JOB OPENING: Preclinical Translational Project Manager

Job Summary:
Working within Center for Developmental Therapeutics, the Preclinical Translational Project Manager will work directly with Northwestern faculty and the CDT and INVO Entrepreneur-In-Residence (EIR) positions to speed translation of potential new therapeutics and diagnostics and improve efficiency by developing, monitoring, and updating timelines and milestones required to move innovations from the lab bench to the clinic. 
The Preclinical Translational Project Manager must be familiar with pre-clinical and clinical study design. Specifically, this position will be in charge of:
  • Mapping the process of asset development from target identification to FIH study, and facilitating discussions on which components NU should/may perform or outsource
  • Overseeing and mentoring faculty on the technical and administrative operations to get to a clinical trail
  • Preparing communications and submissions for FDA (IND,IDE, 510k, PMA)
  • Managing enabling studies for FDA submission
  • Managing submission protocols at NU animal research facility, NU IRB & FDA.   
The Preclinical Translational Project Manager will also coordinate relationships with vendors and other external partners, and assist with reporting and communication of activities to NUCATS leadership and external partners. This position will be responsible for coordinating activities with cores and vendors, management of budgets, reaching out and interacting with external partners to determine appropriate milestones have been set, and coordinating with the EIRs to identify go/no go decisions as the project moves down the path toward completion. The Preclinical Translational Project Manager will track project progress and provide updates to CDT leadership and the evaluation group on a quarterly basis.
Position occasionally requires willingness/ability to work extended hours as well as travel between both campuses.
Specific Responsibilities:
  • Manages the day-to-day operations of the Innovation Accelerator Team; 
  • Maintains updated records on all projects in the pipeline;
  • Manages portfolios and map out each step going forward;
  • Formulates drug development plans and walk the faculty through the project;
  • Manages relationships with vendors and other external partners including managing all outsourcing, CRO activities;
  • Prepares reports and communicate activities to CDT, NUCATS, and INVO leadership and external partners including participation in committees, meetings and presentations to the external advisors;
  • Collaborates with faculty to develop submission protocols; 
  • Works closely with faculty and providing mentorship for operations assistance through drug development;
  • Advices faculty on regulatory requirements to run pre-clinical and clinical studies;
  • Performs related duties as required or assigned.
Minimum Qualifications:
  • A PhD in a health or science related field or the equivalent combination of education, training and experience from which comparable skills can be acquired;
  • 5 years’ drug development experience;
  • IND experience;
  • Resourceful and creative problem-solver;
  • Ability to multi-task, and display good judgment in decisions and recommendations;
  • Strong organizational and quantitative skills;
  • Ability to maintain excellent working relationships with faculty and staff, and working in a team;
  • Ability to work autonomously and with minimal direction;
  • Demonstrated leadership skills;
  • Ability to achieve a standard of excellence with work processes and outcomes, honoring University policies and all regulatory requirements;
  • Ability to strive for high client satisfaction, going out of your way to be helpful and pleasant, making it as easy as possible on the client rather than our department or the University;
  • Excellent verbal, written, and interpersonal skills; balancing listening and talking, speaking and writing clearly and accurately, influencing others, keeping others informed;
  • Ability to be helpful, respectful, approachable and team-oriented, building strong working relationships and a positive work environment;
  • Ability to take ownership of work, doing what is needed without being asked, following through;
  • Ability to plan ahead, manage time well, be on time, be cost conscious, think of better ways to do things;
  • Ability to be receptive to feedback, willing to learn, embracing continuous improvement.
Preferred Qualifications:
  • Biotech drug development/device and regulatory experience;
  • Experience working in an academic environment;
  • Experience with project management and productivity tools.
To Apply:
·         Submit application through Northwestern University’s online career website http://www.northwestern.edu/hr/careers/
·         JobID: 22962
·         Please include 3 references
 
As per Northwestern University policy, this position requires a criminal background check.  Successful applicants will need to submit to a criminal background check prior to employment.

 

Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes including veterans and individuals with disabilities.