Job Details
Description
ORIC Pharmaceuticals, Inc, 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 an effective cross-functional and inter-institution leader with a proven record of managing chemistry, manufacturing and control (CMC) projects to join our growing CMC group at ORIC Pharmaceuticals. The successful candidate will report to the Head of CMC Alliances.
The candidate in this position is responsible for leading CMC project management for one or more of ORIC's novel therapeutic development programs. Responsibilities will include the coordination, oversight/management, and operational support of manufacturing and analytical activities conducted at external partners (CROs and CMOs) and supporting the internal Pharmaceutical Development (PharmDev) teams to progressively advance the nonclinical and clinical development of small molecule therapeutics to meet Development Team timelines. This individual will also be responsible for tracking PharmDev reports and documentation, timelines, budgets, invoices, and assisting with regulatory filings.
Essential Functions
- Support the PharmDev teams to ensure uninterrupted clinical supply.
- Collaborate closely and effectively with CMC, RA, and QA leadership, and team members, to execute the internal and external supply strategies.
- Ensure development projects achieve key goals and deliverables, and progress toward milestones and regulatory filings, in alignment with PharmDev team timelines.
- Actively manage the relationships, performance and productivity of the external CMOs and/or CROs to extract maximum value from the service provider.
- Provide technical project management and operational support for the internal CMC project teams, schedule and manage joint team meetings with the CROs/CMOs, and track meeting minutes, and actions to completion.
- Facilitate effective and open communications with assigned project stakeholders.
- Document and file all reports, technical documents, and communications conducted with external partners (CMOs or CROs).
- Provide expert QC review with a scientific mindset of CMC section of regulatory documents, if and as necessary.
- In partnership with CMC leadership and contracts manager, implement service agreements with external CMOs and CROs, forecast and track project budgets for external studies, and effectively partner with the Finance group to provide timely reconciliation of actual expenses against project budget.
- Regularly meet with supervisor, and PharmDev team members to define and align strategies and manage tactical execution.
- 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 ORIC CMC/PharmDev timelines and align with external partner deliverables, with timely communication to all stakeholders of any changes.
Requirements - PhD in a relevant pharmaceutical sciences discipline with 12 years of relevant hands-on pharmaceutical/biotech industry experience, or BS/MS with equivalent experience, in the field of new drug discovery and development.
- Proven track record of cross-functional leadership, strategic direction, and problem solving.
- Working understanding of all CMC and drug discovery and development functions, and cross-functional drug development processes.
- Awareness and practical understanding of ICH, GMP, quality systems, and regulatory guidances that are important to consider in new drug product development.
- Demonstrated experience managing CMC project deliverables, scope, and timeline to ensure the project remains on schedule and within scope.
- Demonstrated ability to identify and analyze project risks and help guide teams to develop appropriate mitigation strategies
- Experience working with project management methodologies including cross-functional project planning, budget development/accruals assessment, and project management software (like Microsoft Project).
- Proficiency working with Microsoft Project, Excel, Word, and PowerPoint
- Working understanding of stage appropriate CMC development strategies across pre-IND through NDA to commercial stages.
- Working understanding of common issues associated with drug development and manufacturing.
- Demonstrated ability to work independently, efficiently, and effectively in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes work internally and with external partners, such as research organizations, CROs, CMOs, and CDMOs; and with employees both on-site and remote, in a hybrid environment.
- Demonstrated track record of being an effective leader. Able to lead and work as part of a team with strong interpersonal skills.
- Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met, as external environment and stakeholder input evolves.
- Excellent oral and written communication skills. Succinct but thorough communication skills with attention to detail, analytical/critical thinking, and data organization, presentation, and inference.
- Onsite, hybrid, or remote work are all possible
The anticipated salary range for candidates is between $190,000-$255,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. ORIC is a multi-state employee, and this salary range may not reflect positions that work in other states.
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.