ED / VP, Clinical Development (50% Part-Time)
681 Gateway Blvd., Suite 411 South San Francisco, CA 94080 US
Our client is seeking an accomplished and visionary VP Clinical Development/Chief Medical Officer (CMO) to lead their Neurology pipeline on a part-time basis (~20 hours per week). The successful candidate will provide strategic medical and clinical leadership, drive the development of novel therapies in the field of neurology, and oversee the successful execution of clinical programs. This is an exceptional opportunity for an experienced medical professional with a strong background in neurology and a passion for advancing therapeutic solutions.
Medical Strategy and Leadership:
- Define and execute the medical and clinical strategy for the Neurology pipeline (Dementia focus), aligning it with the company's overall objectives and vision.
- Provide leadership, guidance, and mentorship, fostering a culture of innovation, collaboration, and scientific rigor.
- Collaborate closely with cross-functional teams, including Research and Development, and Regulatory Affairs, to drive the successful development of neurology (Dementia) therapies.
- Lead the design, planning, and execution of clinical programs, ensuring compliance with regulatory requirements and industry standards.
- Oversee clinical trials, including site selection, patient recruitment, protocol development, and data analysis, to generate robust clinical evidence supporting the safety and efficacy of neurology (Dementia) therapies.
- Develop strong relationships with key opinion leaders, academic institutions, and clinical investigators to leverage external expertise and advance clinical development efforts.
- Awareness of relevant regulations, guidelines, and best practices in neurology drug development and ensure adherence to regulatory requirements throughout clinical programs.
- Collaborate with Regulatory Affairs to prepare and submit high-quality regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and marketing authorization applications.
Scientific and Medical Expertise:
- Strong familiarity with the latest advancements in neurology research, emerging treatment modalities, and therapeutic trends.
- Serve as a medical and scientific expert, internally and externally, representing the company at conferences, scientific meetings, advisory boards, and other relevant forums.
Collaboration and Communication:
- Foster collaborative relationships with internal stakeholders, external partners, and key opinion leaders to drive scientific exchange, gain insights, and build strategic alliances.
- Effectively communicate clinical development plans, study results, and other medical information to internal teams, executives, and external stakeholders.
- Medical Doctor (M.D.) degree with specialization in Neurology, ideally Dementia. Board certification is highly desirable.
- Significant experience in clinical drug development, preferably in the start-up biotechnology space, with a mandatory focus on neurology.
- Proven leadership experience in a medical or clinical role, including leading cross-functional teams and managing clinical programs.
- Strong understanding of regulatory requirements and experience with regulatory interactions in neurology drug development.
- Excellent knowledge of clinical trial design, execution, and data analysis.
- Outstanding communication and presentation skills, with the ability to effectively convey complex medical and scientific information to both technical and non-technical audiences.
- Demonstrated ability to think strategically, make critical decisions, and drive results in a fast-paced, dynamic environment.
- Strong network and relationships within the neurology and dementia medical community.
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