Associate Director/Director Project Management

Location: South San Francisco, CA – Hybrid, with the ability to be in office 2-3 days per weekPosition Summary:TRexBio is seeking a talented and highly motivated Project Manager (PM) to help drive our lead clinical program forward and establish project management best practices within our organization. This is a critical role responsible for partnering with the Program Team Lead to help drive clinical execution and coordination of our lead therapeutic program into the next phases of development. The ideal candidate will be instrumental in managing the cross-functional activities required for regulatory filings, ensuring adherence to program timelines, maintaining quality standards, negotiating clinical contracts, and helping manage communications of program status across the organization. This role requires a strong understanding of project management as it relates to clinical development activities for biologics.Key Responsibilities include but are not limited to:Actively partner with the Program Team Lead and serve as the cross-functional Project Manager for our lead clinical program, including participation in Core Team and Sub Team meetingsDevelop and maintain a master integrated project plan and timeline, highlighting key decision points, clinical activities, data readouts, regulatory touch points, interdependencies and critical risks. Accountable for accuracy and timeliness of information and act as the "single source of truth" for program timelinesEstablish project schedules needed for regulatory submissions (including IND submissions) and associated agency meetingsEnsure adherence to program timelines and budgets by closely monitoring project milestones and expenses. Identify and address any delays or budgetary concerns promptly and implement appropriate corrective actionsIn conjunction with PTL and sub team leads, manage all aspects of team operations including meeting facilitation, agenda development, drafting minutes, follow up, and implementation of team processes for planningWorking with Clinical Operations, support clinical vendor negotiations and management of contractual activities, including milestone tracking and spend to budgetDrive scenario planning exercises as appropriate to ensure all potential options are identified and considered, with team alignment on path forwardAs needed, manage relationships with select CROs and other third-party vendors, ensuring adherence to commitments, timelines and budgetsEnsure all program-related documents are accurate, complete, and filed appropriatelyPartner with PM team to identify and lead process initiatives and continuous improvement activities, including best practices & systems for documenting, tracking and communicating status of integrated development plans and timelinesRequired Qualifications:Bachelor's or advanced degree in a relevant scientific or healthcare field, PMP certification a plusAt least 7 years of experience in effectively supporting pre-clinical and clinical activities and regulatory filingsProven hands-on experience managing an integrated program plan directly leading to a successful regulatory submissionExperience supporting large molecule programs in the dermatology / gastroenterology / immunology space a plusProven ability to manage team timelines and budgets while maintaining high quality standardsExperience negotiating clinical vendor contracts, including familiarity with typical terms & conditionsStrong communication skills with a demonstrated ability to work collaboratively with cross-functional teams.High sense of accountability and urgency in order to prioritize deliverables and meet deadlinesGrowth mindset and capable of working independentlyCompensation: $190,000 - $210,000, plus Discretionary Bonus.TRexBio is a clinical stage biotechnology company leveraging cutting edge computational biology tools, a focus on human tissue, and expertise in immunobiology to develop revolutionary therapeutics for inflammatory diseases. Our powerful 'deep biology' discovery engine maps human tissue Treg behavior to disease processes, allowing us to identify and characterize novel targets for therapeutic intervention. Leveraging this platform, we are building a broad portfolio of novel therapies that modulate the immune system to restore human tissue immune homeostasis.Our Culture:At TRexBio, you will have the opportunity to work with amazingly smart humans who strive to make the world a better place. In addition to our team-centric culture, we believe that your individual creativity will help us to be our best. Our staff happy hours, organized by our Culture Club, bring us all together in creative and social activities. Our colleagues admire and respect one another. We celebrate our wins, update company news and acknowledge each other's achievement weekly and monthly at all company meetings that celebrate our work and our people.TRexBio is proud to be an AA/EEO employer and all qualified candidates will receive consideration without regard to characteristics protected by applicable local, state, or federal law, such as race, color, sex, age, religion, national origin, physical or mental disability, pregnancy, marital status, veteran or military status, genetic information, or sexual orientation.J-18808-Ljbffr