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Clinical Strategy:
Develop and implement clinical development strategies for assigned programs, including go/no-go decisions, adaptive trial designs, and patient enrichment strategies.
Conduct competitive intelligence analyses to identify opportunities and challenges within the competitive landscape.
Contribute to the development of regulatory strategies and interactions with health authorities.
Project Management:
Oversee the day-to-day activities of clinical trial operations, including site selection, investigator training, and data monitoring.
Track project timelines and budgets, ensuring timely completion of milestones.
Identify and mitigate potential risks and challenges.
Communication & Collaboration:
Effectively communicate clinical development plans and progress to internal and external stakeholders, including senior management, investors, and scientific advisors.
Build and maintain strong relationships with key opinion leaders (KOLs) in the neurology field.
Clinical Development Consultant - Neurology
- Posted 24 January 2025
- LocationBoston
- Job type Contract
- Reference210122
- Contact NameChloe Cummins
Job description
Clinical Development Consultant, MD - Neurology
Location: San Francisco, CA
Our client is a pioneering biotechnology company dedicated to developing innovative therapies for neurodegenerative diseases.
The CEO is seeking a highly motivated and experienced Clinical Development Consultant (MD) to play a critical role in the advancement of the organization's promising neurology pipeline. The Consultant will provide strategic guidance and hands-on expertise in the design and execution of clinical trials for novel therapies. This is an exciting opportunity to contribute to groundbreaking research and make a significant impact on the lives of patients with neurological disorders.
Key Responsibilities:
- Protocol Development:
- Lead the development and refinement of clinical protocols for Phase 1-3 clinical trials, ensuring alignment with regulatory requirements (e.g., FDA, EMA) and best practices in clinical research.
- Develop study objectives, endpoints, and statistical analysis plans.
- Collaborate with cross-functional teams (e.g., medical, scientific, regulatory, biostatistics) to ensure protocol feasibility and alignment with overall development strategy.
Qualifications:
- Proven experience in the design and execution of Phase 1-3 clinical trials, including protocol development, data analysis, and regulatory submissions.
- Expertise in neurology therapeutic areas (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis) is highly preferred.
