Job Description

A leading biotech firm specializing in cardiovascular health is currently collaborating with SciPro to advance cutting-edge therapies that go beyond managing symptoms to address the underlying causes of heart disease. By harnessing a proprietary platform built on precision tools, the company develops late-stage, patient-specific treatments that target key biological drivers of cardiac conditions.

The organization recently secured a substantial round of investment to accelerate its efforts, particularly in tackling complex conditions such as cardiomyopathies that can lead to heart failure. Backed by a leadership team with deep expertise in cardiovascular therapeutics, the company is committed to reshaping treatment paradigms and pursuing potentially transformative solutions for patients.

They are actively hiring a Senior Clinical Scientist to support a pivotal late-stage clinical program. This hybrid role involves contributing to trial strategy, regulatory alignment, and cross-functional collaboration, with flexibility to work from offices located on both coasts of the U.S.

Key Responsibilities:

• Design, plan, and implement clinical trials, ensuring alignment with regulatory guidelines and scientific objectives.
• Develop and review clinical protocols, investigator brochures, and other essential trial documentation.
• Provide scientific and clinical input to trial designs, operational strategies, and data analysis plans.
• Analyze clinical trial data and work closely with biostatisticians and data management teams to ensure accurate and timely interpretation.
• Collaborate with medical writing teams to prepare clinical study reports, publications, and regulatory submission documents.
• Act as a subject matter expert for internal and external stakeholders regarding clinical trial design, strategy, and regulatory affairs.
• Ensure compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and relevant regulatory guidelines.
• Manage relationships with clinical trial sites, investigators, and vendors to ensure high-quality trial conduct.
• Contribute to the preparation and presentation of data for regulatory agencies, investor meetings, and scientific conferences.

Qualifications:

• Advanced degree (PhD, MD, or equivalent) in a scientific discipline.
• Minimum of 5 years of experience in clinical research or clinical development, with a strong understanding of clinical trial design, execution, and regulatory requirements.
• Experience in therapeutic areas relevant to the company’s portfolio is highly preferred.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
• Excellent communication, organizational, and project management skills.
• Ability to work independently and collaboratively within cross-functional teams.
• Proficiency in clinical trial management systems and data analysis tools.

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