CMC Project Manager
Description
ORIC Pharmaceuticals, is a clinical stage oncology company dedicated to improving patients’ lives and focused on developing treatments that address mechanisms of therapeutic resistance. We are seeking a highly motivated cross-functional and inter-institution project manager with a proven record of managing chemistry, manufacturing and control (CMC) projects and external collaborations with contract manufacturing and testing organizations (CXOs) to join our growing PharmSci group at ORIC Pharmaceuticals.
Position Summary
The candidate in this position is responsible for supporting Pharmaceutical Development (PharmDev) program management for one or more of ORIC’s novel therapeutic development products. Responsibilities will include supporting the internal PharmDev teams to progressively advance the nonclinical and clinical development of small molecule therapeutics to meet Development Team goals and coordination, oversight/management, and operational support of manufacturing and analytical activities conducted at CXOs. This individual will also be responsible for tracking Pharmaceutical Development timelines, budgets, invoices, CXO reports and documentation and may assist with regulatory filings. The successful candidate will report to the Sr. Director of Program and Project Management, and will be responsible for the following:
Essential Functions
- Work with the team to ensure uninterrupted clinical supply
- Provide technical project management and operational support for internal Pharmaceutical Development project teams.
- Define and monitor progress on deliverables and maintain timelines and budgets in alignment with Development Team goals, leveraging program management best practices.
- Ensure successful execution such that development projects achieve goals, objectives, and deliverables and progress towards regulatory and clinical milestones
- Collaborate closely and effectively with PharmSci functional reps, Regulatory affairs, Quality assurance, Finance, Commercial and Supply Chain teams, and Development Team to execute supply strategies seamlessly
- Actively manage the relationships, performance, and productivity of CXO partners to ensure maximum value from the service providers
- Document and file all reports, technical documents, and communications conducted with CXOs
- In partnership with PharmSci leadership and technical SMEs, implement service agreements with CXOs, forecast and track project budgets, and effectively partner with the Finance group to provide timely reconciliation of actual expenses against project budget
- Facilitate effective and open communications with all stakeholders
- Maintain and update a CMC risk register, track action items against the identified risks, and communicate/document status/resolution periodically and as needed
- Maintain and update internal integrated project plan and align with external partner deliverables, with timely communication to all impacted stakeholders
- Support effective and efficient meetings and ensure timely communication with all required stakeholders on any key risks, issues, and planned changes to approved scope
Requirements
- BS or MS or PhD in a relevant pharmaceutical sciences discipline with 2-6 years of relevant hands-on pharmaceutical/biotech industry experience in drug discovery and development
- Experience with cross-functional team roles and responsibilities in pharmaceutical development, with a track record of influencing and problem solving
- Awareness of ICH, GMP, quality systems, and regulatory guidances that impact drug development
- Demonstrated experience managing CMC project deliverables and timelines to ensure the project remains on schedule and within agreed to scope
- Experience working with project management methodologies including cross-functional project planning, budget development/accruals assessment, and project management software and visualization tools
- Proficiency working with Microsoft Project, OneNote, SharePoint, Excel, Word, and PowerPoint. Experience with portfolio management software such as SmartSheets is desirable.
- Familiarity with stage-appropriate CMC development strategies across pre-IND through NDA to commercial stages
- Familiarity with common issues and risks encountered during drug development and manufacturing
- Demonstrated ability to work independently, efficiently, and effectively in a collaborative, fast-paced, integrated, multidisciplinary team environment
- Strong interpersonal skills and able to effectively lead/facilitate in environment with site-based and remote team members
- Ability to quickly adapt and work with the team to find creative solutions to technical issues that arise
- Excellent oral and written communication skills. Succinct but thorough communication with attention to detail, analytical/critical thinking, and data organization, presentation, and inference
- Onsite in SSF preferred, with remote work negotiable
The anticipated salary range for candidates who will work in our South San Francisco location is between $103,000-$152,000 The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.
ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristic.