Contract, Clinical Scientist

Key Responsibilities

• Support and enhance Medical Monitor oversight for clinical trials, ensuring appropriate delegation and execution of medical monitoring activities.
• Aid Clinical Development Leads in implementing development plans for novel drug candidates within cross-functional clinical trial teams.
• Collaborate with Clinical Operations, Data Management, and Biometrics to develop study tools, data outputs, and study plans.
• Review clinical trial documents with Clinical Development Leads, incorporating therapeutic direction and patient selection strategies as appropriate.
• Oversee clinical trial conduct to ensure compliance with GCP, patient eligibility requirements, and protocol adherence.
• Lead medical data review, cleaning, analysis, interpretation, and communication for ongoing and completed studies.
• Support safety data review and ensure timely identification and resolution of safety issues as assigned.
• Contribute to the development and review of regulatory documents and communications, including INDs, IBs, annual reports, CSRs, abstracts, manuscripts, and presentations.

Requirements

• Holds a graduate degree and is passionate about advancing innovative therapeutics in the neuromuscular disease space.
• Minimum of 3–5 years of industry experience in drug development.
• Medical monitoring experience required.
• Direct patient care experience preferred.

Skills

• Strong understanding of the regulatory environment, including experience responding to Health Authority requests and timelines.
• Demonstrated proficiency in medical data review, cleaning, analysis, interpretation, and communication.
• Experience with genetic therapeutics preferred.
• Additional experience in non-DMD therapeutic areas (e.g., Immunology) is a plus.
• Ability to manage high-priority activities independently while engaging senior leadership appropriately.
• Working knowledge of GVP, FDA, and EMA regulations and guidelines.
• Excellent interpersonal and communication skills.
• Proficiency in PowerPoint, Excel, and Microsoft Office.
• Willingness to travel as needed.

Benefits

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.