Associate Director, Compliance
Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, an oral, first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company is also exploring development candidates in its novel G9a inhibitor program. By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them. For more information, visit www.epizyme.com.
Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies. Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.
Reporting to the Chief Compliance Officer, the Associate Director will support the design, implementation, and enhancement of Epizyme’s compliance program and its compliance operations. The Associate Director will work closely with business colleagues on the Commercial, Medical Affairs, Finance, Human Resources, and Legal teams to sustain Epizyme’s strong ethical culture and ensure adherence to the Company’s Code of Conduct and related rules, policies, and procedures. The Associate Director will also focus on effective compliance operations with a specific focus on areas including transparency reporting, managing engagements with heath care providers, and training.
We are seeking an experienced compliance professional with 7+ years of relevant pharmaceutical industry experience. This position reports directly to the Chief Compliance Officer, and is based in Cambridge, MA.
- Partner with employees and leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving
- Ensure client operations comply with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations, antitrust, and FDA requirements;
- Support the implementation and maintenance of US federal and state transparency reporting requirements and assist business leadership in meeting reporting obligations
- Ensure that interactions with health care professionals and patients comply with applicable legal requirements and company policies
- Analyze advisory board proposals, speaker programs, and medical education initiatives for fraud and abuse, FDA, and other regulatory compliance
- Support the implementation of a robust privacy program and help pull through privacy requirements
- Prepare and deliver training and education to ensure understanding of employee responsibilities and ethics and compliance issues, as well as related policies and procedures
- Execute routine and risk based monitoring and auditing of relevant business activities and related policies and procedures; identify potential areas of compliance vulnerability and risk; assist in and oversee the implementation of corrective action plans as necessary; and generate reports on monitoring, auditing and risk assessment
- Travel required
- Other responsibilities as may be assigned from time to time in the company’s discretion
Education & Requirements:
Candidates for the position should have the following: JD preferred, 5-7 years of experience working within the pharmaceutical industry, experience with counseling business leaders, and a strong understanding of the operational requirements for a compliance program in the pharmaceutical industry.
The successful candidate will possess the following attributes:
- Minimum of 5-7 years of ethics, compliance and/or legal experience in a Commercial stage organization subject to US biopharmaceutical, medical device or other relevant healthcare compliance laws and regulations
- Experience in biotech, healthcare or medical device industries is preferred
- Experience developing, implementing, and monitoring a compliance program
- Experience with metrics used to measure success of the compliance program
- Demonstrated experience identifying and resolving compliance issues
- Demonstrated ability to work collaboratively and cross-functionally in a team environment with a wide variety of company personnel on a broad range of matters
- Ability to manage multiple tasks simultaneously and to flourish in a fast-paced and high energy environment
- Able and eager to work independently and to manage and oversee discrete areas of responsibility with little direct supervision
- Excellent organization, communication and prioritization skills, including the ability to communicate concisely, to integrate legal and business considerations, and to provide balanced advice regarding risks
- Experience with transparency reporting and privacy a plus
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.