Executive Director, Clinical Science Program Lead (Neuroscience)

Role Summary

Executive Director, Clinical Science Program Lead (Neuroscience) role leads the Clinical Scientist function, delivering scientific expertise to design and deliver clinical studies and programs. The position leads a team and a complex scope of work to ensure high-quality delivery of innovative protocols and data packages for CSRs and Regulatory Filings, and oversees all clinical studies within assigned program(s).

Responsibilities

• Leads a team or complex scope of work to ensure high quality delivery of innovative protocols and data packages for CSRs and Regulatory Filings
• Oversees all clinical studies within assigned program(s) to ensure consistency across program(s)
• Ensures high quality and timely delivery of protocols and data; implements quality assurance plans
• Maintains an advanced understanding of the status of all trial activities within assigned Program
• Provides scientific and clinical leadership to support the team; provide program/study/therapeutic area/skills training to team members
• Attends Development Team meetings as needed
• Leads resourcing and budget planning activities for team
• Holds accountability for the performance and professional development of Clinical Scientist team
• Leads proactive risk identification and mitigation plans; provides progress reports and risk assessment updates to Sr. Management
• Reviews and approves clinical contributions to all trial documents and abstracts
• Reviews, audits, and presents data and information to internal leaders and external investigators
• Serves as a key cross-functional collaborator; represents the Clinical Scientist function in process improvement initiatives and cross-functional activities
• Collaborates to support incoming asset and/or business development activities (i.e., due diligence)

Qualifications

• Required: 10+ years of experience in clinical science, clinical research, or equivalent; extensive experience and demonstrated proficiency in managing direct/indirect employees and leading teams

Skills

• Expertise in GCP/ICH, drug development process, study design, statistics, clinical operations
• Recognized internally and externally as a functional/technical expert
• Expert in analyzing, interpreting, and presenting data
• Advanced knowledge and skills to help lead program-specific data review, trend identification, data interpretation
• Expertise in indication, therapeutic area, compounds, competitive landscape and health authority requirements
• Ability to act independently to identify/resolve and lead the team toward resolving program-level issues
• Consistently recognized for strong critical thinking, problem solving, and decision making skills
• Advanced oral and written communication skills, including medical writing, presentations to large groups, and facilitation of interactive discussions and 1-on-1 discussions with internal and external thought leaders
• Demonstrated strong leadership presence
• Expert financial acumen
• Commitment to quality
• Adaptable / Flexible
• Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally
• Promotes a culture of scientific excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication
• Anticipates needs, assesses and manages business and organizational risks

Education

• Degree in Life Sciences (MD, PhD, PharmD, MS, RN or other scientific field preferred)

Additional Requirements

• Travel: Domestic and international travel may be required