Legal Counsel, Clinical Development

This is a fully remote position, open to applicants in Belgium, +1 more state.

📋 Description

• Provide counsel on the legal and regulatory landscape pertinent to clinical research and development activities, including the EU Clinical Trials Regulation (ECTR), ICH GCP, and associated national requirements.

• Offer legal support to clinical operations teams throughout the setup, execution, and conclusion of clinical trials, covering feasibility, site selection, monitoring, safety reporting, and data management.

• Assist Global Patient Safety (pharmacovigilance) teams with regulatory obligations, safety reporting, signal management, and communications with competent authorities.

• Provide guidance on GxP topics (e.g., GCP, GVP, GMP, GDP, GCLP and related best practices) concerning investigational and marketed products.

• Draft, review, and negotiate a diverse array of life sciences contracts, including clinical trial agreements, agreements with CROs and vendors, pharmacovigilance contracts, quality and technical agreements, and collaboration contracts.

• Offer strategic advice on regulatory interactions with health authorities (e.g., EMA, national agencies), notified bodies, and ethics committees, including responses to inspections, audits, and regulatory inquiries.

• Contribute to the creation, implementation, and ongoing enhancement of internal policies, SOPs, and templates related to clinical research, pharmacovigilance, quality, and other GxP processes.

• Provide training and practical guidance to business stakeholders on essential regulatory and GxP legal matters.

• Keep abreast of regulatory and case law developments in the EU and other jurisdictions impacting clinical trials, pharmacovigilance, and GxP, and convert them into actionable recommendations.

⛳️ Requirements

• Fully qualified and admitted to practice in an EU jurisdiction.

• Experience in life sciences or healthcare, acquired in a pharmaceutical/biotech company, CRO, and/or a prestigious law firm.

🏝️ Benefits

• Short term incentives program

• Long term incentives program