Associate Director, Clinical Science
About this role
Accountabilities:
• Lead the development of clinical study concepts, including study design, objectives, endpoints, eligibility criteria, and schedules of assessment.
• Collaborate cross-functionally to develop and refine protocols, informed consent forms, and amendments, ensuring alignment with governance and clinical development teams.
• Provide protocol training, contribute to CRF design, and ensure consistency between study documentation and execution plans.
• Engage investigators, key opinion leaders, and study sites to support study design input, feasibility, and execution readiness.
• Oversee clinical trial execution activities, including real-time data review, CRO oversight, and issue resolution.
• Develop and maintain clinical execution timelines, providing regular updates and status reporting to senior leadership.
• Partner with data management and programming teams to develop data review plans and ensure high-quality data collection aligned with protocols.
• Support clinical operations through participation in advisory boards, investigator meetings, and scientific presentations.
• Contribute to clinical research strategy, including company-sponsored and investigator-initiated studies.
• Provide scientific input into clinical trial delivery, data interpretation, and regulatory submission support.
• Ensure compliance with HIPAA, GCP, and applicable regulatory standards across all clinical activities.
• Support organizational development by contributing to process improvements and mentoring junior clinical scientists where applicable.
Requirements:
• Advanced degree in Life Sciences (MD, PhD, PharmD, MS, RN, or equivalent scientific discipline preferred).
• 8+ years of pharmaceutical or biotech experience in clinical development, with a strong focus on oncology clinical trials.
• Deep understanding of oncology, including molecular diagnostics, companion diagnostics, or early cancer detection (preferred).
• Proven experience in clinical protocol writing, data review, data cleaning, and interpretation of clinical trial results.
• Strong knowledge of FDA regulations, international regulatory frameworks, and Good Clinical Practice (GCP).
• Demonstrated ability to work effectively in cross-functional, matrixed environments.
• Experience supporting or managing direct reports, including hiring, training, and performance development.
• Strong analytical and problem-solving skills with the ability to translate complex data into clear insights.
• Excellent communication skills, including scientific writing, presentations, and stakeholder engagement.
• Ability to balance strategic thinking with detailed operational execution in a fast-paced environment.
• Strong organizational skills, adaptability, and ability to manage competing priorities effectively.
• Proficiency with Microsoft and Google productivity tools.
• Demonstrated leadership, influence, and collaboration skills across internal and external stakeholders.
Benefits:
• Competitive salary range aligned with experience and expertise
• Comprehensive health benefits including medical, dental, and vision coverage
• Fertility, parental leave, and family support programs
• 401(k) retirement savings plan and commuter benefits
• Free access to select genetic testing services for employees and families
• Flexible remote work environment (US-based)
• Paid time off and additional wellness-related benefits
• Opportunity to contribute to cutting-edge oncology and genetic diagnostics innovation
• Exposure to highly collaborative, world-class scientific and clinical teams
• Career growth opportunities in a rapidly evolving biotech environment.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
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