Counsel, IP and Litigation

Hikma Pharmaceuticals USA Inc.; Berkeley Heights (NJ); On-site; USD 121,000 - 221,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with Hikma match

20 days PTO

3 personal days + 11 holidays

Comprehensive benefits (health, dental

Employee discount program

Wellbeing rewards program

Tuition reimbursement

Paid maternity and parental leave

Job summary

Hikma Pharmaceuticals USA Inc. in Berkeley Heights, NJ seeks an experienced Counsel, IP and Litigation to provide strategic IP and litigation support for North American pharmaceutical injectables and non-injectables.

The role collaborates with R&D, regulatory, and commercial teams to secure patent/trademark protection and navigate regulatory approvals. The position requires extensive Hatch-Waxman and BPCIA knowledge, managing outside counsel, and advising on business development transactions,

Qualifications

• Juris Doctor (JD) from an ABA-accredited law school.
• Admission to practice law in a U.S. jurisdiction, with ability to qualify for in-house licenses.
• Bachelor's or graduate degree in a relevant scientific background.
• USPTO registration or substantial IP practice experience preferred.

Responsibilities

• Manage US patent strategies across non-injectable and injectable API selection, product development, and launch.
• Provide IP and litigation advice to R&D, regulatory, commercial, and management teams.
• Oversee outside counsel for IP and litigation matters, including settlements and strategy input.
• Manage general litigation matters, discovery, and coordination with cross-functional groups.
• Assist with regulatory strategies for new products including 505(b)(2) and ANDA.
• Perform IP and regulatory due diligence in BD and M&A deals.

Job description

Location: Berkeley Heights NJ

Job Type: Full-Time

About Us: As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

Description

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Counsel, IP and Litigation individual to join our team. In this role you will be responsiblefor providing overall strategic as well as day-to-day IP and litigation support to Hikma’s 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.

Responsibilities

• 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 Hikma’s patent and trademark portfolio.
• Implement and train on legal policies and special legal initiatives.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• 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 bachelor's 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.

Compensation

Base Salary: $121,350.00 - $220,850.00 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

What We Offer

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.