Experience

Ithaca College

• Advisory Board Member - Ithaca College - Cybersecurity Program

  • Oct 2022 - Present



Novartis Pharmaceuticals, USA

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Lead Compliance Policy & Functional Advising Center of Excellence

  • Mar 2015 - Present

  Neuroscience, Cardiovascular, Ophthalmology, Immunology, Dermatology & RespiratoryEthics Risk & ComplianceHealthcare ComplianceClinical Development Medical AffairsHealth Care System Access & Engagement C-suite levelMedical/Commercial CollaborationResearch Collaboration Implementation ScienceGrant, Sponsorship & other funding Clinical Trials Interactions with healthcare professionals & government officialsCode of ConductAnti-BriberyStark Law & FCAConflict Of InterestAudit, Monitoring & InvestigationEnterprise Risk Assessment & ManagementManagement Experience

• Head Integrity & Compliance, Americas

  • Mar 2013 - Mar 2015

  Ethics & ComplianceHealthcare ComplianceP3 Promotional PracticesInteractions with health Care ProfessionalsCode of ConductAnti-Bribery• Built a strong integrity & compliance programs with a team of local compliance officers• Collaborated and developed an outstanding working relationship with the business, Internal Audit & Speak-up Office in reviewing & addressing a wide range of regional & country specific issues• Conducted a review of the business compliance policy: proposed & implemented enhancements to the policy• Established a strong compliance network with Pharma Centers of Excellence. This resulted in Pharma supporting OTC Americas in the Fair Market Value process, Sunshine act initiative and other key OTC priorities• Collaborated with regional leadership/GMs and their respective functions (QA, Tech ops, R&D, HR etc..) to coordinate all the compliance initiatives and training across the Americas regions.• Collaborated with each country (OU GM, local compliance officer and local leadership team) to Identify the country top 5 risks and aligned on the appropriate mitigation & monitoring steps• Enhanced the visibility of the Compliance function & conducted frequent market visit, onboarding the country OU GM and the local country leadership,• Performed a resource need and a skill set need assessments in each country. Recommended to upgrade the skill set of certain local compliance officers and worked with the country GM to identify the right talent to drive change.• Successfully supported and passed all internal audits in the Americas region (Colombia , Venezuela, Canada, & Global I&C audits)

• Director, Clinical Operations

  • Jan 2007 - Feb 2013

  CLINICAL THERAPEUTIC AREA EXPERIENCE:• Pain: acute & chronic indications in: knee & hip replacement, dental pain, knee & hand OA. Phase 1 to 3. Multiple formulations: IV, oral, gel & iontophoretic patch• Diabetes: metformin & glyburide in Phase 1 & 2. HbA1c devices, oral & foot care with OTC products.• G.I.: day & night time heartburn Phase 3 studies for a PPI Rx to OTC switch.• Immunology: biologic agent in renal transplant indication• C.V.: fenofibrate & statins in different phases and in a Rx to OTC switch• H.R.T.: estrogen & progesterone patches in Phase 1 & 2• Pediatric studies: PK studies in Cough & Cold• Rx to OTC Switches: statin & heartburn programs: with Phase 3, label comp & actual use studies• Size of the programs: from <100 subjects to 2,000 subjects with cost from $1MM to $40 MM

• Associate Director, Clinical Operations

  • Mar 2004 - Dec 2006



Rutgers University

• New Jersey

• Adjunct Assistant Professor

  • Feb 2013 - Nov 2022
  • New Jersey

  Teach a 3-credit Clinical Operations course (Master in Clinical Trial Sciences)



University of Medicine and Dentistry, New Jersey

• NJ

• Adjunct Assistant Professor

  • 2011 - Jun 2011
  • NJ

  Teach a 3-credit Clinical Operations course (Master in Clinical Trial Sciences)



Bristol-Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Clinical Manager

  • Mar 2003 - Feb 2004

• Clinical Manager

  • Apr 2002 - Mar 2003



Bristol-Myers Squibb

• Sr CRA

  • 2000 - 2002



UPSA Bristol-Myers Squibb

• Sr CRA

  • 1998 - 2000

  UPSA - Bristol-Myers Squibb in Paris France



Laboratoire Fournier

• CRA

  • 1996 - 1998

  Laboratoire Fournier in Dijon, France