Clinical Development Lead: Strategy & Study Oversight

Supernus Pharmaceuticals Inc; Rockville (MD); Hybrid; USD 164.000 - 190.000; Vollzeit

Zusammenfassung

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

You will serve as clinical lead for assigned studies, shape development plans, oversee CROs, ensure ICH-GCP compliance, and partner across Clinical Operations, Regulatory, Biostatistics, and Medical Affairs to translate data into actionable development decisions.

Qualifikationen

• M.D. preferred with 6+ years in Clinical Development, Clinical Science, or Medical Affairs.
• PharmD or PhD in scientific discipline or equivalent with min 5+ years in Clinical Development, Clinical Science or Medical Affairs.
• Typically, 5-8+ years of experience in Clinical Development, Clinical Science, Medical Affairs, or related drug development functions.
• Experience with protocol development, medical monitoring, clinical data review, CSR authorship, and CRO oversight.
• Working knowledge of FDA, EMA, and ICH-GCP requirements; strong clinical judgement.

Aufgaben

• Contribute to CDPs for marketed and pipeline products.
• Lead the design, authoring, review, and implementation of clinical protocols and amendments.
• Develop and communicate study-level benefit-risk assessments and contribute to program-level evaluations.
• Evaluate safety data, protocol deviations, eligibility assessments, and study conduct.
• Partner with Clinical Operations on feasibility, enrollment, and site engagement strategies.
• Oversee CROs, vendors, and consultants supporting assigned studies.
• Ensure compliance with protocol requirements, ICH-GCP, and applicable regulations.
• Translate clinical findings into actionable development recommendations for leadership.

Kenntnisse

Clinical development leadership

Protocol development

Medical monitoring

CSR authorship

CRO oversight

Safety data review

Executive communication

Cross-functional leadership

Strategic thinking

Leadership without authority

Ausbildung

M.D.

PharmD

PhD

Jobbeschreibung

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

You will serve as clinical lead for assigned studies, shape development plans, oversee CROs, ensure ICH-GCP compliance, and partner across Clinical Operations, Regulatory, Biostatistics, and Medical Affairs to translate data into actionable development decisions.