Posted:
Job Description
Job Title: Clinical Operations Lead
Location: 100% REMOTE
Client Business Driver
Our client is a small, emerging biopharmaceutical company that has acquired a small molecule asset administered via IV for the treatment of sickle cell disease.
Following Health Canada approval of their CTA submission, the organization is preparing to initiate its Phase 3 clinical program and requires an experienced Clinical Operations Lead to guide study startup and execution.
The Work
- The Clinical Operations Lead will oversee and manage all operational aspects of the Phase 3 program, ensuring timelines, quality, and compliance are maintained.
- Responsibilities include, but are not limited to: Providing strategic and operational leadership through study startup and execution.
- Managing external CRO and vendor relationships, ensuring clear communication, accountability, and adherence to timelines and deliverables.
- Overseeing site selection, feasibility, and activation activities across participating regions.
- Partnering closely with cross-functional teams (Regulatory, CMC, Data Management, and Safety) to ensure program readiness and alignment.
- Supporting the development and review of study plans, protocols, monitoring tools, and essential documents.
- Overseeing clinical supply management, including labeling, storage, and distribution to trial sites.
- Making recommendations regarding potential bridging studies or protocol adaptations as needed.
Hard Skills:
- BSc (advanced degree such as MSc or PhD preferred) in a relevant scientific discipline.
- Proven success in a similar role within a small or emerging pharmaceutical company, ideally with hands-on experience in Phase 3 study startup and execution.
- Demonstrated expertise in clinical operations oversight, including vendor/CRO management and operational risk assessment.
- Strong understanding of GCP, ICH, and regional regulatory requirements.
Soft Skills:
- Enthusiasm for working within a small, fast-paced organization with lean infrastructure.
- Highly proactive, organized, and communicative, with a collaborative and solution-oriented mindset.
- Skilled at managing and influencing partners and CROs diplomatically to ensure proper oversight and accountability.
- Excellent written and verbal communication skills, with the ability to translate complex information across functional lines.
- Comfortable working independently on multiple competing priorities in a dynamic and evolving environment.