Michael R. Clarke, Jd, Ccep, Nacd.Dc® Email & Phone Number

United States

London, England, Gb

Senior executive providing employment law guidance and ethics & compliance assurance services to business functions at leading medical technology firm. Working with commercial and non-commercial functions as a resource for employment law counseling and guidance; risk mitigation in product promotion & field medical interactions; mitigation of third-party risks; and counseling on best practices in HCP interaction and patient engagement.

Senior executive who enhanced and expanded global specialty pharmaceutical company's corporate compliance program. Implemented and managed requirements and elements of global compliance, in partnership with commercial, medical, regulatory and finance stakeholders. Reported business ethics concerns to executive level Corporate Compliance Committee and to Nomination & Governance Committee of the Board of Directors.

Dublin, Ie

Senior member of global ethics and compliance department in global specialty and generic pharmaceutical manufacturer. Manage U.S.-based compliance staff responsible for enhancement of business ethics program in North and South America, consistent with OIG and PhRMA Code requirements, as well as in accord with anti-corruption laws and regulations.

Warsaw, Indiana, Us

Created and enhanced healthcare compliance function as a member of senior management team of spinal implant and bone growth products division of global orthopedic medical device company. Managed team of four compliance professionals implementing controls and commercial awareness of HCP/commercial interactions and consulting relationships.

Expanded prior ethics team and managed 25-person ethics & compliance department. Worked with federal monitor and Office of U.S. Attorney to enhance compliance processes consistent with federal deferred prosecution agreement. Direct reporting relationship to board of trustees and to university president.

Spokesperson for corporate compliance program, enhanced using the PhRMA guidelines, the OIG pharmaceutical manufacturer guidance and the U.S. sentencing guidelines. Created internal reporting or hotline system, assisted in creating suite of ethics & compliance policies, and developed broad ethics communications strategies, through site visit meetings that employed training sessions, focus groups and senior leadership meetings.

Philadelphia, Pa, Us

Practiced civil and criminal litigation and trial work in state and federal matters. First chair defense counsel in five jury trials and second chair for three trials in New York and New Jersey state courts, defending pharmaceutical and industrial product manufacturers, and individuals in products liability, employment discrimination, environmental litigation, professional liability and criminal litigation matters.

Responsible for defense litigation of pharmaceutical and industrial products liability, employment discrimination, environmental litigation and professional liability matters.First chair defense counsel in five trials of products liability, medical malpractice and commercial matters and second chaired three trials. Defended criminal litigation matters in state and federal courts.PRIOR RELEVANT EXPERIENCEScarinci & Hollenbeck - Secaucus, New JerseyLitigation Associate. Office of the Public Defender-Essex Adult Region - Newark, New JerseyAssistant Deputy Public Defender. Hannoch Weisman, P.C. - Roseland, New JerseyCorporate Associate.

Juris Doctor, Law

Bachelor Of Arts (A.B.), Urban Studies

Education record