Senior Director, Project Management

SUMMARY
The individual is responsible for Prometheus Project management of internal and collaboration programs. The individual works closely with the executive team, functional managers and multi-functional project teams to ensure that the Projects are scoped, prioritized, initiated, developed and commercialized in conjunction corporate and collaboration partner goals and objectives. Programs include therapeutic and companion diagnostic (CDx) new product discovery, development, regulatory submissions and clinical studies essential to achieve business objectives.


ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Specific project duties include:

• Provides project leadership to guide the project team in the development and launch of both therapeutic and CDx products.
• Leads CDx projects utilizing the Design Control regulatory structure for in vitro diagnostic products and therapeutic products regulated through the Investigational New Drug (IND) application, New Drug Application (NDA) and Biologics License Application (BLA) regulatory processes.
• Manages all aspects of assigned projects: project charter, scope, planning, scheduling, tracking, resource requirements monitoring, and reporting using established project management methodology.
• Facilitates the establishment of cross functional team roles and responsibilities and team norms.
• Ensures project goals and objectives are well understood by the project sponsor(s) and impacted functional areas.
• Leads team meetings for planning, execution and tracking progress towards project deliverables.
  • Effectively communicates project progress, timeline, issues and risks to Senior Management and other key stakeholders within the organization, generated periodic status reports, and prepares formal presentations for internal governance meetings.
• Anticipates and identifies schedule slips or changes to plan and analyzes the scope, cost and resource impact and communicates accordingly.
• Ensures project team compliance with applicable company guidelines and regulatory documentation requirements.
• Develops, manages and tracks project resource requirements within an established financial framework. Partners with Finance to develop the project financial package including business value and cost for business planning.
• Leads conflict resolutions and negotiations internally and externally as required by projects.

INTERACTIONS

Interactions across all levels and functions of the organization. Works with Executive team, collaboration partners, Senior Management, R&D, Operations, Marketing, Finance, Safety and Human Resources to carry out duties. Works with all technical and business functions to identify, prioritize, monitor, and improve and/or commercialize products and processes.


PROBLEM SOLVING/DECISION MAKING

Monitors and keeps Executive management informed on project schedules, staffing and risks to timeline, budget and commercial viability of products in development. Undertakes company-wide resource planning to meet Program objectives.

Drives to timely decisions at the team level and when necessary at the Executive level. Schedules, holds and documents design reviews and/or other reviews to document key program decisions. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Responsible for adherence to Design Control and FDA/ISO compliant development, manufacturability and commercialization of therapeutic and diagnostic products.


SUPERVISORY RESPONSIBILITIES
None

QUALIFICATIONS

• Previous experience in biotech/pharma/diagnostics and project management preferred
• A general understanding of the drug and/or diagnostic development process
• Exceptional communication (written/oral) and interpersonal skills
• Strong ability to drive cross-functional and cross-organizational engagement
• Self-motivated and pro-active

The requirements listed below are representative of the experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

• BS degree in science field or business required. MS and/or MBA preferred.
• Minimum of 15 years of progressively increasing responsibility in R&D or Program Management.
• Requires sufficient combination of scientific experience and education to obtain a level of technical expertise to be able to direct the work of project team members.

KNOWLEDGE / SKILLS

• Excellent communication skills (verbal and written).
• Excellent project management skills including demonstrated ability to lead diagnostic and/or therapeutic programs.
• Strong leadership skills and the ability to foster strong interpersonal relationships between groups.
• Skilled in budgeting, planning, and building realistic timelines.
• Team oriented problem solving skills.
• Strong interpersonal skills and ability to work cross functionally.
• Strong skills in prioritization, organization and the ability to multitask.
• Accountable; driven to succeed.

MATHEMATICAL SKILLS
Ability to work with mathematical concepts including statistics. Facility in using Microsoft Office applications. Ability to read and analyze financial data.

REASONING ABILITY

• Ability to understand and utilize project management tools.
• Ability to define problems, collect data, establish facts and draw reasonable conclusions.
• Ability to interpret a variety of technical instruction in mathematical or diagram form.
• Ability to mentor, coach and train others.

CERTIFICATES, LICENSES, REGISTRATIONS

N/A


PHYSICAL DEMANDS
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 regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.


WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing 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 occasionally exposed to moving mechanical parts, fumes or airborne particles, potentially infectious bodily fluids, toxic or caustic chemicals, and extreme cold. The noise level in the work environment is moderate.

The noise level in the work environment is usually quiet.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.