Position HR034 – Project Manager Clinical Product Development
Location: Bridgewater, NJ
Nevakar is a specialty injectable bio-pharmaceutical development company, based in Bridgewater, New Jersey.
Products targeted for development by Nevakar are expected to address unmet clinical and commercial needs of currently available molecules, and thereby offer value proposition to patients, prescribers and payors. These products will be filed with FDA, primarily under 505(B)(2) regulatory pathway.
Incumbent will manage and coordinate product development activities for Clinical projects. Evaluates and resolves technical feasibility, design optimization, and production issues. Manages Clinical project budgets and prepares status and risk management reports for top management. Familiar with a variety of the field’s concepts, practices, and procedures. Relies on experience and judgment to plan and accomplish goals. A wide degree of creativity and latitude is expected. This position will report into the VP Program Management.
- (independently) Organizes and provides management of strategy development for moderately to complex projects within the scope of the Nevakar Development Process and Procedures.
- Manages the development and maintenance of program and clinical project plans from a scope, timing, and budget perspective.
- Responsible for management of the project critical path across all involved functions, including proactive management of non-critical path activities
- Provides project management support to clinical study teams to ensure appropriate scope management, study planning and control.
- Generates and maintains high quality program status, including risk/opportunity identification and mitigation plans.
- Establishes and maintains high performing project (sub) teams.
- Key Qualifications: BS/MS degree with significant prior project management experience (3+), including management of Phase 2 / 3 studies and submissions.
Education and Experience:
- At least Bachelor’s degree, preferably advanced degree, from an accredited college/university (a degree in life sciences, engineering or medically related field is strongly preferred).
- Project Management Professional (PMP) certification is a plus
- Minimum 5 years project management experience with 3+ year’s relevant experience in biotechnology, life sciences, pharmaceutical field
- Good understanding of overall Clinical product development, including management of phase 2/3 studies
- Proficiency in project management principles, practices, and tools (is required
- Demonstrated experience in strategic planning, project execution, control, risk and resource management for a globally networked organization is desirable
- Detailed understanding of what drives resource requirements
- Experience in successfully coordinating across several complex functions to ensure comprehensive and consistent planning and execution.
- Experience with the preparation of reports and/or presentations/communications via presentation tools such as PowerPoint, project dashboards and written reports