Chief Compliance Officer - South San Francisco, CA | Biospace
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Chief Compliance Officer

Rigel Pharmaceuticals, Inc.

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Location:
South San Francisco, CA
Posted Date:
9/8/2017
Position Type:
Full time
Job Code:
N17-027-51-01
Salary:
DOE
Required Education:
Masters Degree
Areas of Expertise Desired:
Administration, Compliance,

Job Description

ABOUT RIGEL:
Rigel Pharmaceuticals, Inc. is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematological disorders, cancer and rare diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's current clinical programs include clinical trials of fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in a number of indications. Rigel has submitted, and the FDA has accepted for review, an NDA for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP), for which there is a PDUFA date set for April, 2018.

POSITION SUMMARY:
Reporting to the CEO, the successful candidate will be responsible for the oversight and continued development of Rigel’s Comprehensive Compliance Program, in preparation for a potential first U.S. commercial launch in 2018.  Specific responsibilities include policy and process implementation, leading effective training programs, conducting internal monitoring and auditing, directing investigations and corrective actions as needed, and chairing/participating on various risk management committees to help ensure organizational compliance with applicable laws, regulations, industry guidance, and Company Policy.  This person will work closely and cross-functionally with executive management and operating units throughout our organization to lead and support compliance initiatives and to raise the level of awareness of compliance within our organization.


ESSENTIAL DUTIES AND RESPONSIBILITIES:
•   Responsible for the continued development, implementation and oversight of the company’s Comprehensive Compliance Program;
•   Understand and interpret the applicable laws, regulations, and related compliance landscape and provide practical, timely solutions to meet business needs;
•   Develop monitoring metrics and provide regular reporting on Rigel’s state of compliance to senior leadership;
•   Champion a corporate culture in which employees view compliance as aligned with Rigel’s core values and considered a key objective in business decisions and process development;
•   Execution and oversight of auditing and monitoring plans, including ride-alongs for customer-facing remote employees;
•   Chair Rigel’s Compliance Committee (and other such committees) and provide ongoing risk management input on business strategies and operations;
•   Manage Open-Door communication mechanisms;
•   Coordinate and manage investigations regarding matters of observed, reported or suspected non-compliance;
•   Collaborate with functional heads, as needed, toward implementing necessary corrective actions;
•   Oversee all Federal and State Sunshine reporting and related healthcare compliance requirements;
•   Serve as Company’s Privacy Officer; and
•   Represent Rigel in industry compliance forums.

Requirements

KNOWLEDGE AND SKILL REQUIREMENTS:  
Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.   
•   Advanced degree required;
•   A minimum of 8 years’ experience as a senior compliance officer in a biotech/pharma organization, to include demonstrated leadership in compliance;
•   Experience in conducting investigations and managing the entire investigative process, including the management and tracking of the investigation lifecycle and the close-out process;
•   Experience in the development, initiation, maintenance, and revision of policies and procedures for the general operation of a Compliance Program and its related activities to help detect and prevent illegal, unethical, or inappropriate conduct;
•   Should have demonstrated experience working with other compliance professionals, senior business leaders, board members, attorneys, law enforcement professionals, and regulators;
•   A solutions-oriented master collaborator;
•   Experience in hematology/oncology and/or orphan indications/rare diseases preferred, but not required;
•   Possesses strong written, verbal, and presentation skills;
•   Embrace and champion our core values; and
•   Excitement about the vision and mission of Rigel Pharmaceuticals.




Rigel Pharmaceuticals Inc. is an Equal Opportunity Employer with a commitment to diversity.
All individuals are encouraged to apply.