Director, Scientific Operations

Job Summary/Objective:

This position will oversee Scientific Operations activities and programs, including strategic annual planning, tracking metrics, educational grants and advocacy programs, educational initiatives, publications, budgets, timelines, Medical, Legal, and Regulatory (MLR) medical review management, and Investigator-Initiated Studies (IIS). The role will support launch readiness activities through cross-functional collaboration and serve as a liaison with communications on advocacy initiatives. Additionally, this position will ensure adherence to applicable processes, training requirements, and Standard Operating Procedures (SOPs), while driving continuous process improvement to promote consistency, efficiency, and compliance with all applicable laws, regulations, and guidelines.

Essential Job Functions:

• Lead cross-functional development and management of the annual strategic plan for Medical and Clinical activities, ensuring project scope, objectives, deliverables, timelines, and budgets are clearly defined and aligned with business priorities.
• Maintain and manage the budget, including tracking, analyzing, and reporting quarterly budget-to-forecast variances.
• Provide strategic guidance on Medical, Legal, and Regulatory (MLR) review processes to direct reports.
• Manage the publication vendor in the development and execution of strategic publications, including manuscripts, abstracts, oral and poster presentations, and congress publication plans.
• Oversee the strategy and execution of Medical Advisory Boards and chartered committee meetings to identify unmet medical needs and obtain feedback on proposed studies, clinical data, and scientific initiatives.
• Ensure compliance with all applicable guidelines and regulations, including Fair Market Value (FMV) requirements and Sunshine Act reporting.
• Lead the development of the annual educational needs assessment and facilitate cross-functional discussions with the Grants Committee.
• Partner closely to ensure appropriate resources are deployed to support clinical development studies.
• Ensure Scientific Affairs activities are aligned with launch team objectives and executed within established timelines.
• Represent Clinical Development and Medical Affairs (CDMA) on the Brand Leadership Team.

Competency (Knowledge, Skills, and Abilities):

• Experience supporting product launch preparation and launch readiness activities.
• CNS product experience.
• Excellent written and verbal communication skills.
• Experience with digital innovation initiatives within the biopharmaceutical industry.
• Excellent project management and organizational skills.
• Ability to work independently in a fast-paced environment.
• Proficiency in budget forecasting, management, and reconciliation.
• Ability to communicate scientific and clinical information clearly and credibly.
• Strong leadership and organizational skills, with demonstrated personnel management experience.
• Demonstrated ability to develop and drive Scientific Operations initiatives while optimizing operational processes, deliverables, and performance metrics.
• Strong strategic business acumen.
• Biopharmaceutical experience spanning clinical development operations and Medical Affairs operations.

Personal Performance Factors:

• Demonstrates strong work ethic.
• Shows initiative and holds themselves accountable.
• Lives and advances the Neurelis culture and values.
• Always operates with a high degree of integrity and tact.
• Demonstrates sound judgment and decision-making ability.

Management Responsibilities:

This position has direct reports.

• Responsibilities and skills include:
• Demonstrates ability to conduct successful meetings.
• Demonstrates good analytical skills to evaluate the business.
• Demonstrates good overall knowledge of key business and market issues.
• Demonstrates ability to hold the team to consistent and well understood standards.
• Demonstrates good teamwork at meetings and when working on projects with others.
• Demonstrates leadership with subordinates to achieve individual and collective goals.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Spends approximately 90% of work time sitting and meeting with others or working at a desk and/or computer. Spends approximately 10% of work time standing or walking within the work area or at meetings and bends, twists, stoops and reaches. Ability to communicate verbally and in writing. Occasionally lifts and/or moves up to 10 pounds. Working conditions are normal for an office environment. The noise level is usually moderate.

Travel Requirements:

• Ability to travel approximately 15% within the United States.
• Overnight travel required? Yes

Requirements

Minimum Education and Experience Required:

• Bachelor’s degree with 10+ years of relevant experience, Master’s degree with 8+ years of relevant experience, or PhD with 6+ years of relevant experience preferred.
• Demonstrated experience in Clinical Development and Medical Affairs functions within the biopharmaceutical industry required.