Associate Director, Compliance
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.
ASSOCIATE DIRECTOR, COMPLIANCESUMMARY:
The Associate Director, Compliance provides direct oversight for moderate to complex elements of Pharmacyclics' compliance program, including providing compliance support and guidance to our managed access team and transparency reporting team as well as leadership and oversight for our compliance monitoring program. RESPONSIBILITIES: The Associate Director may perform the following with minimal to moderate supervision:
Actively engage with business partners to understand and provide proactive compliance guidance on proposed business strategies and programs based on compliance policies, procedures, rules and regulations; identify moderate to complex healthcare compliance issues (e.g., fraud and abuse); propose and analyze alternatives; work with legal and other functions to appropriately mitigate potential risks.
Serve as primary compliance liaison to, and support for, managed access team.
Lead coordination, management, assessment, enhancement and execution of PCYC compliance monitoring program, including oversight and trending analysis of key performance indicator metrics. Together with business partners, develop and implement corrective and preventative action plans where appropriate to address monitoring findings.
Serve as primary compliance advisor to the transparency reporting function on state and federal transparency reporting requirements. Partner with transparency reporting function to provide business leadership periodic analytics to support the annual attestation process and ensure timely, accurate, and complete aggregate spend reporting.
Assist on compliance audits such as overseeing the fulfillment of auditors' requests and acting as a liaison between the business and auditors during on-site activities. Evaluate and help respond to audit findings and recommendations, guide business partners in preparing corrective action(s), and work with business partners to ensure timely completion.
Assess, enhance and implement changes to compliance program policies, procedures and processes to meet applicable requirements and address key emerging risks. Work with internal functions to provide advice and counsel, ensure appropriate training, and support adherence to policies/procedures relating to compliance matters.
Prepare regular briefings to keep management up-to-date on latest industry events and trends including OIG and FDA enforcement statistics, CIA trends, changes to relevant industry codes, and transparency reporting requirements.
Participate in and lead moderate to complex cross-functional OEC programs.
Possess solid working knowledge of the pharmaceutical/biotechnology industry and understanding of laws and regulations applicable to pharmaceutical/biotechnology compliance.
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
Proven ability to influence individuals over whom there is not a direct reporting relationship.
Learns fast, grasps the 'essence' and can change course quickly where indicated.
Raises the bar and is never satisfied with the status quo.
Self-starter who requires little day-to-day oversight.
Possesses strong organizational skills and is able to track and oversee projects with great attention to detail.
BA/BS required. JD or MBA strongly preferred.
Minimum of 6-8 years experience in the pharmaceutical/biotechnology/medical device field (in-house, consulting, or law practice) with, or having significant exposure to, healthcare compliance (e.g., sales and marketing fraud and abuse issues, OIG and industry association guidance documents and codes, etc).