Clinical Subject Matter Expert

Job Summary


Responsibilities

• Serve as the primary clinical expert within the organization, providing guidance and support across clinical development programs.
• Review and interpret clinical trial protocols, study designs, and clinical development plans to ensure scientific rigor and compliance with regulatory requirements.
• Provide strategic input and guidance on clinical trial design, including patient selection criteria, endpoints, and study conduct.
• Monitor ongoing clinical trials for protocol adherence, patient safety, and data integrity, and identify opportunities for optimization and risk mitigation.
• Analyze and interpret clinical trial data, including safety and efficacy outcomes, and provide insights to support decision-making and regulatory submissions.
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, medical affairs, and biostatistics, to drive successful execution of clinical programs.
• Stay abreast of emerging scientific advancements, clinical trial methodologies, and regulatory requirements in the field of clinical research.
• Represent the organization externally as a clinical expert, including participation in scientific conferences, regulatory meetings, and interactions with key opinion leaders.

Qualifications

• Advanced degree in medicine (MD) or equivalent; board certification or specialization in a relevant therapeutic area preferred.
• Minimum of 5 years of experience in clinical research and development within the pharmaceutical or biotechnology industry, CRO, or academic research setting.
• In-depth understanding of clinical trial design, execution, and regulatory requirements, including GCP guidelines and ICH E6(R2).
• Proven track record of successful clinical trial management and oversight, including experience with Phase I-IV trials.
• Strong analytical and problem-solving skills, with the ability to critically evaluate clinical data and scientific literature.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.
• Leadership experience and the ability to influence and inspire cross-functional teams to achieve common objectives.
• Regulatory affairs certification (RAC) or relevant professional certification (e.g., CCRA, CPI) preferred but not required.

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