Drug Development Project Manager

Proclinical is currently recruiting for a Drug Development Project Manager with a global pharmaceutical company located in Boston, MA. As the Project Manager, you will be responsible for development, management and tracking of the integrated program timeline, which includes the clinical supply execution plan and incorporates the deliverables across Global Operations, Quality, Reg Aff/Reg Aff-CMC and Process/Product Development.

Job Responsibilities:

• Facilitates and documents cross-functional team meetings to ensure on time delivery of product supply and key program regulatory CMC milestones.
• Enables clinical supply execution and operational excellence by implementing program management tools (timelines, minutes, agendas, risk management, etc) and practices to ensure delivery of supply and regulatory filings.
• Drives execution of the program to achieve goals/objectives without compromising program deliverables or quality.
• Proactively manages the program critical path, assesses operational feasibility of strategic plans, and identifies and manages program risk.
• Manages the program schedule, budget, and resource information to enable efficient and effective CMC portfolio management.
• Responsible for development and management of the communication plan and stakeholder management plans.
• Manage a team with a diverse array of talents and responsibilities. Work closely with cross-functional teams to plan and develop scope, deliverables, required resources, work plan, budget, and timing for programs.
• Implement and manage changes to ensure program goals are achieved.

Skills and Requirements:

• Bachelors' degree in business or scientific discipline required. Advanced degree and/or PMP Certification preferred.
• Excellent knowledge of program management discipline and its application to drug development.
• 5-7 years of related experience in biopharmaceutical industry.
• Demonstrated success in leading and negotiating in a matrix-based organization.
• Demonstrated ability to identify key program risks and develop mitigation strategies and contingency plans.
• Strong track record in program management in cross-functional drug development teams and/or clinical, regulatory, pharmaceutical sciences/technical operations team(s) in the biopharmaceutical industry.
• Demonstrated ability to facilitate program team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
• Proficiency in core Microsoft software products (e.g., Excel, Word, PowerPoint, and Project). Experience with MS Project online preferred.

If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 312-291-4181.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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