Head of Clinical Recruitment ┃ Biotech & Pharma Talent Leader
Overview
Our client is a commercial-stage biopharmaceutical organization dedicated to developing and delivering innovative therapies for patients with rare and underserved conditions. With a global footprint and a strong focus on late-stage development through commercialization, they are advancing a portfolio of therapies across genetic, orphan, and neurological diseases.
Position Summary
The Director of Clinical Operations will play a critical leadership role in driving the planning, execution, and oversight of clinical programs from late-stage development (Phase 2/3) through post-approval (Phase 4). This individual will be accountable for ensuring the successful delivery of studies—whether internally managed or executed via CROs and other external partners—while maintaining the highest standards of regulatory compliance and operational excellence.
Responsibilities
- Provide operational leadership across all aspects of clinical trials including study planning, site selection, initiation, enrollment, monitoring, and study close-out.
- Manage program budgets, timelines, and resourcing; oversee forecasting, accruals, and vendor invoicing.
- Translate product and development objectives into actionable operational strategies in collaboration with cross-functional stakeholders.
- Lead vendor and site oversight, ensuring performance against key milestones; negotiate contracts and budgets with external partners.
- Ensure adherence to GCP, ICH, FDA, and global regulatory requirements; proactively identify risks and implement mitigation plans.
- Partner cross-functionally with data management, biostatistics, pharmacovigilance, regulatory, medical writing, and quality teams to drive execution.
- Oversee development and review of study documentation including protocols, informed consents, and operational manuals.
- Contribute to clinical program strategy, feasibility assessments, inspection readiness, and audit support.
- Support preparation of clinical reports, investigator brochures, and publications.
Qualifications
- Advanced degree preferred (PharmD or Master’s in a scientific/health-related field).
- 8–10+ years of progressive clinical operations experience within the biopharma industry.
- Proven track record leading late-stage and post-approval trials, both internally and via CRO/vendor partnerships.
- Strong knowledge of GCP, ICH, FDA, and global clinical research regulations.
- Excellent project management, leadership, and communication skills.
- Ability to manage multiple priorities in a fast-paced, matrixed environment.
- Proficiency with clinical trial management systems and related tools.
Job Details
- Seniority level: Director
- Employment type: Full-time
- Job function: Research