Job Opportunity: HPM Seeks Associate Drug Development Attorney

Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add a 3rd to 6th year associate to our busy drug development team.

Our team of lawyers and regulatory experts assists clients with a wide variety of FDA regulatory issues arising in the pre-market arena for clients developing drugs and biologics.  Types of matters include:

• Informing development and providing guidance on associated regulatory strategy from early-stage (Pre-IND) activities through obtaining marketing authorization;
• Writing and advising on materials for submission to FDA during the course of product development including meeting briefing books, requests for expedited programs, INDs/NDAs/BLAs, and responses to inquiries from the Agency;
• Assisting clients with regulatory issues arising during the planning and conduct of clinical trials, including clinical trial design and IRB-related matters;
• Meeting with FDA on behalf of clients as part of FDA-sponsor meetings at stages of development and in other interactions with the Agency;
• Conducting due diligence related to transactions and securities offerings for companies with drug and biologic products; and
• Representing clients in FDA’s formal dispute resolution process, including related to clinical holds and complete response actions.

Strong verbal and writing skills are required; candidates with a scientific degree or background are preferred.

The ideal candidate will have experience working at FDA, in regulated industry, or prior big firm experience, including working with clients on pre-market drug or biologic FDA regulatory issues.

Candidates must be members of the DC Bar or eligible to waive in.

The boutique, collaborative nature of our firm provides associate attorneys unique opportunities to work directly with clients and to contribute in substantive ways to sophisticated, high-end matters.

Compensation is competitive and commensurate with experience.  HP&M is an equal opportunity employer.

Please send your curriculum vitae, transcript, and a writing sample to recruiting@hpm.com