Clinical Subject Matter Expert

Pharmavise Corporation; United States; Remote; USD 140,000 - 220,000; Full time

Benefits offered by this job

Remote work

Competitive compensation

Job summary

PharmaviseConsulting Corp. is seeking an experienced clinical development leader to guide programs from discovery through regulatory submission.

You will serve as the clinical subject matter expert, shaping trial design, patient criteria, and endpoints while ensuring alignment with GCP and ICH guidelines. You will monitor ongoing studies, evaluate safety and efficacy data, and collaborate with operations, regulatory affairs, medical affairs, and biostatistics to advance multiple therapeutic

Qualifications

• MD required with board certification or specialization preferred.
• Minimum 5 years in clinical research and development in pharma/biotech/CRO/academia.
• Deep understanding of study design, execution, and regulatory requirements (GCP, ICH E6(R2)).

Responsibilities

• Serve as the primary clinical expert guiding clinical development programs.
• Interpret protocols, designs, and development plans for scientific rigor and regulatory compliance.
• Provide strategic guidance on trial design, patient criteria, endpoints, and conduct.
• Monitor trials for safety, data integrity, and protocol adherence; identify optimization opportunities.
• Analyze clinical data and safety/efficacy outcomes to support decisions and regulatory submissions.
• Collaborate with cross-functional teams to drive clinical program execution.

Skills

Clinical trial design

Regulatory compliance

GCP knowledge

Leadership

Cross-functional collaboration

Education

MD

Board certification (preferred)

Tools

SAS

Job description

This is a remote position. From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us atwww.pharmavise.com

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.

This is a pivotal role within our organization, offering the opportunity to shape and drive clinical development programs across multiple therapeutic areas. Competitive compensation packages are available. Be part of our network of Subject Matter Experts.

PharmaviseConsulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.PharmaviseConsulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please . PharmaviseConsulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients.

When you joinPharmavise, you become part of a team that values Excellence Through Quality.

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