Senior Counsel, Life Sciences & Clinical Operations

Pharming Healthcare; Pierre (SD); Hybrid; USD 240,000 - 305,000; Full time

Benefits offered by this job

Hybrid/Remote schedule

Annual bonus

401(k) match

Healthcare benefits

PTO

Job summary

Pharming Healthcare seeks an Associate General Counsel in the United States to advise Medical Affairs, Clinical Development, Clinical Operations, and HEOR. The role reports to the U.S. General Counsel and supports biotechnology operations.

The ideal candidate has substantial life-science in-house experience, strong contracting skills, and sound judgment navigating regulatory and operational issues. Hybrid or remote with quarterly NJ travel is available.

Qualifications

• Juris Doctorate from ABA-accredited law school.
• Admission to New Jersey state bar or active license in at least one US state; ability to obtain NJ in-house license within 90 days.
• Minimum 10 years legal experience, including 5+ years in-house in life sciences.
• Familiarity with Anti-Kickback Statute, False Claims Act, FDCA; familiarity with US privacy law preferred.
• Ability to collaborate across multiple departments and travel ~10%.

Responsibilities

• Provide legal counsel on Medical Affairs strategy including scientific exchange, medical information, advisory boards, publications, and congress participation.
• Serve as primary legal advisor on clinical trial activities from startup through publication.
• Advise HEOR on evidence-generation strategies including real-world evidence and economic modeling.
• Negotiate a broad range of contracts: IISP, CTA, data transfer/use, MTAs, research collaborations, consulting and vendor agreements.
• Participate as legal representative on the Medical Review Committee; ensure materials are compliant with Medical strategy.
• Develop and maintain agreement templates, negotiation guidance, and playbooks.
• Monitor regulatory developments and flag issues affecting Pharming; advise clients accordingly.
• Partner with Compliance on policy review and training for Medical, Clinical, and HEOR teams.
• Perform other duties as assigned.

Skills

Contracting

Negotiation

Regulatory compliance

Cross-functional collaboration

Legal research

Education

Juris Doctorate (ABA-accredited)

NJ Bar admission or equivalent US license

Job description

Pharming Healthcare seeks an Associate General Counsel in the United States to advise Medical Affairs, Clinical Development, Clinical Operations, and HEOR. The role reports to the U.S. General Counsel and supports biotechnology operations.

The ideal candidate has substantial life-science in-house experience, strong contracting skills, and sound judgment navigating regulatory and operational issues. Hybrid or remote with quarterly NJ travel is available.