Director, US Compliance Lead
- Waltham, MA
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
The Director, US Compliance is a high-profile position providing leadership and direction for the development and implementation of Oncopeptides’ US Healthcare Compliance Program. This position will report to Oncopeptides’ VP of Legal and Compliance and will require regular interactions with the company’s Compliance Committee and US commercial leadership.
This position is based in Waltham, MA.
Key responsibilities include, but are not limited to:
· Lead the continued development and implementation of the US Healthcare Compliance Program, including policies, procedures, and training related to the company’s US operations.
· Partner closely with other departments, including US commercial and medical affairs leadership, providing day-to-day input and business advice related to compliance questions and continuing to grow our culture of compliance.
· Assist with the development of annual risk assessments, taking into account the external environment and company- and product-specific risks.
· Provide oversight of the US auditing, monitoring and analytics plan and help execute on designated aspects of the plan.
· Identify and implement metrics and key performance indicators that measure the effectiveness of the US compliance program.
· Conduct internal compliance investigations as necessary, either individually or working with the legal team.
· Answer Healthcare Compliance questions and promptly respond to concerns or suspected violations.
· Remain up-to-date on industry-related best practices and enforcement activities and update the compliance committee and other Oncopeptides associates, as appropriate.
· 7+ years of industry-related experience, including a minimum of 5 years in-house healthcare compliance experience within a U.S. biotech or pharmaceutical company.
· Bachelor's Degree required. J.D. or Master's degree in related areas (such as compliance, business) desirable.
· Expertise in the areas of corporate compliance, including state and federal laws and regulations, industry guidelines and other requirements relevant to the Company's compliance program, including fraud and abuse and anti-kickback laws, OIG and PhRMA guidelines, FDA regulations and guidance on promotion, state and federal aggregate spend reporting requirements, and corporate integrity agreements.
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