Associate Director/Director Project Management - South San Francisco, CA
1 day ago
Job description
Location:
South San Francisco, CA – Hybrid, with the ability to be in office 2-3 days per week
Position 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 meetings
- Develop 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 timelines
- Establish project schedules needed for regulatory submissions (including IND submissions) and associated agency meetings
- Ensure 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 actions
- In 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 planning
- Working with Clinical Operations, support clinical vendor negotiations and management of contractual activities, including milestone tracking and spend to budget
- Drive scenario planning exercises as appropriate to ensure all potential options are identified and considered, with team alignment on path forward
- As needed, manage relationships with select CROs and other third-party vendors, ensuring adherence to commitments, timelines and budgets
- Ensure all program-related documents are accurate, complete, and filed appropriately
- Partner 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 timelines
Required Qualifications:
- Bachelor's or advanced degree in a relevant scientific or healthcare field, PMP certification a plus
- At least 7 years of experience in effectively supporting pre-clinical and clinical activities and regulatory filings
- Proven hands-on experience managing an integrated program plan directly leading to a successful regulatory submission
- Experience supporting large molecule programs in the dermatology / gastroenterology / immunology space a plus
- Proven ability to manage team timelines and budgets while maintaining high quality standards
- Experience negotiating clinical vendor contracts, including familiarity with typical terms & conditions
- Strong 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 deadlines
- Growth mindset and capable of working independently
- Strong project management skills
Compensation: $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.
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