Director/Senior Director, Project Management
Reporting to the Vice President, Scientific Operations, the Director/Senior of Project Management will provide strategic leadership, operational management, support, and oversight of commercial-, clinical- and discovery-stage development project teams. As part of a cross-functional team, he/she will be responsible for all planning and execution of activities related to the project teams’ work, and ensure that all program deliverables are implemented on time, within scope, and on/or under budget.
Specifically, the Director/Senior Director of Project Management will:
- Work with cross-functional teams to define project strategy, scope, goals and deliverables to support business objectives in collaboration with senior management and stakeholders.
- Create agendas, minutes and presentations to lead project team meetings and ensure action items are completed.
- Oversee project timelines, project budgets and resource tracking tools.
- Work with Finance to ensure that appropriate budgets and forecasts are maintained to deliver agreed upon milestones.
- Develop presentations, analyses and recommendations for the executive leadership and stakeholders.
- Proactively identify risks and identify/implement mitigation plans.
- Raise and clearly communicate critical issues and their impact to the appropriate stakeholders in a manner that results in resolution and allows others to do the same.
- Effectively communicate project expectations to team members and stakeholders in a timely and clear manner.
- Participate in meetings with regulatory authorities.
- Observe all Trevena policies, SOPs and safety guidelines.
- Perform other duties, as necessary.
Up to 10% domestic/international travel.
EDUCATION & EXPERIENCE
- BS/MS in scientific field required.
- Ten years’ experience leading clinical stage projects in the pharmaceutical/biotech industry.
- Previous experience interacting with regulatory authorities preferred.
- Experience developing drugs that target the central nervous system preferred.
- Experience managing others is preferred.
KNOWLEDGE, SKILLS & ABILITIES
- In-depth knowledge of drug development process (i.e. experience in discovery-stage and Phase I - IV clinical development programs, regulatory submissions and commercialization).
- Substantial knowledge of clinical and preclinical development, CMC, QA, regulatory affairs, commercial and BD.
- Proven track record of successful IND and/or NDA filings.
- Strong sense of urgency with the ability to proactively identify and respond to issues and opportunities.
- Demonstrated strategic thinker with the ability to continuously consider the broader company impact of decisions and actions.
- Ability to influence and partner with line managers to complete project tasks in a timely fashion.
- Ability to manage project-specific timelines and budgets.
- Excellent written and oral communication skills. Outstanding presentation skills.
- Results oriented with a track record of taking full accountability for actions and outcomes.
- Resourceful and creative with a demonstrated ability for tackling challenges with enthusiasm.
- Outstanding interpersonal skills.
Equal Opportunity Employer.
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