Director - Planning, Strategy & Project Management

Job Description Summary:

The Director - Planning, Strategy and Project Management (PSPM) co-leads and facilitates multiple Chemistry Manufacturing and Controls (CMC) development-stage project teams. This includes, but may not be limited to, leading, coordinating, prioritizing and assisting in all aspects of cross-functional CMC projects and ensuring each project is scoped, defined, and executed in a consistent and timely manner; collaborating with internal, cross-functional teams and externally with the Project Managers at PTC’s Contract Manufacturing Organizations (CMOs) to develop comprehensive project timelines, risk management plans and mitigation strategies; and working closely with Project and Development Program Management to ensure the integration of CMC-related cross-functional activities into the broader, development project plan(s) to advance PTC assets through development and global marketing authorization.

He/She actively participates in the integration of the CMC strategy with the program strategy and monitors/reports on status and progress, highlighting risks and mitigation plans, to ensure full transparency to key internal/external stakeholders.

He/She works closely with the head of the Pharmaceutical Development (PD) organization and the PD leadership team (PDLT) to co-lead strategic planning meetings as well as periodic PD staff meetings and PDLT strategy meetings. He/She contributes to the definition and execution of short- and long-term CMC strategic objectives and associated action plans designed to deliver increases in productivity, cost effectiveness, etc.

This position collaborates closely with PD/TechOps, QA, RA management, Finance business partners and HR business partners to build and nurture cross-functional relationships that lead to successful clinical and registrational submissions in a timely and cost-conscious manner. The incumbent is also responsible for identifying, evaluating, and implementing process improvements by using best practices appropriate for a biotech focused on rare diseases.
He/She ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Co-leads and facilitates CMC project team meetings to ensure all CMC team deliverables and activities are aligned across other functions. Facilitates communication to ensure clarity and transparency.

• Functions as the primary point of contact for project teams on the status of all CMC-related issues, both on-going and potential, as appropriate.  She/He may also be responsible for functioning as the project team’s interface with senior and executive management.

• Develops and manages integrated CMC timelines across programs to ensure that the CMC timelines and dependencies align with the overall master project plan.

• Works closely and communicates effectively with cross-functional teams and CMOs to ensure the CMC Project Team is set up to successfully deliver on all CMC project commitments.
  • Coordinates and leads project team meetings, Issues meeting minutes and manages action items.
  • Proactively defines potential risks and risk management strategies.
  • Identifies project objectives and scope.
  • Builds a fully integrated CMC timeline.
  • Develops and implements stakeholder management and communication plans.

• Identifies, evaluates, and implements opportunities for continuous process improvements within the Pharmaceutical Development and other cross-functional teams.

• Shares opportunities/best practices with his/her project management peers and across project management teams.

• Works collaboratively with PDLT to design short-term and long-term strategies and tactics for rapid yet cost efficient development.

• Works cross-functionally with Quality and Regulatory teams to build cross-functional relationships and to augment compliance aspects related to GMP and inspection readiness.

• Engages stakeholders with a solution-oriented focus and presents strategies and plans to senior management and governance forums, as required.

• Fosters a culture of ownership and accountability including continuous evaluation, recognition, and process improvement.

• Works closely with PDLT and Finance Business Partners to create and manage PD budget.
• Collaborates with PDLT and HR Business Partners to maintain a high-performance PD team, and foster team building and engagement.

• May manage, coach and mentor direct reports if required.

• Performs other tasks and assignments as needed and specified by management.