Pharmavise Corporation ยท 1 month ago
Clinical Subject Matter Expert
United States
Contract
Remote
Senior Level
5+ years expPharmavise Corporation is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device, and Biotechnology clients. They are seeking a Clinical Subject Matter Expert to provide guidance on clinical development programs, ensuring compliance with regulatory requirements and optimizing clinical trial designs.
Food and BeverageHealth Care
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
Qualification
Required
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
Preferred
Regulatory affairs certification (RAC) or relevant professional certification (e.g., CCRA, CPI) preferred but not required
Company
Pharmavise Corporation
โฆ๐๐ฑ๐๐๐ฅ๐ฅ๐๐ง๐๐ ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒโฆ: ๐๐ก๐๐ซ๐ฆ๐๐ฏ๐ข๐ฌ๐, ๐ฒ๐จ๐ฎ๐ซ ๐ฌ๐ญ๐ซ๐๐ญ๐๐ ๐ข๐ ๐๐ข๐๐ ๐๐๐ข๐๐ง๐๐๐ฌ, ๐๐๐๐ฅ๐ญ๐ก๐๐๐ซ๐ ๐๐ง๐ ๐๐จ๐ฏ๐๐ซ๐ง๐ฆ๐๐ง๐ญ ๐ฌ๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง๐ฌ ๐ฉ๐๐ซ๐ญ๐ง๐๐ซ.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2020-04-04Seed
Leadership Team
Ricardo Joseph
Founder and CEO
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