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Worldwide Clinical Trials este o organizație globală de cercetare clinică pe bază de contract, care sprijină companiile farmaceutice și de biotehnologie pe parcursul întregului ciclu de dezvoltare a medicamentelor. Cu o experiență de peste 30 de ani, compania oferă servicii de monitorizare clinică, gestionare a datelor, recrutare a pacienților și consultanță de reglementare în domenii terapeutice precum oncologia, cardiologia și bolile rare. Abordarea sa combină expertiza vastă în studiile clinice cu sprijin personalizat și soluții adaptate studiilor complexe.
Associate General Counsel, Clinical Research (Remote - United States)
Worldwide Clinical Trials seeks an Associate General Counsel to advise on legal risk, compliance, and sponsor contracting across its global clinical research operations. The role leads legal professionals and supports regulated business growth.
Descriere
- Counsel the General Counsel and senior leaders on complex legal, regulatory, commercial, operational, and reputational risks
- Own strategic legal subject areas and provide practical advice aligned with business goals, risk tolerance, and global operations
- Direct the drafting, negotiation, and execution of complex clinical research and sponsor agreements
- Work with Business Development, Finance, Clinical Operations, and other partners to improve contracting workflows and business performance
- Coordinate with Quality, Data Privacy, Information Security, Regulatory, and Compliance teams on GxP, privacy, data integrity, and regulatory requirements
- Contribute to enterprise risk management, investigations, compliance programs, governance initiatives, and escalation of material legal risks
- Advise on mergers, acquisitions, strategic partnerships, corporate governance, disputes, and other major business initiatives
- Manage, mentor, and develop legal team members
- Improve legal operations through process design, metrics, technology, automation, and knowledge management
Cerințe
- Juris Doctor from an accredited law school, or an equivalent qualification recognized in the relevant jurisdiction
- Current license to practice law and good standing in at least one applicable jurisdiction
- 8–12 or more years of progressively responsible legal experience
- Substantial in-house leadership experience in a CRO, pharmaceutical, biotechnology, medical device, healthcare, or similarly regulated life sciences organization
- Background supporting complex clinical research services, sponsor agreements, regulated operations, and global legal or compliance work
- Advanced commercial contracting experience covering master services agreements, statements of work, change orders, clinical research agreements, data protection agreements, and related sponsor arrangements
- Practical understanding of global clinical research regulations, GxP standards, data privacy and security duties, healthcare compliance, and research contracting
- Demonstrated ability to lead, coach, delegate, and manage change in a global matrix organization
- Sound legal judgment, commercial understanding, executive communication skills, and the ability to handle competing high-priority matters
- Fluency in English
- Proficiency with Microsoft 365, legal technology, workflow automation, analytics, and responsible AI tools
Beneficii
- Benefits package varies by work location
- Commitment to transparent compensation and pay equity
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