Executive Consultant: Clinical Development (VP/CMO)
2198 Sterling Avenue Menlo Park, CA 94025 US
We are looking to engage multiple Fractional CMOs / Executive Clinical Development Consultants to support the clinical development strategy for a stealth mode biotechnology company specialized in the Alzheimer's and rare neurodegenerative space. The company is nearing completion of a robust Phase 2 study and gearing up for Phase 3. With the Phase 2 study nearing completion, the emphasis shifts towards wrapping up the study, planning for Phase 3, refining therapeutic candidates, optimizing drug delivery, and bolstering intellectual property protection.
Location: Remote / Virtual
Engagement: Fractional PT Consultant / 1099 preferred, Part-Time Hours can vary dependent on Consultant capacity available.
Experience: Must have deep Neuro / Alzheimers (AD) expertise and experience with rare / orphan neurodegenerative a plus.
The intended scope of work can include:
Lead Completion of Phase 2 Study and Data Analysis:
- Support the final stages of the Phase 2 study, ensuring rigorous execution, comprehensive data collection, and in-depth analysis for Alzheimer's and rare neurodegenerative diseases. Provide clinical expertise in interpreting results and associated strategic / medical input for investor interactions.
Strategic Transition to Phase 3 and Regulatory Planning:
- Develop a comprehensive strategy for the transition from Phase 2 to Phase 3 clinical trials. Focus on trial design, addressing regulatory requirements, and potential liaison with regulatory authorities. Ensure clinical trial protocols meet the highest standards of medical and ethical practice.
Investor Communication and Fundraising Leadership:
- Support CEO communication with potential investors, providing strategic updates on Phase 2 progress and outlining the compelling case for Phase 3. Support presentation design and delivery, ensuring a clear and persuasive narrative.
Clinical Oversight for Therapeutic Candidate Refinement:
- Provide medical and clinical leadership in refining lead therapeutic candidates based on Phase 2 results. Offer expertise in optimizing efficacy and safety profiles for Alzheimer's and rare neurodegenerative conditions.
Advanced Clinical Trial Design and Endpoint Selection:
- Apply deep clinical knowledge to design Phase 3 trials with precision, ensuring robust methodologies, endpoints, and patient populations that align with the specificities of Alzheimer's and rare neurodegenerative diseases.
Collaborate on Drug Delivery Strategies for Phase 3:
- Work closely with the team to develop and implement advanced drug delivery technologies tailored for Phase 3 trials. Provide medical oversight to ensure precise targeting and sustained release within the central nervous system.
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