Alzheimer’s Disease Regulatory Science Fellowship
Posted 16 Apr 2014
Food and Drug Administration
Silver Spring, Maryland, U.S.A.
Applications should be made to http://www.reaganudall.org/our-work/building-scientific-capacity/alzheim..., and should include:
- a CV;
- a personal statement (~500 words) describing your background, interest in this fellowship, and how the fellowship fits into the applicant's long-term goals;
- two writing samples;
- medical/osteopathic school transcript.
Applications will be reviewed on a rolling basis with a flexible start date between July and November of 2014.. For questions, contact firstname.lastname@example.org
The two-year fellowship will be awarded to an experienced physician to work within the FDA’s Division of Neurology Products (DNP) to identify opportunities for collaboration with patient groups, academic researchers, and pharmaceutical manufacturers to advance the development of treatments for Alzheimer’s and other dementias. Activities will include:
- developing a comprehensive understanding of the regulatory review process;
- learning current challenges facing Alzheimer’s drug development and regulation;
- developing an awareness of DNP practices, thinking, and approach to various aspects of AD drug development, data, and other scientific resources (e.g. trial design, therapeutic targets);
- seveloping a comprehensive summary of the current landscape of AD drug-development activities, including all relevant consortia, initiatives, and other stakeholder activities;
- facilitating and maintaining dialogue among the FDA and stakeholders with regard to activities in AD drug development;
- determining areas of mutual interest and identifying mutually beneficial initiatives between DNP stakeholder groups;
- creating a strategy and implementation plan for DNP’s participation in public-private partnerships, initiatives, and other activities with AD stakeholders.
- training in regulatory science, clinical trial design/conduct, statistical analysis, and drug/ biologics law;
- attending educational briefings, scientific rounds, and other relevant seminars;
- presenting the FDA perspective on selected topics related to AD.
Applicants should have a strong commitment to improving the health of individuals with AD. The ideal candidate should also possess:
- a medical degree (M.D., D.O.);
- several years of clinical experience working with patients with AD and/or other dementias;
- a basic understanding of the design and conduct of clinical trials;
- knowledge of the AD research landscape;
- the ability to write and communicate clearly as well as thoughtfully summarize and convey complex information to varied audiences;
- experience with academic presentation and publication;
- high degree of comfort level working independently and collaboratively;
- experience with multi-stakeholder partnerships or relationship building between diverse stakeholders.