Cambridge, Massachusetts, United States of America
Full Time
4 hours ago
$260,000 - $330,000 USD
No H1B
Key skills
Google Cloud PlatformGCPGoogle CloudLeadershipCommunicationCollaboration
About this role
Role Overview
Design cutting-edge clinical trials in collaboration with Clinical Development Leads to evaluate investigational drugs’ safety and efficacy, including protocols, patient populations, and study endpoints.
Ensure medical oversight of clinical trials, monitoring study progress, reviewing data, and managing adverse events in alignment with regulatory and ethical standards.
Lead or contribute to creating essential documents such as study protocols, Investigator’s Brochures, regulatory submissions, and safety updates.
Drive strategic alignment within Clinical Development by promoting best practices and enhancing cross-functional processes.
Provide leadership for the Clinical Science team through talent acquisition, onboarding, training, performance management, and workforce planning.
Collaborate across departments—clinical operations, biostatistics, regulatory affairs—to ensure successful execution of clinical programs.
Requirements
Bachelor’s degree in life sciences or healthcare; advanced degrees preferred.
Extensive knowledge of Good Clinical Practice (GCP) guidelines and drug development processes across Phases 1–3; expertise in oncology/immuno-oncology highly desirable.
Proven experience leading global clinical studies within pharmaceutical companies or CROs.
Advanced skills in data management systems (e.g., EDC systems) with a focus on optimizing processes for continuous improvement.
Strong ability to work effectively in matrixed environments while influencing stakeholders without direct authority.
Exceptional adaptability under tight deadlines combined with high organizational skills to prioritize tasks effectively.
Excellent verbal and written communication skills in English.