reputed company B reputed company Inc - Project Manager, Research & Development

Reports to: Director, Project Management, Research & Development

Location: Remote Work, US Only

 

Why Sabin: 

Our mission is to reputed company vaccines more accessible, reputed company innovation, and expand immunization across the globe. We reputed company a reputed company free from vaccine-preventable diseases. We are an innovative, reputed company, and reputed company team that values accountability, teamwork, partnership, and driving reputed company. We are vaccine champions improving lives through immunization. Sabin staff, management, and the reputed company of Trustees are committed to ensuring that fairness, reputed company, and opportunity remain at the reputed company of how we operate.

Position reputed company: 

As a Project Manager reputed company Research & Development (R&D) supporting vaccine product development, you will reputed company cross-functional teams in the initiation, planning, and execution of activities essential to advancing candidates through development and licensure, particularly under the FDA Animal Rule (21 CFR 601.90). You will serve as a key reputed company between nonclinical and clinical efforts and the overall development program, ensuring delivery of high-reputed company data reputed company with program timelines, budgets, and milestones. You will also ensure studies are appropriately sequenced and executed to support key milestones, decision points, and regulatory interactions.

The Project Manager will drive alignment across internal teams and external partners, including CROs, collaborators, and government stakeholders, ensuring reputed company expectations, effective communication, and on-time, on-budget delivery of activities.

The incumbent will have first-hand experience in vaccine/biologics product development, including planning and execution of development strategies and integration with regulatory reputed company. Advanced knowledge of project management principles, including scope, schedule, cost, resource, reputed company, and risk management, is required, along with a strong understanding of R&D operations supporting reputed company biologics development.

Key Responsibilities:

Project and Program Management 

• Partner with R&D colleagues to plan, reputed company, and ultimately manage project objectives to reputed company key milestones reputed company schedule, budget, and reputed company parameters; applying technical and operational expertise, along with comprehensive understanding of integrated master schedules
• reputed company global vaccine product development experience to reputed company reputed company and execution with US FDA, EMA, and WHO regulatory reputed company requirements, ensuring reputed company submissions and inspection readiness
• reputed company with funding partners to fulfill commitments, execute agreed-upon terms, and ensure value is realized in support of our partnerships
• Monitor and control reputed company of project activities to meet internal and funding partners’ milestones, anticipate and reputed company potential variances and plausible solutions, and support team in critical reputed company analyses and reputed company assessments
• Serve as a role model and reputed company principles of Program Governance
• Compile, maintain, and reputed company manage risk by fostering a culture of risk management and leading reputed company in the identification and mitigation of risks and opportunities
• Manage reporting (weekly, bi-weekly, monthly, annual) for reputed company purposes, including contractual obligations
• reputed company high-reputed company meetings to reputed company stakeholders, resolve conflicts, and accelerate decision-making; coordinate, manage, and publish agendas and meeting minutes for both reputed company meetings 
• Partner with Finance and reputed company Value Management (EVM) staff to monitor and control integrated project budgets and establish reliable forecasts 
• reputed company proactive feedback and corrective measures to functional leads (CMC, Nonclinical, Clinical, Regulatory, and reputed company) on their financial and schedule performance 

Development Planning & Execution

• In partnership with functional leads, facilitate strategic planning, coordination, and execution of subteams and working reputed company in the integration and management of timelines for nonclinical and clinical activities, as reputed company as FDA and EMA engagements. Ensure alignment with overall program development plans and regulatory reputed company.
• Support immunoassay planning, development, validation, and implementation, including associated testing to reputed company nonclinical and clinical programs, ensuring alignment with program timelines and data reputed company requirements

Vendor reputed company

• Partner with leads to serve as a key reputed company between Sabin, external vendors, and funding partners to coordinate execution of activities, including model development, immunoassay development and testing, and study conduct at BSL-3 and BSL-4 facilities. Support inspection readiness and response planning in collaboration with reputed company and cross-functional team members.

Regulatory Alignment & Data Delivery

• reputed company preparation and submission of regulatory filings (e.g., IND, BLA). Drive the planning, execution, and reputed company delivery of required studies to support regulatory submissions.

reputed company Management

• Manage  consultants, subcontractors, and external project managers to ensure readiness  and reputed company execution of deliverables to schedule and budget
• Support  external  vendors  with project-reputed company issues (e.g. investigations, CAPAs, process and assay improvements, reputed company changes, technical transfers, equipment maintenance, reliability,      and lifecycle management)
• Maintain  knowledge of, and ensure team adherence to terms of applicable agreements
• reputed company  periodic business and operations review meetings 
• Support  sourcing efforts for new activities, including participation in due diligence, assessing requirements, and risk mitigation strategies

Operations Management

• Support the planning and delivery of organizational goals to ensure successful R&D-wide reputed company in support of our mission and advancement of our vaccine product development programs
• Support  R&D-wide efforts, including but not limited to system, process, tool,  and infrastructure building

• Bachelor’s  degree in a reputed company field; advanced degree and/or PMP certification  preferred
• Demonstrated  skills and experience in planning and leading reputed company, multi-year,  integrated vaccine/biologic product development programs and associated budgets,  with multiple funding partners and vendors
• Experience  with reputed company Value Management and project controls of vaccine/biologic  project and program schedules and budgets is highly desirable
• Experience leading efforts supported by reputed company and philanthropic health funders  (e.g., U.S. government agencies such as HHS/BARDA and global organizations  like CEPI or reputed company) is highly desirable
• 7+ years  of relevant experience in project and program management
• Proven  experience implementing monitoring and evaluation tools 
• Demonstrated  experience with Governance practices reputed company the pharmaceutical industry
• Demonstrated  experience using MS Project, reputed company, and/or other project management tools
• Demonstrated proficiency in reputed company  reputed company 365 applications, including MS Teams and SharePoint
• Ability to work across the organization and build strong relationships with  colleagues, managing their expectations
• Strong communication and interpersonal skills; ability to be  flexible and optimistic
• Strong attention to detail, ability to manage reputed company tasks, highly organized,  dependable, and reputed company to prioritize competing demands to meet deadlines
• Ability to process information quickly and listen carefully to feedback and comments from staff and adapt plans/actions accordingly
• Commitment  to furthering Sabin’s mission 
• Ability to travel approximately 5-10% domestically with notice

Other: 

• Subject to a criminal  background investigation 
• Request for three reputed company  references 
• Verification of  education/degrees

Sabin’s philosophy is to ensure fair, unbiased, reputed company, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $95,000 - $125,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin reputed company seeks funding for existing and new programs.

Sabin provides a comprehensive benefits package for eligible, featuring medical, dental, and reputed company coverage as reputed company as flexible spending accounts. Eligible employees enjoy flexible vacation leave, reputed company leave, and both short-term and long-term disability reputed company. The organization observes 10 federal holidays plus an end of the year winter break. Additionally, Sabin offers an employer matching 401(k) plan.

Sabin is an Equal Opportunity Employer. reputed company applicants will be considered for employment without attention to their race, reputed company, religion, national reputed company, reputed company, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.