Director, Counsel – Healthcare Regulatory and Commercial
Legal/Compliance | Waltham, MA | Full Time
Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological cancers. The company is focusing on the development of the lead product candidate melflufen, a novel peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. Melflufen is in development as a new treatment for the hematological cancer multiple myeloma and is currently being tested in multiple clinical studies including the pivotal phase 2 HORIZON study and the ongoing phase 3 OCEAN study. Oncopeptides’ US headquarters is based in Waltham, MA with an office in Mountain View, CA, and global headquarters is in Stockholm, Sweden. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.
The company is in a strong financial position and has an effective Executive Team and Board of Directors. Discover more about Oncopeptides at www.oncopeptides.com
We are currently seeking a qualified, highly motivated legal professional with pharmaceutical industry experience for the position of Director, Counsel for Healthcare Regulatory and Commercial. This position will report to Oncopeptides’ VP of Legal and Compliance and will provide compliance counsel and commercial legal support for a growing US team.
This position is based in Waltham, MA.
Key responsibilities include, but are not limited to:
· Serve as a subject matter expert in areas of healthcare regulatory law, including rules and regulations of the FDA, OIG and CMS and applicable anti-kickback, privacy, fraud and abuse, anti-bribery and product liability statutes and regulations.
· Take an active role as the legal lead for the launch and commercialization of company’s products, including participation on brand teams.
· Review and advise on promotional materials, sales training materials, and corporate communications.
· Participate as the legal representative on other commercial and medical affairs committees (e.g., Congress Planning, Investigator Sponsored Trials Review Committee) on an as-needed basis.
· Assist and advise in the conduct of internal investigations.
· Provide support for commercial contracts and other market access initiatives.
· Provide advice with respect to government pricing and reimbursement.
· Establish a strong rapport and a positive working relationship with associates at all levels, particularly within the home office and field-based Commercial and Medical Affairs organizations.
· Stay abreast of and communicate to the organization significant pending and actual decisions, legislation and regulatory rulings that may affect the company in the area of commercial healthcare law.
· Supervise external legal counsel.
· J.D. from a law school accredited by the American Bar Association (ABA).
· Admitted to practice law in one or more states.
· At least 7 years of related experience within a commercial stage pharmaceutical company or law firm equivalent.
· Large law firm experience preferred.
· Expertise in the areas of corporate compliance, commercial healthcare, and FDA regulatory law and regulation, including with respect to FDA labeling and promotional matters, healthcare fraud and abuse laws, privacy laws, anti-bribery laws, and other laws and regulations related to the development and commercialization of pharmaceutical products.