Overview In this role you will provide strategic and day-to-day IP and litigation support for Hikma's North American pharma injectables and non-injectables business. You'll collaborate with R&D, regulatory, and commercial teams to secure patent and trademark protection, navigate Hatch-Waxman and BPCIA processes, and manage outside counsel on IP and litigation matters. You'll advise on settlements, due diligence for BD deals, and contribute to IP portfolio strategy for launches and acquisitions. The role combines legal leadership with cross-functional influence to protect products and enable growth.
Responsibilities- Develop US patent strategies across API selection, product selection, and pipeline development through launch
- Provide IP and legal guidance on Hatch-Waxman timing for product approvals and launches
- Oversee outside counsel and patent litigation, coordinating discovery and expert retention, and shaping litigation strategy
- Advise management on litigation strategy, launch scenarios, and settlements; negotiate settlements
- Manage all aspects of general litigation with outside counsel (contracts, products liability, employment) from discovery to appeal
- Guide other departments on risk and approach to potential or ongoing litigation
- Contribute to regulatory strategies for 505(b)(2) and ANDA products; assist in IP and regulatory due diligence for BD deals and M&A
- Identify opportunities for patent and trademark protection with R&D and commercial teams; coordinate portfolio management
- Implement and train on legal policies and initiatives
Key requirements- Juris Doctor (JD) with bar admission in a U.S. jurisdiction; ability to qualify for in-house licenses
- Bachelor's or graduate degree in a relevant scientific field
- License to practice before USPTO or substantial IP practice experience, preferably Hatch-Waxman and BPCIA
- 7+ years of experience; in house experience desirable; experience with global pharma or life sciences clients preferred
- Excellent analytic, drafting, and oral communication skills; ability to lead and meet demanding deadlines
- Ability to manage multitasking in a cross functional, multicultural environment; travel up to 10-15%
- strong communication and drafting abilities
- leadership and cross-functional collaboration
- deadline-driven and organized; multitasking
- USPTO registration (preferred)
- Hatch-Waxman Act and BPCIA knowledge
- IP portfolio management and due diligence for M&A