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.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED * Minimum level of education and years of relevant work experience.
- Bachelor's degree in a life science, engineering or other related discipline and a minimum of 8 years of progressively responsible and related experience in a pharmaceutical, biotechnology, CMO, CRO or related environment at least 4 years of which will have been spent in a CMC Project Management role OR an advanced degree in a life science, engineering or other related discipline AND a minimum of 6 years of progressively responsible and related experience in a pharmaceutical, biotechnology, CMO, CRO or related environment at least 4 years of which will have been spent in a CMC Project Management role.
* Special knowledge or skills needed and/or licenses or certificates required.
- Demonstrated experience planning and leading large, complex, multi-year CMC projects.
- Demonstrated experience leading cross functional teams.
- Demonstrated ability to marshal the right resources to achieve project milestones and deliverables.
- Demonstrated ability to facilitate and manage project/team meetings.
- Demonstrated ability to embrace ambiguity and complexity.
- Demonstrated ability to translate complex concepts into actionable, measurable tasks.
- Demonstrated ability to create and foster effective relationships, motivate others, influence without authority, and collaborate internally and externally at all organizational levels.
- Skilled facilitator and negotiator with a keen eye for detail and ability to successfully resolve conflicts.
- Competent with MS Project Professional or other project management tools to manage project scheduling and tracking.
- Demonstrated ability to identify and implement project management best practices within/ across project management team(s).
- Proficiency with Microsoft Office.
- Excellent verbal and written communication skills and strong presentation skills.
- High level of personal and professional integrity and trustworthiness with strong work ethic.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Ability to provide strategic input and execute on continuous improvement, productivity initiatives and out of the box approaches for rare diseases development pathways.
*Special knowledge or skills and/or licenses or certificates preferred.
- CMC project management background and understanding of the drug development life cycle.
- Prior CMO project management experience.
- In-depth knowledge of cGMP requirements for small molecules .
- Record of successful regulatory filings (INDs, IMPDs, NDAs, MAAs).
* Travel requirements 10-25% Office based position EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. Click here to return to the careers page
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PTC Therapeutics, Inc
Mar 25, 2025