Summary

Reporting to the CPO/CSO, the Project Manager is responsible for driving high-impact innovative respiratory projects. This role requires a leader with exceptional project management skills and the ability to influence and guide cross-functional teams. The Project Manager will ensure projects are executed efficiently, on time, and within budget, delivering maximum value to the organization. The role is open to a hybrid work arrangement.

Essential Duties and Responsibilities

Lead and manage strategic projects from initiation to completion, ensuring alignment with organizational goals and strategic priorities.

Develop and implement comprehensive project plans, including timelines, budgets, resource allocation, and risk management strategies.

Facilitate regular project meetings, ensuring effective communication and collaboration among team members and stakeholders.

Monitor project progress, proactively identifying and addressing issues and risks, and implementing corrective actions as necessary.

Prepare and present detailed project updates, reports, and performance metrics to senior management, key stakeholders and external partners.

Ensure compliance with regulatory requirements, quality standards, and company policies throughout the project lifecycle.

Foster a culture of innovation, continuous improvement, and excellence within the project team.

Build and maintain strong relationships with internal and external stakeholders, including partners, suppliers, and regulatory bodies.

Mentor and guide project managers and junior team members, supporting their professional growth and development.

Drive the adoption of best practices, frameworks, and tools for project management across the organization.

Oversees the execution of project plans, maintains project timelines and budgets

Negotiate resources availability with responsible functional heads and ensures that all functions have resources available to achieve project goals

Institute and lead cross-functional program teams consisting of representatives from all functional groups

Communicates with relevant internal stakeholders regularly on project progress, planed and proposed next steps

Interface with relevant external parties (Consultants, Vendors, CROs, CMOs, etc.) to ensure project activities are completed on time, on budget and with desired quality.

Manage 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

Bachelor degree in life or biological sciences is required (pharmacy and graduate level degrees are preferred)

5 or more years of project management experience in pharmaceutical or related fields

Expert knowledge of new product development; prior experience of leading the successful development of (preferably) innovative respiratory projects from early phase through process scale up to commercial manufacturing

Must 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

Ability to effectively manage multiple projects/submissions concurrently

Ability to interact effectively with internal and external personnel; strong team leader (including leading cross-functional teams)

Exceptional leadership, strategic thinking, and organizational skills.

Excellent communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels

Strong analytical and problem-solving abilities, with a keen attention to detail

Ability to manage multiple priorities and work effectively in a fast-paced environment.