Director of Project/Program Management will support planning and execution of Recursion’s pipeline product development project(s) from discovery through human proof of concept. The successful candidate will work closely with CMC, Quality Assurance, Discovery Operations, Toxicology, Preclinical development, and Regulatory Affairs to develop and execute the integrated project plan for development of pipeline products.
Strong emphasis will be placed on communications, team building and management, and proactive execution of programs against budget and timelines. This position will be accountable for project progress, success, tracking and reporting, and management of communications and risk plans and mitigations. Will need to work closely with internal and external vendors, clients, stakeholders, and sponsors. PM may also support efforts associated with continuous improvement applying project lessons learned & best practices and driving awareness and implementation of those best practices across teams.
Will need to use advanced Project Management Methodologies. Must be able to work independently but also have the ability to work effectively in a team-based cross-functional environment.
Essential Functions and Responsibilities:
Ability to integrate science, development knowledge, and regulatory expectations to create and execute project plans.
Must have demonstrated practical experience and knowledge of small molecule development from pre-IND through BLA/MAA/NDA.
Must possess knowledge of related disciplines and principles as Manufacturing, cGMP, Quality Systems, GCP, FDA Guidelines, and Drug Development life cycle from Phase 1 – Phase 3.
Ability to design and implement project / study plans outside area of expertise a must.
Ability to collaborate with finance to manage projects against approved budgets.
May be required to perform various “hands on” tasks in order to advance activities (e.g. shepherding of protocols, reports, etc. through review cycles).
Demonstrated ability to work independently to manage complex project in a fast paced, ever-changing, cross-functional team-based environment.
Must be self-motivated and have the ability to build shared vision and common goals across teams(s).
Excellent people skills, especially in the area of consensus building and negotiation.
Must be able to effectively communicate and align plans with external parties.
Needs to be a proactive problem-solver with excellent judgment and strong analytic, leadership, and management skills.
Have the ability to incorporate leading edge thinking into project management practices and processes.
Is dedicated to meeting the expectations and requirements of internal and external vendors, stakeholders, and customers.
Excellent written and verbal communication, listening, negotiation, presentation, organizational and relationship-building skills required.
Demonstrated proficiency with Microsoft Office, WebEx, project management software tools.
Knowledge, Skills and Abilities:
Must have current or recent work experience in a biotech or pharm company managing early development programs. Project management experience in IT or other disciplines will not be considered.
Minimum of 10 years product development experience required.
Minimum of 5 years of Project Management experience in Biotech / Biopharma environment an absolute must.
Comprehensive working knowledge of GMPs, GCP, and Regulatory Guidance Documents as they relate to development of biopharmaceutical products.
PMP or equivalent certification preferred.
Must have very strong computer skills (PowerPoint, Excel, MS Project, Visio, etc.).
Ability to effectively prioritize and deliver on tight timelines.
Accuracy and attention to detail.
Excellent cross-functional team building / participation skills.
Outstanding problem solving abilities.