Director, Clinical Development – MD

Provide clinical oversight and medical monitoring for one or more clinical trials in neurology and/or autoimmune disease
Contribute to the design and implementation of clinical studies, including early-phase and proof-of-concept trials
Draft and/or review protocols, protocol amendments, investigator brochures, clinical study reports, informed consent forms, safety narratives, and other clinical trial documents
Participate in investigator meetings, site engagement activities, and selected site initiation activities
Support execution of clinical development plans by identifying study risks, proposing mitigations, and tracking milestones, deliverables, and budget-conscious study decisions
Interpret research, translational, and nonclinical findings and translate them into clinical development opportunities
Interact with investigators, key opinion leaders, and external experts
Partner with Regulatory Affairs, Safety, Clinical Operations, Biometrics, Translational Sciences, Medical Writing, and other functions
Provide clinical input to regulatory submissions and responses to health authority questions for INDs and clinical trial applications
Contribute clinical guidance in interactions with advisory boards, patient advocacy organizations, and internal stakeholders
Present scientific or clinical data at investigator meetings and scientific congresses and contribute to abstracts, presentations, and publications
Support due diligence or clinical evaluation of external opportunities as needed

Requirements

• MD or DO required
• Approximately 2 to 5 years of clinical, scientific, and/or drug development experience in biopharma, academia, healthcare, or related settings
• Working knowledge of clinical trial design, protocol development, safety review, and Good Clinical Practice
• Ability to function effectively in a matrixed, cross-functional team environment
• Board certified or board eligible in Neurology
• Training and clinical expertise in neurology, neuroimmunology, or autoimmune neurologic disease
• Drug development experience in neurology, autoimmune disease, cell therapy, immunology, or other advanced therapeutics
• Experience supporting Phase 1, Phase 1b/2, or proof-of-concept studies
• Demonstrated ability to contribute to study design, study conduct, and emerging data interpretation
• Strong clinical judgment, scientific rigor, and problem-solving skills
• Effective written and verbal communication skills
• Ability to work with appropriate independence while escalating issues thoughtfully
• Ability to build productive working relationships with internal colleagues, investigators, and key thought leaders
• Comfort operating in a fast-paced and evolving development environment
• May travel up to 25%

Core Competencies

Demonstrates expertise in clinical trial design, protocol development, and regulatory submissions, with a strong focus on neurology and autoimmune diseases. Proven ability to collaborate effectively in cross-functional teams while maintaining scientific rigor and clinical judgment.

Highest-signal resume keywords

• MD Or DO
• Clinical Trial Design
• Good Clinical Practice
• Board Certified In Neurology
• Drug Development Experience In Neurology

ATS Optimization Keywords

Hard Skills

• Protocol Development
• Safety Review
• Clinical Study Reports
• Informed Consent Forms
• Phase 1 Studies
• Proof-Of-Concept Studies
• Data Interpretation
• Clinical Oversight
• Medical Monitoring
• Risk Mitigation

Soft Skills

• Effective Communication
• Problem-Solving
• Relationship Building
• Independence
• Scientific Rigor

Certifications & Qualifications

• Board Certified In Neurology

Industry Keywords

• Biopharma
• Neuroimmunology
• Autoimmune Disease
• Clinical Development Plans
• Translational Sciences
• Clinical Operations
• Regulatory Affairs
• Investigator Meetings
• Patient Advocacy Organizations
• Health Authority Submissions