinical testing (efficacy/toxicity), clinical trials and post-marketing evaluation. Experience taking a 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 a demonstrated ability to build new academic programs including the ability to inspire potential 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 active in building new collaborations and contacts with FDA officials and scientists.


Applicants should send a cover letter, research statement and curriculum vitae
by August 1, 2015 to:

Laura Maliszewski
Executive Director, Harvard Program in Therapeutic Science
Armenise 137
200 Longwood Avenue
Boston MA 02115