Strategic Clinical Development Lead

Supernus Pharmaceuticals; Rockville (MD); On-site; USD 164,000 - 190,000; Full time

Job summary

Supernus Pharmaceuticals in Rockville, MD is seeking an Associate Director, Clinical Development to lead the design, execution, monitoring, interpretation, and communication of clinical research for marketed and investigational products.

The role includes study-level clinical leadership, safety review, and collaboration with Clinical Operations, Regulatory, Biostatistics, Pharmacovigilance, and Medical Affairs to advance development programs and strategic decisions.

Qualifications

• MD preferred with 6+ years in clinical development, clinical science, or medical affairs.
• PharmD or PhD with 5+ years in related functions.
• 5-8+ years in clinical development, clinical science, medical affairs.
• Experience with protocol development, medical monitoring, CSR authorship, and CRO oversight.
• Working knowledge of FDA, EMA, and ICH-GCP requirements.

Responsibilities

• Lead the design, execution, monitoring, and interpretation of clinical studies.
• Serve as study-level clinical lead for assigned trials and provide strategic input.
• Oversee CROs, vendors, and external collaborators to ensure compliant execution.
• Partner with Regulatory, Biostatistics, Pharmacovigilance, Medical Affairs and Clinical Operations.
• Translate complex data into actionable development recommendations for leadership.

Skills

Clinical development

Regulatory knowledge

Leadership

Education

MD, Preferred

PharmD or PhD in scientific discipline

Job description

Supernus Pharmaceuticals in Rockville, MD is seeking an Associate Director, Clinical Development to lead the design, execution, monitoring, interpretation, and communication of clinical research for marketed and investigational products.

The role includes study-level clinical leadership, safety review, and collaboration with Clinical Operations, Regulatory, Biostatistics, Pharmacovigilance, and Medical Affairs to advance development programs and strategic decisions.