Our client, a leading gene therapy company headquartered in New York City, is seeking a Sr. Director of Project Management to lead, manage, and plan global operations in the execution of clinical development programs in neuroscience. The person in this role will provide regular communication to senior management of operational and development deliverables and timelines of the program.
MAJOR ACTIVITIES:
- Manage day-to-day operational and tactical aspects of multiple deliverables simultaneously, including those of high volumes of information, increased risk, and complexity.
- Planning and communication with cross-functional teams, managing project teams, producing project-specific reports, monitoring, and serving as the primary point of contact for operational issues relating to program deliverables.
- Communicate to senior management regularly regarding program deliverables.
KEY RESPONSIBILITIES:
- Lead project management activities for neuroscience clinical development programs, ensuring timelines, budgets, and deliverables are met.
- Coordinate cross-functional teams including clinical operations, regulatory affairs, medical writing, and biostatistics.
- Develop and maintain project plans, risk management strategies, and mitigation approaches.
- Ensure adherence to Good Clinical Practice (GCP), FDA/EMA regulations, and company SOPs.
- Prepare and present status reports to senior management and stakeholders.
- Drive communication between internal and external teams to ensure alignment on project goals.
QUALIFICATIONS:
- Excellent leadership, organizational, and problem-solving skills.
- Bachelor’s degree in life sciences or related field (master’s or Ph.D. preferred).
- 3+ years of project management experience in clinical development, preferably in neuroscience.
- Strong understanding of clinical trial design, execution, and regulatory requirements.
- Experience managing timelines, budgets, and resources in a clinical setting.
- Ability to work collaboratively in a global environment.
- PMP or equivalent certification is a plus.
KEY COMPETENCIES:
- Excellent oral, written, and medical communication skills required
- A detailed understanding of overall strategic direction, interrelationships and business needs
- Working knowledge of GCP/ICH guidelines and the clinical development process, understanding of drug development from pre-IND through NDA
- Extensive experience managing clinical programs, budgets, and timelines required
- Strong working knowledge of MS Project and developing Gantt charts
- Management of Contract Research Organizations, multiple vendors, and complex protocols
- Excellent interpersonal, verbal and written communication skills. Ability to effectively communicate nuances and surface the interconnections
- Problem-solving and strategic planning skills
- Self-motivated, resourceful with getting the job done attitude in a fast-paced team environment
