Director Clinical Operations Full Time NEW

We’re partnering with a growing pharma company advancing a clinical-stage pipeline. They are seeking a Clinical Director to provide medical and scientific leadership across their portfolio of programs.

Key Responsibilities

• Lead the design and execution of clinical development plans across Phase I–III studies
• Provide medical oversight and strategic input into clinical trial design, endpoints, and patient populations
• Contribute to overall program strategy and decision-making at the leadership level
• Oversee clinical trials to ensure scientific integrity, patient safety, and operational excellence
• Review and interpret clinical data to inform ongoing development decisions
• Partner with Clinical Operations to ensure timelines, budgets, and deliverables are met
• Serve as Medical Monitor for clinical studies (as needed)
• Review safety data, adverse events, and support safety signal detection
• Collaborate with Pharmacovigilance on safety strategy and reporting
• Provide clinical input into regulatory submissions and health authority interactions
• Support development of key documents (protocols, IBs, CSRs, briefing packages)
• Represent the company at investigator meetings, advisory boards, and conferences
• Lead data review meetings and contribute to interpretation of clinical results
• Present clinical data internally and externally to stakeholders
• Provide clinical risk assessment and competitive landscape insights

Required Qualifications

• MD (or equivalent medical degree) required
• 8–12+ years of clinical development experience in biotech/pharma
• Experience in clinical trial design and execution (Phase I–III)
• Prior experience serving as Medical Monitor
• Strong understanding of GCP and clinical regulatory requirements
• Experience working cross-functionally in a drug development environment
• Ability to interpret clinical data and translate into strategic decisions
• Strong communication and stakeholder management skills

Preferred Qualifications

• Board certification or clinical practice experience in a relevant therapeutic area (oncology, CNS, rare disease)
• Experience leading clinical programs in a mid-sized or growing biotech environment
• Direct interaction with regulatory agencies (FDA, EMA)
• Experience contributing to regulatory submissions (INDs, NDAs, BLAs)
• Track record of advancing programs through key clinical milestones
• Prior involvement in KOL engagement and external scientific communication
• Experience supporting business development or due diligence activities