POSITION SUMMARY:

Reporting to the VP, Technical Operations, and a dotted line to the CEO and President, the incumbent is responsible for leading the planning, coordination, and delivery of key projects that enable the project teams to achieve operational excellence and meet objectives. S/he will be responsible for project quality from delivery of concepts through the implementation of the final program/products. The Head of Operations will coordinate teamwork and/or personally deliver on key work efforts associated with the most important company objectives. S/he will be responsible for creating metrics and measures for the corporate level for board and executive management reviews on all company objectives and key drivers of those objectives as well as dashboards, metrics and statistical analysis of tracking execution of key, priority activity. Analysis includes non-financial forecasting (IE. enrollment projections, etc.), reporting and analysis. The incumbent will work with project teams and personnel in the US, Milan, Taipei, China as well as externally with licensing and key vendor partners.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:
Exercise organization-wide oversight over key projects and activities associated with achieving the organization's objectives in business development, clinical and regulatory development, manufacturing and supply, market assessment and investor relations support.
Assist project and function leaders by facilitating cross-functional teams, working with all relevant stakeholders to refine strategy, gather and document requirements and identify potential impact in terms of results (cost, risk, quality, timeliness)
Develop charts and dashboards that track core metrics for Corporate objectives, clinical planning and execution, enrollment modeling, tracking and forecasts, budget solves, logistics, manufacturing and supply activities, etc.
Ensure that effective project management governance, procedures, tools, and financial controls are established and maintained for the project’s operation.
Interface with stakeholders and this position’s senior management to confirm project sponsorship and support, agree on strategy and report progress, achievement and significant issues and risks.
Conduct problem solving and offer options and possible solutions. Facilitate problem identification and problem-solving discussions.
Develop operational-tactical plan including clinical planning and start-up activities, manufacturing and analytical tech transfers, capacity scale-up and API manufacturing.
Communicate project expectations (goals), scope, direction, approach, priorities, events, and status to all project resources team members.
Develop detailed project plans including milestones, timelines, corrective actions to problems or issues, anticipation of problems, and facilitation of scope management.
Build strong working relationships across departments, with key stakeholders, and Senior Management to ensure transparency and to facilitate communication.

YEARS OF EXPERIENCE:

5 - 10 years of pharmaceutical experience leading or coordinating cross-functional teams via Global Strategic Marketing or Program Management. Knowledge of Product Development, Regulatory requirements, Clinical Ops, Technology Transfers and Manufacturing Strategy.

PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger, handle, or feel objects or controls; reach with hands and arms; stoop, kneel, or crouch; and talk or hear. The employee may be required to sit for extended periods of time. The employee must frequently lift and/or move up to 20 pounds. Potential travel up to 20%.


OTHER SKILLS AND ABILITIES:

Self-starter leader. Enjoy being responsible for many different types of work from clinical development coordination to market assessments and business development support.
Excellent communication and problem-solving skills, negotiation skills, team building, and conflict resolution skills.
Ability to lead teams and influence other individuals that do not directly report to this position
Strong analytical skills supported by high degree of comfort with Excel spreadsheet work and PowerPoint
Project management (Microsoft Project) skills and handling of meetings.
Ability to drive performance and consistently deliver results

EDUCATIONAL REQUIREMENTS (degree, license, certification):

BS Degree in a technical field or in Project Management
CAPM/PMP certification preferred
Biotechnology, Pharmaceutical or Life Science Company experience