Associate General Counsel - US

Pharming Group N.V.

10d•$240,000 - $310,000•Hybrid

About The Position

The Associate General Counsel will serve as the primary legal advisor for U.S. Medical Affairs, Clinical Development, Clinical Operations, and Healthcare Economics and Outcomes Research (HEOR). The position reports to the U.S. General Counsel. The ideal candidate has substantial experience supporting biotechnology or pharmaceutical companies, strong contracting skills, and sound judgment in complex scientific, regulatory, and operational matters. The role may be based in the Warren, New Jersey office with a hybrid schedule, or be fully remote. Remote candidates must be willing to travel to the New Jersey office quarterly, in addition to normal business travel for conferences or internal meetings. Domestic and international travel is approximately 10% of the time. Pharming is a global biotechnology company focused on developing and commercializing therapies for rare and ultra-rare immunological and genetic diseases. Its work is guided by patients, caregivers, clinicians, scientists, and partners, with an emphasis on collaboration, urgency, ownership, and advancing rare disease care. The base salary range is $240,000–$310,000 per year. Pharming is a merit-based equal opportunity employer.

Requirements

Juris Doctor degree from an ABA-accredited law school.
Admission to the New Jersey state bar and in good standing, or an active license to practice law in at least one U.S. state, with the ability to secure a limited in-house license from the State of New Jersey within 90 days.
Minimum of 10 years of legal experience, including at least 5 years of prior in-house experience within the life science industry.
Familiarity with the federal Anti-Kickback Statute, False Claims Act, and Food, Drug and Cosmetic Act.
Ability to work constructively and collaboratively across multiple departments.
Strong interpersonal and communication skills.
Strong data management and software skills.
Ability to travel domestically and internationally approximately 10% of the time.
Commitment and alignment with Pharming’s mission, core values, and behaviors.

Nice To Haves

Familiarity with U.S. privacy laws preferred.

Responsibilities

Provide legal counsel on Medical Affairs strategy and activities, including scientific exchange, medical information, advisory boards, congress participation, publications, and engagement with healthcare professionals.
Serve as the primary legal advisor on clinical trial activities, from study planning and startup through conduct, closeout, and publication.
Advise the HEOR team on evidence-generation strategies and activities, including real-world evidence studies, observational research, patient-reported outcomes research, economic modeling, and comparative effectiveness research.
Advise on and negotiate contracts, including investigator-initiated study agreements, clinical trial agreements, data transfer and data use agreements, material transfer agreements, research collaboration agreements, consulting agreements, and vendor agreements.
Participate as the legal representative on the Medical Review Committee (MRC), ensuring medical materials are legally compliant and aligned with Pharming’s Medical strategy.
Drive process improvements, including developing and maintaining agreement templates, negotiation guidance, and playbooks.
Monitor legal and regulatory developments, identify issues that could affect Pharming, and advise clients accordingly.
Partner with Compliance on policy review and training initiatives for Medical, Clinical, and HEOR teams.
Perform other duties as assigned.