Job Title: Strategic Project Leader

Level: Reporting to the CPO/CSO, Transpire Bio

Location: Weston, Florida

Summary

Reporting to the CPO/CSO, the Strategic Project Leader is responsible for driving high-impact projects that align with the company's strategic objectives. This role requires a visionary leader with exceptional project management skills, strategic thinking, and the ability to influence and guide cross-functional teams. The Strategic Project Leader will ensure projects are executed efficiently, on time, and within budget, delivering maximum value to the organization.

Essential Duties and Responsibilities

• and manage strategic projects from initiation to completion, ensuring alignment with organizational goals and strategic priorities.
• and implement comprehensive project plans, including timelines, budgets, resource allocation, and risk management strategies.
• regular project meetings, ensuring effective communication and collaboration among team members and stakeholders.
• project progress, proactively identifying and addressing issues and risks, and implementing corrective actions as necessary.
• and present detailed project updates, reports, and performance metrics to senior management, key stakeholders and external partners.
• compliance with regulatory requirements, quality standards, and company policies throughout the project lifecycle.
• a culture of innovation, continuous improvement, and excellence within the project team.
• and maintain strong relationships with internal and external stakeholders, including partners, suppliers, and regulatory bodies.
• and guide project managers and junior team members, supporting their professional growth and development.
• the adoption of best practices, frameworks, and tools for project management across the organization.
• the execution of project plans, maintains project timelines and budgets
• resources availability with responsible functional heads and ensures that all functions have resources available to achieve project goals
• and lead cross-functional program teams consisting of representatives from all functional groups
• with relevant internal stakeholders regularly on project progress, planed and proposed next steps
• with relevant external parties (Consultants, Vendors, CROs, CMOs, etc.) to ensure project activities are completed on time, on budget and with desired quality.
• external vendors providing development services, ensuring legal documents (CDA, Development and Supply Contracts) are in place and are maintained, ensuring desirable quality levels are maintained and all vendors are adequately qualified.

Qualification Requirements

• degree in life or biological sciences is required (pharmacy and graduate level degrees are preferred)
• or more years of project management experience in pharmaceutical or related fields
• knowledge of new product development; prior experience of leading the successful development of (preferably) inhalation or sterile products from early phase through process scale up to commercial manufacturing
• possess knowledge of the US and European Pharmacopoeia, cGMP, various FDA, EMA, ICH and ISO Guidance for industry, along with knowledge of the regulatory process pertaining to drug development, registration, review and approval
• to effectively manage multiple projects/submissions concurrently
• to interact effectively with internal and external personnel; strong team leader (including leading cross-functional teams)
• leadership, strategic thinking, and organizational skills.
• communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels
• analytical and problem-solving abilities, with a keen attention to detail
• to manage multiple priorities and work effectively in a fast-paced environment.