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Associate Director Clinical Research
2 months ago
Job Title: Freelance Associate Director of Clinical Science (Early Phase Neurology)
Location: Remote, with occasional travel as required
Position Type: Freelance/Contract
Overview:
We are an innovative early-phase biotechnology company focused on advancing breakthrough therapies in neurology. Our mission is to develop and deliver transformative treatments for patients with unmet neurological needs. We are seeking an experienced Freelance Associate Director of Clinical Science to provide critical expertise in the design, execution, and analysis of our early-phase clinical trials. This is a unique opportunity to play a pivotal role in a dynamic biotech environment, contributing to the development of first-in-class therapies for neurodegenerative diseases and other central nervous system (CNS) disorders.
Key Responsibilities:
- Clinical Strategy and Protocol Development: Work closely with the Director of Clinical Science and cross-functional teams (including Clinical Operations, Regulatory, Biostatistics, and Medical Affairs) to design and develop protocols, clinical development plans, and strategies that support the progression of early-stage neurology programs.
- Scientific and Clinical Input: Provide expert input on scientific and clinical aspects of study design, patient eligibility, endpoints, safety monitoring, and risk mitigation in early-phase clinical trials.
- Study Execution and Oversight: Collaborate with Clinical Operations to oversee study conduct, ensuring adherence to timelines, budgets, and regulatory requirements. Provide clinical and scientific oversight of investigational sites to ensure data quality and consistency.
- Data Review and Analysis: Participate in data review and interpretation, contributing to the development of study reports and regulatory submissions. Provide scientific insights to guide decision-making regarding dose escalation, cohort expansion, and other study-related adaptations.
- Cross-Functional Collaboration: Partner with key internal and external stakeholders, including KOLs, CROs, and investigators, to foster alignment on study objectives and scientific strategy.
- Regulatory and Compliance Support: Support regulatory submissions, including IND applications, briefing documents, and responses to agency inquiries. Ensure studies are conducted in compliance with regulatory guidelines and ethical standards.
- Communication and Reporting: Develop and deliver clear, accurate updates and scientific presentations to leadership, the clinical team, and relevant stakeholders on study progress, challenges, and key findings.
Required Qualifications:
- Education: Advanced degree in life sciences (PhD, MD, or PharmD preferred).
- Experience: Minimum of 5 years of experience in clinical science or clinical research in the biotech or pharmaceutical industry, with a strong background in neurology or CNS disorders.
- Technical Skills: Solid understanding of clinical trial design and methodology, particularly in early-phase trials. Familiarity with FDA, EMA, and other regulatory requirements.
- Analytical Skills: Experience with clinical data review, interpretation, and statistical analysis. Strong ability to assess and communicate complex scientific data.
- Communication: Excellent verbal and written communication skills, with the ability to clearly convey scientific and technical information to both specialized and general audiences.
- Adaptability: Strong ability to work independently in a fast-paced, dynamic environment, managing multiple projects and priorities. Must be comfortable in a virtual, matrixed team structure.
- Problem-Solving: Solution-oriented approach with a proactive, hands-on attitude toward overcoming challenges and ensuring study success.
Preferred Qualifications:
- Neurology Focus: Prior experience in early-phase development for neurodegenerative diseases or other CNS disorders is highly desirable.
- Project Management: Experience in project management and leading cross-functional teams.
- Publication and Presentation: Proven track record of scientific publications and/or presentations in neurology or CNS-related fields.
What We Offer:
- Competitive hourly or project-based compensation
- Flexibility in work hours and remote work options
- Opportunity to work with a pioneering team in the neurology biotech space
- Engagement in meaningful projects with potential for long-term impact on patient care
Application Instructions: To apply, please submit your resume, a brief cover letter detailing your relevant experience, and references.
