Supported company as part of two-attorney senior in-house legal team that effectively managed all legal and compliance matters during pivotal period leading up to $9.7B sale to Novartis. Reported to general counsel and partnered directly with company leadership across functions. Lead attorney for all clinical, R&D, pharmacovigilance, privacy, transparency, and clinical and general contracting matters. Data Protection Officer under EU General Data Protection Regulation. • Negotiated and oversaw legal and compliance aspects of complex and innovative collaborations with key academic and commercial development partners, resulting in study objectives being achieved significantly ahead of industry-standard timelines and below industry-standard costs. • Oversaw legal and compliance aspects of company grant and continuing medical education programs.• Integrally involved in the formation and launch of new medical affairs and commercial teams. • Post-acquisition, selected by Novartis to serve as representative on cross-functional transition team.

Lead attorney for clinical, R&D, pharmacovigilance, third-party due diligence, and privacy-related legal and compliance matters through divestment and acquisition of multiple assets and advancement of clinical program for company’s key asset, inclisiran. Legal representative on various senior-level committees that reviewed clinical protocols, safety signals, and potential distribution partners and managed post-approval research grants. Developed, and subsequently managed, procedures and processes for reviewing research grant requests.

Lead attorney for all contracting, clinical, R&D, and pharmacovigilance-related legal and compliance matters through regulatory submission and launch of multiple products. Decreased contracting and clinical study start-up time, increased visibility and compliance, and improved audit and inspection performance through oversight of global contracting, including development, launch, and management of custom Contract Lifecycle Management (CLM) system, contract templates, contracting playbooks, and policies and procedures governing contracting by or on behalf of company.

Represented and advised corporate clients in complex litigation matters as senior associate in top-ranked product liability and mass tort practice group. Developed litigation strategies; conducted research and drafted key motions, briefs, and memoranda; took and defended depositions; managed selection and preparation of experts; prepared company witnesses for depositions and governmental investigations; conducted client interviews of key employees, including Board of Directors of Fortune 500 company, and oversaw collection of documents from same; negotiated with plaintiffs’ counsel regarding discovery issues; evaluated pharmaceutical clients’ sales and marketing policies and promotional materials for compliance with government regulations and industry codes. Managed and mentored teams of attorneys and paralegals. Provided pro bono legal counsel in various areas, including obtaining a life-saving grant of deferral of removal under the Convention Against Torture for a Jamaican citizen in a proceeding before a U.S. immigration court

Focused on complex pharmaceutical product liability litigation. Managed large caseload from discovery through trial preparation; took depositions; managed local counsel in various states; prepared defense strategies; conducted medical and legal research; drafted motions, briefs, and pleadings; negotiated dismissals and removal of cases to later discovery groups; and supervised record collection by paralegals, local counsel, and outside vendors. Defended national contractor in employment and construction contract litigation. Represented national bank in foreclosure actions involving New York properties.

Represented pharmaceutical companies, product manufacturers, physicians, and other corporate clients in all phases of mass tort, product liability, medical malpractice, and a variety of other types of litigation. Advised clients regarding FDA regulations, federal and state anti-kickback regulations, and state licensure and Medicaid requirements for nonresident pharmacies and providers of durable medical equipment. Researched and drafted memoranda of law and client report letters for corporate, health care and litigation departments.