The IP & Litigation Counsel provides overall strategic as well as day-to-day IP and litigation support to Hikmas North American pharmaceutical injectables and non-injectable business. This position will work closely with the research & development team with product selection, product development and design, obtaining patent and trademark protection or clearance, regulatory approval, and launch. This position will also provide general IP and litigation counselling and will manage outside law firms in connection with IP and litigation matters and will negotiate settlements of disputes where appropriate. This position will additionally provide substantive guidance, diligence, and input on business development transactions and acquisitions. It is expected that the person will have a significant experience with the pharmaceutical industry and have deep understanding of the overall regulatory framework under which a generic manufacturer generates ANDA, 505(b)(2), aBLA filings, including the Hatch Waxman Act and the BPCIA.
- Ability to juggle multiple matters in an organized manner without losing track of any of them. Dependable and timely work product.
- Manage the development of US patent strategies during noninjectable and injectables API selection, product selection, and pipeline development through launch. Work with R&D scientists, regulatory, commercial, and management teams to provide quick and accurate IP and other legal advice on all aspects of the Hatch-Waxman Act, including the timing of product approvals and launches.
- Oversee outside counsel and patent litigation including coordinating discovery, expert retention, and providing substantive input on legal strategies and settlement negotiations. Provide advice to management on litigation strategy, launch scenarios, and settlements. Negotiate settlements.
- Manage outside counsel in all areas of general litigation including commercial contracts, products liability, employment, and other matters, from discovery through trial and appeal. Manage discovery, document collection, and related matters; provide substantive input on legal strategies and settlements and succinctly advise management regarding the same. Provide input and assistance to other departments and counsel on the proper approach to matters involving potential litigation or the risk of litigation.
- Assist with developing regulatory strategies for new products including 505(b)(2) and ANDA products.
- Work with business development teams to conduct IP and regulatory due diligence. Provide IP and legal advice on business development deals, including licensing, co-development, marketing, and product acquisitions. Review and edit BD contracts with a practical awareness of both legal and business risks. Assist with IP and regulatory due diligence on M&A deals.
- Work with R&D and commercial teams to identify new opportunities for patent and trademark protection. Assist in the development, management, and coordination of Hikmas patent and trademark portfolio.
- Implement and train on legal policies and special legal initiatives.
- A Juris Doctor (JD) degree from an ABA accredited law school, admission to practice law in a U.S. jurisdiction with the ability to qualify for additional in-house licenses as needed.
- Strong academic credentials, including a bachelors or graduate level degree in a relevant scientific background; a license to practice before the USPTO or substantial intellectual property practice experience, preferably in Hatch-Waxman and BPCIA litigation; extensive knowledge of the Hatch-Waxman Act, the BPCIA, and related regulations and practices.
- Minimum: More than 7 years experience which should include experience with a top law firm, preferably representing global pharmaceutical and/or life science clients. Prior in-house experience with a global pharmaceutical or other life science company is desirable.
- Preferred: More than 10 years experience.
- Preferred: USPTO registration or the ability to be qualified for such registration.
- Excellent analytic, legal drafting and oral and written communication skills and ability to lead a must.
- Ability to work efficiently, to prioritize workflow, to meet demanding deadlines, to work with cross-functional groups in a multicultural environment, and to manage multi-dimensional projects in a fast-paced environment.
- Up to 10% -15% travel is required.
- The candidate must be capable of building strong, lasting and effective business relationships, and cultivating and maintaining the position of trusted advisor to stakeholders within Hikma.
Notification to Agencies
Please note that Hikma does not accept unsolicited resumes or calls from third-party recruiters or employment agencies. In the absence of a signed Master Service Agreement and approval from HR to submit resumes for a specific requisition, Hikma will not consider or approve payment to any third-parties for hires made.
To apply for this job please visit www.goinhouse.com.