Outcomes Research

We are looking for a experienced indivisual who will be the independent Principal Investigator (PI) of projects responsible for overseeing all aspects of project delivery while delegating project management tasks to more junior scientific staff.  This role will also take scientific responsibility for project completion for a large project portfolio and be responsible for strategic consultation and for use of best methods to address research needs.  You will innovate scientifically and produce output of high scientific while assuming significant responsibility for sales targets and client development. You will also be responsible for the following areas:

Science

• Applies in-depth knowledge of scientific methods, both quantitative and/or qualitative
• Presents scientific work in peer-reviewed journals and at professional meetings
• Provides scientific leadership to team members
• Produces deliverables of high scientific quality
• Advises and implements best methods and scientific innovation in project plans and design
• Highly productive in terms of number and volume of scientific projects responsible for, involved  with, and consulting on
• Knowledge of regulatory requirements and guidelines
• Scientific contributions may include:
• Development and delivery of scientific studies and results directly to clients
• Assisting colleagues to optimize study design and implementation when scientist has specific areas of expertise
• Non-project related publications, presentations, workshops, advisory boards, participation in FDA meetings, etc.

Strategy/Consulting:

• Develops and maintains client relationships
• Understands pharmaceutical industry/FDA structure
• Identifies scientific methods/plans that help clients meet their goals as well as those that will not help clients meet their goals
• Provides scientifically rigorous deliverables that best help clients meet their objectives
• Helps clients prepare for regulatory meetings and attend regulatory meetings with clients as requested

Financial & Business Development:

• Brings in proposal leads
• Writes proposals and managing proposal writing process
• Closes sales
• Meets annual target utilization rate of 70%, unless otherwise specified

Project Management:

• Manages internal timelines to ensure that deliverables meet external client timelines
• Manages internal budget/staff hours per project not to exceed contracted budget
• Manages scope creep or out of scope work.
• Manages legal/contracting issues

OR Operations Support:

• Supervises mid- level scientific staff
• Develops and presents internal scientific trainings
• Participates in staff recruitment efforts (phone screening, interviewing, attending presentations, etc.)
• Conforms to SOPs and other requirements
• Actively supports new product development and scientific innovation

Key Performance Metrics:

• Revenue as PI (amount charged to projects throughout the year)
• Lead credits in Rap Sheets
• Sales credits in Rap Sheets
• Proposal writing credits in Rap Sheets
• Dollar volume of projects involved with – as PI/Co-PI, as a contributor to projects, as an internal consultant
• Scientific output – number of key deliverables (proposals, protocols, SAPs, final reports, evidence dossiers, abstracts/posters or podium presentations, manuscripts)
• Good citizenship / leadership and mentorship / operational & overhead work: recruiting, interviews, training, mentoring, supervising

Skills and Experience

• Strong analytical and problem-solving skills
• Deep and demonstrated understanding of OR project methods and strategy including qualitative methods, quantitative methods, and regulatory strategy
• Ability to successfully execute large, complex OR projects through implementation of best scientific methods, successful client management, and excellent oversight of project staff
• Ability to direct large portfolio of projects in terms of dollar volume and number of projects
• Able to provide oversight, management, and mentoring to more junior staff on OR projects
• Excel in ability to develop and maintain client relationships
• Excellent written and oral communication skills:  scientific, professional, and consulting
• Ability to develop positive, collegial, and productive relationships with colleagues and clients
• Excellent problem solving, time management, and logistic skills to be highly effective in fast-paced, deadline-driven work environment
• Deep understanding of health outcomes research principles and familiarity with key aspects of the literature (historical and current)
• Advanced level understanding of relevant methodology and statistics
• Extensive knowledge of practical research implementation
• Excellent communication skills including professional presentations
• Ability to critically review literature and contribute successfully to peer-reviewed literature in health outcomes.
• MS Word, PPT, Excel; familiarity with SAS or similar data analysis software

Education

• PhD in relevant scientific discipline (Psychology, Public Health, biomedical or life sciences) and very strong experience in relevant field; or
• Master's Degree  in relevant scientific discipline (Psychology, Public Health, biomedical or life sciences with extensive experience in relevant field.