Our client is a clinical-stage biotechnology company. They have asked us to assist them in a search for a Project Manager.
Major tasks and responsibilities include:
- Generates and maintains detailed program plan and budgets and support the execution of deliverables and evaluation of scenarios.
- Develops, maintains, and aligns accurate, integrated program timelines, and integrated cross-functional planning, including associated budgets and risk assessment/mitigation plans.
- Convenes cross-functional team forums to address key program activities.
- Monitors progress of portfolio/program strategy, goals, and metrics.
- Understands critical path activities and assists in creating contingency plans. Proactively identifies issues and facilitates problem-solving, contingency planning, and decision-making.
- Anticipates bottlenecks and clear barriers to progress program level scenario planning and risk management.
- Supports the team in administration and management of cross-functional internal and external teams. With partnered/collaborative programs ensures communication, activities, and alignment, working with function heads, program leaders and BD/alliance management.
- Manages effective meetings, agendas, minutes, decisions log, action items and follows up, ensuring actions and deliverables are met and facilitates decision-making process working with the Program Leader.
- Maintains Integrated Program Plans covering all aspects of the drug development process from initiation to IND file and into clinical trials and registration.
- Informs key stakeholders of status, issues, and proposed solutions as appropriate.
- Supports Program Leaders in managing outsourced project activities with consultants and CROs as required to ensure contracting, work plan definition and delivery to time and budget.
We seek candidates with the following qualifications:
- Ensures central access to key program documents, presentations, and assessments. Works closely with each team to ensure collaborative team communication solutions. Prepares independent periodic reports.
- Proactively identifies internal/external resource gaps and works with function heads and Program Leaders to rebalance priorities or identify alternate solutions.
- Is accountable for integration of program/portfolio planning and strategy between team functions.
- Works with senior leadership team to amalgamate program plans and summarize critical information into clear and accurate information to support decision making.
- An advanced degree in biomedical research/chemistry or related is required. Professional PM qualifications (PMP, Prince2) are an advantage.
- Prior experience working in a biotech or pharma company with exposure to preclinical or early clinical development projects is required. Additional experience in cell or gene therapy clinical programs, especially in rare diseases or ophthalmology is preferred.
- Must have experience in project management of programs from concept to development candidate and through IND file into first in man and proof-of-concept clinical trials. A good understanding of pre-IND development is an advantage.
- Requires the ability to create, coordinate, and maintain integrated project plans with their source material/data and to control or respond to changes in strategy and scope, including scenario planning and decision trees.
- Competent use of project management software solutions, including skills in critical path analysis is required.
- Must have effective meeting management tools and techniques, with knowledge of decision-making, team building, stakeholder management, alignment, and conflict resolution techniques.
- An understanding of financial and resource planning systems and experience in budget management is required.
- Prior experiences with clinical trial operations or manufacturing or gene and cell therapy or ophthalmology projects are preferred.
- Excellent judgement in making trade-off decisions for program scope, costs and strategy are essential.
- Experience with Risk Management and Contingency Planning is required.
- Must be a proactive, detail-orientated individual with a style that ensures effective interfacing with cross-functional teams and across cultures and geographies.
- Must have excellent oral and written communication, interpersonal, analytical, and computer skills.
- Strong organizational skills are required, including good time management skills. Must be able to work independently on multiple tasks.
- Must be able to synthesize complex concepts into focused materials for decision-making.
- The demonstrated ability to foster collaboration and positive team environment is required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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