Kiniksa Pharmaceuticals
Senior Director, Privacy and Risk Management
Kiniksa Pharmaceuticals, Lexington, Massachusetts, United States, 02173
Reporting to the Senior Vice President, Chief Compliance Officer, the Senior Director, Privacy and Risk Management will lead Kiniksa’s global privacy program and risk management programs while serving an important role in Kiniksa’s continued enhancement of its Global Compliance program. This broad position will work to ensure compliance with all applicable privacy regulations, assist in the implementation, maintenance, and continued improvement of Kiniksa’s compliant and ethical practices and behaviors through close collaboration with internal and external business partners.
This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities
(including, but not limited to)
:
Provide day-to-day oversight and management of Kiniksa’s global privacy and risk management programs.
Maintain awareness of applicable laws and regulations and keep current with changes that may affect Kiniksa’s Compliance programs.
Partner cross-functionally with business stakeholders and IT to support the administration of system risk assessments and associated data protection impact assessments.
Develop and maintain relevant policies, procedures, and work instructions related to the capture, collection, storage and processing of data to guide the company’s operations.
Support business operations in the development and review of privacy related documents, and by providing sound advice on privacy related items.
Direct the development and execution of select trainings for new and existing employees.
Perform business risk assessments, conduct root cause analysis, risk mitigation planning and execution, and regular risk reviews to ensure effectiveness of Kiniksa’s risk management program.
Use risk assessment findings to help support the development of the company’s annual audit & monitoring plan and help inform company’s annual training plan to ensure compliance with applicable laws, regulations and company policies.
Oversee and maintain the enterprise-wide business continuity framework to ensure the program remains current, adequately addresses identified risks, meets regulatory requirements, and capability to prepare for, respond to, and recover from business disruptions.
Drive advancement of Kiniksa’s global Anti-Bribery and Anti-Corruption (ABAC) governance program including Third Party Risk Management (TPRM) to meet the changing needs of the organization.
Serve as Compliance lead on the design, oversight and execution of Kiniksa’s companywide TPRM governance program to assess, monitor and mitigate risks associated with external business partners.
Work alongside employees and company leadership to maintain and further develop a strong sense of compliance and ethics, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving.
Develop and/or identify new work processes, tools or resources that will have broad applicability throughout the organization; contribute ideas for achieving organizational goals.
Assist with internal investigations, as required, to promote a speak-up culture and compliance with all applicable laws and internal policies .
Qualifications:
10+ years of pharmaceutical compliance and/or other related experience
B.A./B.S. degree required
Advanced degree preferred (MBA or JD)
Prior designation as a Data Protection Officer (DPO) supporting European privacy operations required
Privacy professional certifications (CIPP/US, CIPP/M, CIPP/EU, etc.) a plus
Certified in Healthcare Compliance (CHC) and/or Project Management Professional (PMP) a plus.
Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including US and European privacy, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and government settlements (DPAs and CIAs).
Requires the ability to be flexible and adaptable to changes. This individual must feel comfortable in creating new processes and grow with the organizational and regulatory changes.
Excellent organization, communication, and project management skills with an ability to work in a collaborative, cross-functional environment.
Candidate must be able to work independently and prioritize multiple demands.
Strong commitment to compliance and ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel up to 15%
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities
(including, but not limited to)
:
Provide day-to-day oversight and management of Kiniksa’s global privacy and risk management programs.
Maintain awareness of applicable laws and regulations and keep current with changes that may affect Kiniksa’s Compliance programs.
Partner cross-functionally with business stakeholders and IT to support the administration of system risk assessments and associated data protection impact assessments.
Develop and maintain relevant policies, procedures, and work instructions related to the capture, collection, storage and processing of data to guide the company’s operations.
Support business operations in the development and review of privacy related documents, and by providing sound advice on privacy related items.
Direct the development and execution of select trainings for new and existing employees.
Perform business risk assessments, conduct root cause analysis, risk mitigation planning and execution, and regular risk reviews to ensure effectiveness of Kiniksa’s risk management program.
Use risk assessment findings to help support the development of the company’s annual audit & monitoring plan and help inform company’s annual training plan to ensure compliance with applicable laws, regulations and company policies.
Oversee and maintain the enterprise-wide business continuity framework to ensure the program remains current, adequately addresses identified risks, meets regulatory requirements, and capability to prepare for, respond to, and recover from business disruptions.
Drive advancement of Kiniksa’s global Anti-Bribery and Anti-Corruption (ABAC) governance program including Third Party Risk Management (TPRM) to meet the changing needs of the organization.
Serve as Compliance lead on the design, oversight and execution of Kiniksa’s companywide TPRM governance program to assess, monitor and mitigate risks associated with external business partners.
Work alongside employees and company leadership to maintain and further develop a strong sense of compliance and ethics, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving.
Develop and/or identify new work processes, tools or resources that will have broad applicability throughout the organization; contribute ideas for achieving organizational goals.
Assist with internal investigations, as required, to promote a speak-up culture and compliance with all applicable laws and internal policies .
Qualifications:
10+ years of pharmaceutical compliance and/or other related experience
B.A./B.S. degree required
Advanced degree preferred (MBA or JD)
Prior designation as a Data Protection Officer (DPO) supporting European privacy operations required
Privacy professional certifications (CIPP/US, CIPP/M, CIPP/EU, etc.) a plus
Certified in Healthcare Compliance (CHC) and/or Project Management Professional (PMP) a plus.
Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including US and European privacy, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and government settlements (DPAs and CIAs).
Requires the ability to be flexible and adaptable to changes. This individual must feel comfortable in creating new processes and grow with the organizational and regulatory changes.
Excellent organization, communication, and project management skills with an ability to work in a collaborative, cross-functional environment.
Candidate must be able to work independently and prioritize multiple demands.
Strong commitment to compliance and ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel up to 15%
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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