Director/Sr. Director, Project Management at Pionyr Immunotherapeutics
South San Francisco, CA, US
Pionyr Immunotherapeutics Inc. is a well-funded and growing South San Francisco-based clinical stage immuno-oncology company focused on novel approaches to cancer immunotherapy. We are looking for an experienced project management leader to partner with project teams to execute our plans for multiple clinical and preclinical Development projects.
Responsibilities include, but not limited to:
- Develop and successfully execute multiple written project plans and integrated timelines in collaboration with Research project team members.
- Collaboratively partner with cross functional team members from key functional areas including Research, Regulatory, Manufacturing, Quality, Clinical and Finance to develop and execute integrated product development plans.
- Maintain functional alignment of plans with project stakeholders; track key project activities and actions, timelines, milestones and costs to meet project goals.
- Manage all aspects of the PT mtgs, including scheduling, agendas, facilitation, and minutes for PT meetings ensuring regular, efficient team and stakeholder communication
- In partnership with Business Operations team, facilitate contract changes, issue resolution, contract clarifications for assigned research outsourcing engagements
- Synthesize numerous sources of data and key analysis translating into specific actions to support company strategy.
- Ensure adequacy of project resources with research team and Department Heads.
- Anticipate, identify, communicate, and propose resolution options for discrepancies in priorities, plans, and activities for immediate resolution.
- Establish and monitor team member responsibilities, if applicable.
- Develop and implement processes to provide or create information to enable informed decision making within teams.
- Manage competing timelines and prioritize critical tasks.
- Track project status and effectively communicate it to project team members and senior management through distribution of minutes, PT dashboards, and document archiving as appropriate
- Proactively identify and manage key long-term project issues.
- Effectively work with Finance, project team representatives and department managers to develop project budgets and monitor spending against plan.
- Lead the development of standards for project and process management
- Facilitate resolution of issues pertaining to project priorities and team dynamics.
- This position requires a Bachelor’s degree in the Life Sciences. An advanced degree is a plus with at least 10 years of successful experience developing pharmaceutical or biotechnology drugs including 5-7 years’ experience in cross-functional project team management; experience within oncology and/or immuno-oncology preferred. PMP certification is a plus
- An in-depth understanding of the pharmaceutical development process, from early stage therapeutic development through IND approval process
- Familiarity with FDA Center for Drug Evaluation and Research (CBER) protocols and guidelines as well as overall understanding and knowledge of IND application filing process.
- Solid understanding of functional area roles, and responsibilities, product development activities and interdependencies, project planning experience a must.
- Proven ability to independently integrate and manage multiple projects and/or sub-team plans simultaneously.
- Proficiency in Microsoft Project, and basic Office software, e.g. word-processing, power point, and spreadsheet software, required.
- Ability to positively influence others towards the best interest of company and product goals while keeping the attainment of project milestones on track.
- Ability to adapt to a changing work environment.
- Effective record keeping and presentation skills (including the ability to develop clear and concise presentations) are required as well as the ability to effectively collaborate with other team members.
- Proven analytical and decision-making skills; interpersonal, oral and written. In addition to his or her core competency, the successful candidate will have established a broad working knowledge of core pharmaceutical disciplines, including clinical development, regulatory affairs, manufacturing, translational medicine, intellectual property,
- Proven ability to work within a team environment, effectively lead projects and drive them to conclusion.
- Self-starter who works with a sense of urgency and functions as a strong team player effectively working with other disciplines.
- Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a small company environment.
- Proven ability to proactively identify challenges, possess strategic foresight and implement appropriate course of action