What are the responsibilities and job description for the Clinical Subject Matter Expert position at Pharmavise Corporation?
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 at www.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.
EEO Employer:
Pharmavise Consulting 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. Pharmavise Consulting 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 contact info@pharmavise.com.
Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.
