Long term full time role with the strong possibility of annual renewal if successful. Remote OK so long as willing to visit HQ as needed (Princeton NJ and Rockville MD). Detailed requirements below. Main goal is to drive assets through, interface with cross functional SMEs and stakeholders to ensure timelines are met. TA- CNS, Nephrology and possibly digital. Must be comfortable working across functions, ability to drive teams and deliverables forward in a matrix environment without direct authority over team members, can think strategically but also hands on execution.
Budget- expect to bill 1940 hours/year, maximum rate $117/hr (less experience could translate to lower rate) which translates to $225,000 annual contract value.
PSAM Program Manager
The Program Manager serves as a key driver on 2 or more development programs focused on strategic planning and oversight of operational execution. In this role, the Program Manager ensures team and Sr. Management alignment on program objectives, deliverables and timelines to support the organization’s overall goals; works with teams and management to create the development strategy, establish objectives, and monitor team progress; and makes recommendations regarding project priorities, resource requirements, and strategic considerations to established governance committees for endorsement.
Strategic:
• Provides program management for complex development programs and special projects.
• Manages established cross-functional teams and relevant functional areas to lead the development of quality Global Development & Commercialization Plans (GDCPs) which integrate the development strategy and project plan (inclusive of timelines, milestones, interdependencies, issues, risks and actions).
• Responsible for ensuring smooth transitions between stage gates of drug development from initiating IND through product launch and full life cycle management.
• Facilitates the review of development project proposals with Senior Management and ensures appropriate follow through to achieve approved program/project objectives.
• Responsible for developing a working knowledge and understanding of the science, therapeutic area and commercial landscape of assigned programs.
• Where applicable, functions as a development alliance liaison helping to support development alliance management activities based on program requirements.
• Prepares and presents program level information to Program Manager Lead for alignment; communicates accurate program information to the wider global organization through routine reports to allow strategic decision-making.
• Collaborates with data science and analytics team in delivery of projects.
• Utilize advanced analytics and data visualization tools and confirm program-level information
• Contribute to innovative/adaptive trial designs efforts and incorporate into program development planning as appropriate.
Operational:
• Supports the project teams toward implementation of the strategic and operational plans and tracks progress to goals.
• Manages and tracks program progress as assigned on a continual basis, identifying and tracking both cross-project and cross-functional risks and issues related to scope, timelines and budget. As appropriate, informs Senior management and ensures timely resolution.
• Manages project information for assigned projects and is responsible for developing and maintaining good relationships with other functions fostering positive interactions and ultimately support achieving desired project outcomes.
• Responsible for supporting departmental and corporate initiatives to drive process improvements.
• Responsible for maintenance of the project actions, decisions and risks for project team interactions.
• Partners with Finance team in driving quarterly forecasts and mid-to-long term budget planning for defined programs; reviews, challenges and ensures endorsement of projections by Senior Management.
• Identify innovative solutions (e.g. automation) to business operations and collaborate with product development teams in the creation and deployment.
Required:
• Understanding of the clinical, regulatory, and commercial requirements for early and late stage drug development
• Knowledge of clinical operations and the regulatory process.
• Knowledge of global drug development, registration, and market launch requirements.
• Thorough understanding of each functional area’s role and contribution to the development process.
• Ability to develop and drive implementation of cross-functional global drug development plans (GDDP), including strategic assessment of budgets and timelines.
• Familiarity with IT solutions integrated into the healthcare/pharmaceutical business.
• Meeting coordination and facilitation skills.
• Effective interpersonal communication in a remote/virtual environment; Communicates in an open, balanced and objective manner.
• Maintains diverse, balanced and effective teams.
• Demonstrates flexibility; approaching process changes, technology and new responsibilities with and open curious mind.
• Understands importance of potential outcomes and takes into consideration while utilizing information, sourcing and processing.
• Works creatively within predefined standards.
• Understands strategic change management and initiates application as appropriate.
• Strong analytical skills.
• Solid computer skills with MS Project, Word, Excel, PowerPoint, and Outlook.
• Excellent interpersonal, communication and negotiation skills.
• Bachelors; 5 years of Project Management experience in Pharma or Biotech.
Preferred:
• Drug / product development experience is a plus.
• Familiarity with Planisware is a plus.
• Familiarity with software development is a plus.